Clinical Pharmacology

‘Lives are at stake’: Roque hit for saying Metro Manila is ‘living experiment’ in gov’t COVID-19 response | 7/29/2020

… case doubling rate and the critical care capacity. Case doubling rate refers to “the number of days it takes for the number of cases, hospitalizations, or deaths to double,” according to infectious diseases and clinical pharmacology expert Dr. Benjamin Co . Roque said that the NCR’s case doubling rate is “fine” at 8.9% but the critical care capacity, which refers to isolation beds and wards for COVID-19 patients, is the …

The 5-Second Trick For buy xanax online | 7/29/2020

… the initiation of treatment method with XANAX. A diminished systemic alprazolam elimination charge (eg, greater plasma 50 %-life) has become observed in both equally alcoholic liver disease clients and obese clients receiving XANAX (see CLINICAL PHARMACOLOGY).Should you be insured, you are able to inquire your pharmacist to match the The usa’s Pharmacy low cost with all your coverage copay, to be able to pay back the bottom available selling …

Follow Clinical Pharmacology:    

Published research work adds value to CV | Deccan Herald | 7/29/2020

Dear Madam, I have completed MBBS and want to pursue post graduation in the UK. What is the procedure? What are the courses I can take up? VJ Sathyaa Dear Sathyaa, UK universities offer MSc in Cardiovascular Sciences, Clinical Critical Care, Clinical Genetics, Clinical Neuropsychology, Clinical Pharmacology , Diabetes, Health Care, Advanced Practice, Medical Genetics & Genomics etc. All master’s programmes in the UK are for a duration of one year. Take …

Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea - 10/27/2020 - 10/27/2020 | 7/29/2020

The purpose of the public virtual workshop is to discuss the nonclinical and clinical pharmacology data and clinical trial design considerations regarding developing antimicrobial drugs for the treatment of gonorrhea. ABOUT THE PUBLIC WORKSHOP FDA, NIAID and CDC are announcing a public workshop regarding the development considerations of antimicrobial drugs for the treatment of gonorrhea. The workshop will focus on the current state and nonclinical and clinical trial design considerations …

Withings raises $60 million to bridge the gap between consumer tech and healthcare providers | TechCrunch | 7/28/2020

… Board, which Letombe says they’ve actually been working with for a year but that they’re only announcing publicly alongside this funding. The board includes Mayo Clinic Platform President, Dr. John Halamka; former head of Clinical Pharmacology in Hôpital Européen, Georges Pompidou; Dr. Stéphane Laurent; and former head of Clinical Innovation at Pfizer Craig Lipset — top medical professionals across respected institutions and one of the largest therapeutics companies in the world …

Treatment algorithm for the use of psychopharmacological agents in individuals prenatally exposed to alcohol and/or with diagnosis of fetal alcohol spectrum disorder (FASD) | 7/28/2020

edmontonfetalalcoholnetwork Research , Uncategorized Leave a comment Journal of Population Therapeutics & Clinical Pharmacology Mansfield Mela, Ana Hanlon-Dearman, A. G. Ahmed, Susan D. Rich, Rod Densmore, Dorothy Reid, Alasdair M. Barr, David Osser, Tara Anderson, Bola Suberu, Osman Ipsiroglu, Hasu Rajani, and Christine Loock DOI: 10.15586/jptcp.v27i3.681 ABSTRACT Psychotropic medication treatment of individuals who have experienced prenatal alcohol exposure (PAE) has lagged behind psychosocial interventions. Multiple psychotropic medications are often prescribed …

No clear evidence statin use in athletes harms exercise performance | 7/27/2020

… they don’t, I often have to accept the patient’s conclusion.” Evidence base The question of whether statins might be problematic in athletes stemmed from findings from a study published in the British Journal of Clinical Pharmacology in 2004, Thompson said. The study assessed data from 22 professional athletes with LDL receptor defects and found that only six could tolerate statins despite multiple attempts with other statins. Paul D. Thompson In …

OMEPRAZOLE capsule, delayed release [NorthStar Rx LLC] | National Institutes of Health | 7/27/2020

… acid-mediated GERD. Use of omeprazole in this age group is supported by adequate and well-controlled studies in adults and uncontrolled safety, efficacy and pharmacokinetic studies performed in pediatric and adolescent patients [see Clinical Pharmacology (12.3) , Clinical Studies (14.8) ]. In the pediatric population, adverse reactions of the respiratory system were frequently reported in the entire (2 to 16 years) age group. Accidental injuries were frequently reported in the 2 …

CABOMETYX (cabozantinib) tablet [Exelixis, Inc.] | National Institutes of Health | 7/27/2020

… Other Drugs on CABOMETYX Strong CYP3A4 Inhibitors Coadministration of a cabozantinib capsule formulation with a strong CYP3A4 inhibitor increased the exposure of cabozantinib, which may increase the risk of exposure-related adverse reactions [see Clinical Pharmacology (12.3) ] . Avoid coadministration of CABOMETYX with strong CYP3A4 inhibitors. Reduce the dosage of CABOMETYX if coadministration with strong CYP3A4 inhibitors cannot be avoided [see Dosage and Administration (2.5) ] . Avoid grapefruit or grapefruit juice which …

ARIPIPRAZOLE tablet [Preferred Pharmaceuticals, Inc.] | National Institutes of Health | 7/27/2020

… clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) The concomitant use of aripiprazole with strong CYP 3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of aripiprazole alone [ see Clinical Pharmacology ( 12.3) ] . With concomitant use of aripiprazole with a strong CYP3A4 inhibitor or CYP2D6 inhibitor, reduce the aripiprazole dosage [see Dosage and Administration ( 2.7 )] . Strong CYP3A4 Inducers (e.g., carbamazepine, rifampin) The concomitant use of aripiprazole …

VENLAFAXINE HYDROCHLORIDE capsule, extended release [Zydus Pharmaceuticals (USA) Inc.] | National Institutes of Health | 7/27/2020

… 2 DOSAGE AND ADMINISTRATION Venlafaxine hydrochloride extended-release capsules should be administered in a single dose with food, either in the morning or in the evening at approximately the same time each day [ see Clinical Pharmacology ( 12.3 ) ]. Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water or it may be administered by carefully opening the capsule and sprinkling the entire contents on …

METOPROLOL TARTRATE tablet, film coated [A-S Medication Solutions] | National Institutes of Health | 7/27/2020

… hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red 30 Aluminium Lake and 100 mg tablet contains FD&C Blue 2 Aluminium Lake as coloring agents. CLINICAL PHARMACOLOGY Mechanism of Action Metoprolol tartrate is a beta 1 -selective (cardioselective) adrenergic receptor blocker. This preferential effect is not absolute, however, and at higher plasma concentrations, metoprolol also inhibits beta 2 -adrenoreceptors, chiefly located …

AMLODIPINE BESYLATE tablet [A-S Medication Solutions] | National Institutes of Health | 7/27/2020

… results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology ( 12.3 )] . CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is coadministered with CYP3A inducers. Sildenafil Monitor for hypotension when …

STALEVO (carbidopa, levodopa, and entacapone) tablet, film coated [Novartis Pharmaceuticals Corporation] | National Institutes of Health | 7/27/2020

… higher levodopa dose may lead to an overdose of entacapone. Administer Stalevo with or without food. However, a high-fat, high-calorie meal may delay the absorption of levodopa by about 2 hours [ see Clinical Pharmacology (12.3) ] . 3 DOSAGE FORMS AND STRENGTHS Each Stalevo tablet, provided in 6 single-dose strengths, contains carbidopa and levodopa in a 1:4 ratio and a 200 mg dose of entacapone. Stalevo (carbidopa, levodopa and …

CADUET (amlodipine besylate and atorvastatin calcium) tablet, film coated [Pfizer Laboratories Div Pfizer Inc] | National Institutes of Health | 7/27/2020

… first, or second-degree relative, or two or more other CVD risk factors are present. Use of atorvastatin for this indication is supported by evidence from [see Dosage and Administration (2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.11) ] : A placebo-controlled clinical trial of 6 months duration in 187 boys and postmenarchal girls, 10 years to 17 years of age. Patients treated with 10 mg or 20 …

EZETIMIBE tablet [Aurobindo Pharma Limited] | National Institutes of Health | 7/27/2020

… these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3) ] . 8.6 Renal Impairment When used as monotherapy, no dosage adjustment of ezetimibe is necessary. In the Study of Heart and Renal Protection (SHARP) trial of 9270 patients with moderate to severe renal impairment …

EPCLUSA (velpatasvir and sofosbuvir) tablet, film coated [Gilead Sciences, Inc.] | National Institutes of Health | 7/27/2020

… Clinically Significant Interactions with EPCLUSA Based on drug interaction studies conducted with the components of EPCLUSA (sofosbuvir or velpatasvir) or EPCLUSA, no clinically significant drug interactions have been observed with the following drugs [see Clinical Pharmacology (12.3) ]: EPCLUSA: atazanavir/ritonavir, cyclosporine, darunavir/ritonavir, dolutegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, raltegravir, or rilpivirine. Sofosbuvir: ethinyl estradiol/norgestimate, methadone, or tacrolimus. Velpatasvir: ethinyl estradiol/norgestimate, ketoconazole, or pravastatin. See Table 4 …

CELECOXIB capsule [UMEDICA LABORATORIES PRIVATE LIMITED] | National Institutes of Health | 7/27/2020

… impairment (Child-Pugh Class B), reduce the dose by 50%. The use of celecoxib in patients with severe hepatic impairment is not recommended [ see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 ) ]. Poor Metabolizers of CYP2C9 Substrates In adult patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin …

RISPERDAL CONSTA (risperidone) kit [Janssen Pharmaceuticals, Inc.] | National Institutes of Health | 7/27/2020

… Other CYP Isozymes Risperidone is metabolized to 9-hydroxyrisperidone by CYP 2D6, an enzyme that is polymorphic in the population and that can be inhibited by a variety of psychotropic and other drugs [see Clinical Pharmacology (12.3) ] . Drug interactions that reduce the metabolism of risperidone to 9-hydroxyrisperidone would increase the plasma concentrations of risperidone and lower the concentrations of 9-hydroxyrisperidone. Analysis of clinical studies involving a modest number …

SUMATRIPTAN injection, solution [AuroMedics Pharma LLC] | National Institutes of Health | 7/27/2020

… of each other is contraindicated. 7.2 Monoamine Oxidase-A Inhibitors MAO-A inhibitors increase systemic exposure by 2-fold. Therefore, the use of sumatriptan injection in patients receiving MAO-A inhibitors is contraindicated [ see Clinical Pharmacology (12.3) ] . 7.3 Other 5-HT 1 Agonists Because their vasospastic effects may be additive, coadministration of sumatriptan injection and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated …

SOFOSBUVIR AND VELPATASVIR (velpatasvir and sofosbuvir) tablet, film coated [Asegua Therapeutics LLC] | National Institutes of Health | 7/27/2020

… Sofosbuvir and Velpatasvir Based on drug interaction studies conducted with sofosbuvir, velpatasvir, or sofosbuvir and velpatasvir tablets (400 mg/100 mg) no clinically significant drug interactions have been observed with the following drugs [see Clinical Pharmacology (12.3) ]: Sofosbuvir and velpatasvir: atazanavir/ritonavir, cyclosporine, darunavir/ritonavir, dolutegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, raltegravir, or rilpivirine. Sofosbuvir: ethinyl estradiol/norgestimate, methadone, or tacrolimus. Velpatasvir: ethinyl estradiol/norgestimate, ketoconazole, or pravastatin. See …

SOLIFENACIN SUCCINATE tablet, film coated [Teva Pharmaceuticals USA, Inc.] | National Institutes of Health | 7/27/2020

… and connective tissue disorders : muscular weakness. 7 DRUG INTERACTIONS 7.1 Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [see Clinical Pharmacology ( 12.3 )] . The dosage of solifenacin succinate greater than 5 mg once daily is not recommended when concomitantly used with strong CYP3A4 inhibitors [see Dosage and Administration ( 2.4 )] . 8.1 Pregnancy Risk Summary There are no …

BAXDELA (delafloxacin meglumine) tablet BAXDELA (delafloxacin meglumine) injection, powder, lyophilized, for solution [Melinta Therapeutics, Inc] | National Institutes of Health | 7/27/2020

… patients [see Warnings and Precautions (5.8) ] . In elderly subjects (≥ 65 years), the mean C max and AUC ∞ of delafloxacin were about 35% higher compared with young adults, which is not considered clinically significant [see Clinical Pharmacology (12.3) ] . 8.6 Hepatic Impairment No dosage adjustment is necessary for BAXDELA in patients with hepatic impairment [see Clinical Pharmacology (12.3) ]. 8.7 Renal Impairment No dosage adjustment of BAXDELA is necessary in patients with mild …

MESALAMINE tablet, delayed release [Sun Pharmaceutical Industries, Inc.] | National Institutes of Health | 7/27/2020

… parallel group trial in 105 pediatric patients 5 to 17 years of age, and additional pharmacokinetic analyses. The safety profile in pediatric patients was similar to that observed in adults [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.2)] . The safety and effectiveness of mesalamine have not been established in patients weighing less than 24 kg. 8.5 Geriatric Use Clinical trials of mesalamine did not include sufficient numbers of …

PROMETHAZINE HYDROCHLORIDE tablet [Clinical Solutions Wholesale] | National Institutes of Health | 7/27/2020

… promethazine hydrochloride. In addition each tablet contains the following inactive ingredients: dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. Promethazine Hydrochloride Tablets USP, 50 mg also contain anhydrous lactose. CLINICAL PHARMACOLOGY Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its …

Food and Drug Administration

ACETAMINOPHEN AND CODEINE PHOSPHATE tablet [Clinical Solutions Wholesale, LLC] | National Institutes of Health | 7/27/2020

… Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products ( see WARNINGS ). Under … crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid. CLINICAL PHARMACOLOGY Mechanism of Action Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine …

National Cancer Institute

Bergenbio Announces First Patient Dosed in Recurrent Glioblastoma Investigator Sponsored Phase I/II Study Assessing Selective AXL Inhibitor Bemcentinib | PR Newswire | 7/20/2020

… of Neurosurgery and co-leader of the Neuro-Oncology Program at University of Alabama at Birmingham and funded by the National Cancer Institute (NCI). This is an open label, multi-centre, intra-tumoral tissue pharmacokinetic … Prof. Jeff Supko , Harvard Medical School and Director of the Clinical Pharmacology Laboratory, Massachusetts General Hospital ( Boston , USA ). Prof. Burt Nabors MD, the Chairman of the trial and Director of Neuro-Oncology at University of …

Clinical Research

Bergenbio Announces First Patient Dosed in Recurrent Glioblastoma Investigator Sponsored Phase I/II Study Assessing Selective AXL Inhibitor Bemcentinib | PR Newswire | 7/20/2020

Clinical Pharmacology Laboratory, Massachusetts General Hospital ( Boston , USA ). Prof. Burt Nabors MD, the Chairman of the trial and Director of Neuro-Oncology at University of Alabama at Birmingham (UAB) and Director of UAB’s Centre for Clinical Translational Science’s Clinical Research Unit, commented: “GBM is among the most lethal of adult cancers. The median survival of patients remains less than two years despite the current available therapies, including surgery, radiation, and …

Accreditation Council for Continuing Medical Education

The 2020 Annual Meeting of the American College of Clinical Pharmacology® is Now a Virtual Meeting! | PR Newswire | 6/30/2020

The 2020 Annual Meeting of the American College of Clinical Pharmacology® is Now a Virtual Meeting! News provided by Jun 30, 2020, 08:47 ET Share this article ASHBURN, Va. , June 30, 2020 /PRNewswire/ – The American … virtual STEP Networking Social. ACCP is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE) and the American Nurses Credentialing Center (ANCC), to provide continuing education …

Medical Education

The 2020 Annual Meeting of the American College of Clinical Pharmacology® is Now a Virtual Meeting! | PR Newswire | 6/30/2020

The 2020 Annual Meeting of the American College of Clinical Pharmacology® is Now a Virtual Meeting! News provided by Jun 30, 2020, 08:47 ET Share this article ASHBURN, Va. , June 30, 2020 /PRNewswire/ – The American … ACCP is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE) and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team …

Credentialing

The 2020 Annual Meeting of the American College of Clinical Pharmacology® is Now a Virtual Meeting! | PR Newswire | 6/30/2020

The 2020 Annual Meeting of the American College of Clinical Pharmacology® is Now a Virtual Meeting! News provided by Jun 30, 2020, 08:47 ET Share this article ASHBURN, Va. , June 30, 2020 /PRNewswire/ – The American … Accreditation Council for Pharmacy Education (ACPE) and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. About ACCP ACCP is a non-profit association providing accredited Continuing Education, publications and …

Center for Drug Evaluation and Research

Senior Pharmaceutical Drug Development Executive, Philip Chaikin, PharmD, MD, FCP, Joins NDA Partners as Expert Consultant | PRWeb | 6/17/2020

… today that Dr. Philip Chaikin, a senior pharmaceutical industry executive with extensive drug development experience in development strategy, regulatory strategy, clinical pharmacology, and clinical study design, has joined the firm as an Expert Consultant. Throughout … with the US Food and Drug Administration (FDA), including the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), European regulatory bodies, and the European Medicines Agency (EMA) and …

Regenerative Medicine

Expression Dynamics of Integrin α2, α3, and αV Upon Osteogenic Differentiation of Human Mesenchymal Stem Cells - PubMed | National Institutes of Health | 6/11/2020

Clinical Pharmacology and Therapeutics, Kyung Hee University School of Medicine, Seoul, 02447, Korea. 3 Department of Nanobiomedical Science, BK21 PLUS NBM Global Research Center for Regenerative Medicine, College of Dentistry, Dankook University, Cheonan, 330-714, Korea. [email protected] 4 Department of Integrative Bioscience and Biotechnology, Institute of Anticancer Medicine Development, Sejong University, 209 Neungdong-ro, Gwangjin-gu, Seoul, 05006, Korea. [email protected] PMID: 32493499 Favorites Abstract Background: The differentiation of human …

COVID-19

The novel coronavirus attacks the lungs. A biotech company sees a common enzyme as key to protecting them | STAT | 6/10/2020

… just an entryway for infection, and scientists say the enzyme could point the way to a much-needed treatment for Covid-19. Constant Therapeutics, a privately held Boston biotech company with a small staff and … is the bad guy,” said Salvador Moncada, a professor of clinical pharmacology at the University of Manchester who specializes in inflammatory disease. advertisement For Concepción Peiró, a professor of pharmacology at the Autonomous University of …

American Heart Association

Healthy people shouldn’t take daily aspirin to prevent heart disease, review finds - CNN | 6/3/2020

… Clinical Pharmacology. The review, which focused on the risks and benefits of low-dose daily aspirin, found that the risk of a major bleeding event as a result of the drug’s blood-thinning effects outweighs the benefit. Daily aspirin to prevent heart attacks no longer recommended for older adults US guidance on a daily dose of aspirin changed last year, with the American College of Cardiology and the American Heart …

National Institutes of Health

Kriya Therapeutics announces $80 million Series A financing to advance gene therapies for highly prevalent serious diseases | PR Newswire | 5/12/2020

… manufacturing infrastructure – Partnerships in place with leading academic and research institutions, including Universitat Autònoma de Barcelona (UAB) and the U.S. National Institutes of Health (NIH) News provided by May 12, 2020, 07:45 ET Share this … Brian Furmanski , Ph.D. – Vice President of Regulatory Affairs . Former Senior Clinical Pharmacology Reviewer at the U.S. Food and Drug Administration (FDA) Nachi Gupta , M.D., Ph.D. – Chief of Staff . Board-Certified Emergency Medicine Physician “Kriya is …

NIH

Kriya Therapeutics announces $80 million Series A financing to advance gene therapies for highly prevalent serious diseases | PR Newswire | 5/12/2020

… place with leading academic and research institutions, including Universitat Autònoma de Barcelona (UAB) and the U.S. National Institutes of Health (NIH) News provided by May 12, 2020, 07:45 ET Share this article PALO ALTO, Calif … Brian Furmanski , Ph.D. – Vice President of Regulatory Affairs . Former Senior Clinical Pharmacology Reviewer at the U.S. Food and Drug Administration (FDA) Nachi Gupta , M.D., Ph.D. – Chief of Staff . Board-Certified Emergency Medicine Physician “Kriya is …

Clinical Data

Syapse, FDA, and Advocate Aurora Health to Present Pneumonitis Safety Data in Plenary Talk at AACR Virtual Meeting | Globe Newswire | 4/27/2020

… chemotherapy in clinical trials and real-world data ,” that highlights work conducted as a collaboration between Syapse, the Office of Clinical Pharmacology (OCP) within the FDA Center for Drug Evaluation and Research (CDER), and Advocate … multi-source approach to developing real-world evidence that combines clinical data from medical oncology outpatient clinics, hospital EHRs, non-oncology clinics, registries, and other sources across integrated health systems with molecular data from testing …

Precision Medicine

Syapse, FDA, and Advocate Aurora Health to Present Pneumonitis Safety Data in Plenary Talk at AACR Virtual Meeting | Globe Newswire | 4/27/2020

… chemotherapy in clinical trials and real-world data ,” that highlights work conducted as a collaboration between Syapse, the Office of Clinical Pharmacology (OCP) within the FDA Center for Drug Evaluation and Research (CDER), and Advocate … Phase Cancer Research Program and co-director of the Oncology Precision Medicine Program at Advocate Aurora Health. “This research provides encouraging new data that clinicians can use to better understand the post-approval behavior of …

AACR

Syapse, FDA, and Advocate Aurora Health to Present Pneumonitis Safety Data in Plenary Talk at AACR Virtual Meeting | 4/27/2020

… medical history of pneumonitis had a higher incidence of treatment associated pneumonitis in both clinical trial and real-world data AACR Virtual Annual Meeting Plenary Session April 27, 2020 at 4:00 PM EDT SAN FRANCISCO … work conducted as a collaboration between Syapse, the Office of Clinical Pharmacology (OCP) within the FDA Center for Drug Evaluation and Research (CDER), and Advocate Aurora Health. Results of this research will be presented by …

Patient Management

Prospective observational study on the pharmacokinetic properties of the Irrua ribavirin regimen used in routine clinical practice in patients with Lassa fever in Nigeria | BMJ | 4/17/2020

… Bernhard Nocht Institute for Tropical Medicine & I. Department of Medicine , University Medical Center Hamburg-Eppendorf , Hamburg , Germany 4 Department of Clinical Pharmacology , University of Hamburg , Hamburg , Germany 5 Department of Infectious Diseases and Pulmonary Medicine … a daily basis since 2008. An LF clinic for appropriate patient management was commissioned in 2010. Up to 2000 suspected patients are tested each year of which 100–200 test positive for LASV. Most of …

ISTH

Prospective observational study on the pharmacokinetic properties of the Irrua ribavirin regimen used in routine clinical practice in patients with Lassa fever in Nigeria | BMJ | 4/17/2020

… Bernhard Nocht Institute for Tropical Medicine & I. Department of Medicine , University Medical Center Hamburg-Eppendorf , Hamburg , Germany 4 Department of Clinical Pharmacology , University of Hamburg , Hamburg , Germany 5 Department of Infectious Diseases and Pulmonary Medicine … pharmacokinetic (PK) data are not available. Irrua Specialist Teaching Hospital (ISTH) developed an intravenous ribavirin regimen different to the WHO recommendation. Apart from a lower total daily dose the drug is usually administered once per …

Health Research

Therapeutic drug monitoring of voriconazole: validation of a high performance liquid chromatography method and comparison with an ARK immunoassay | BMJ | 3/9/2020

1 Pharmacy Department , Complejo Hospitalario Universitario de Santiago de Compostela , Santiago de Compostela , Spain 2 Department of Pharmacology, Pharmacy and Pharmaceutical Technology , University of Santiago de Compostela , Santiago de Compostela , Spain 3 Clinical Pharmacology Group , Health Research Institute of Santiago de Compostela (IDIS) , Santiago de Compostela , Spain 4 Pharmacy Department , Hospital General Universitario Castellon , Castellon , Castellon , Spain 5 Pharmacy Department , Hospital Sant Pau i Santa Tecla , Tarragona , Spain 6 Department …

American College of Rheumatology

RAYOS (prednisone) tablet, delayed release [Horizon Therapeutics USA, Inc.] | National Institutes of Health | 1/17/2020

… colloidal silicon dioxide, croscarmellose sodium, glycerol dibehenate, lactose monohydrate, magnesium stearate, povidone, yellow ferric oxide, and red ferric oxide. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Naturally occurring corticosteroids (hydrocortisone and cortisone), which also have … patients ≥18 years with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria. Patients were enrolled who were not currently treated with corticosteroids but had received non-biologic DMARD therapy for at …

Mental Health

HYSINGLA ER (hydrocodone bitartrate) tablet, extended release [Purdue Pharma LP] | National Institutes of Health | 1/14/2020

… half the initial dose of HYSINGLA ER in these patients and monitor closely for respiratory depression, sedation, and hypotension [see Clinical Pharmacology ( 12.3 )] . 2.5 Dosage Modifications in Patients with Moderate to Severe Renal Impairment Patients … pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper. A multimodal approach to pain management may optimize the treatment …

Medical Research

Neuropsychiatric events in systemic lupus erythematosus: a longitudinal analysis of outcomes in an international inception cohort using a multistate model approach | BMJ | 1/8/2020

Clinical Pharmacology , Oklahoma Medical Research Foundation , Oklahoma City , OK , USA 11 Division of Rheumatology, Department of Medicine , CHU de Québec, Université Laval , Quebec City , Quebec , Canada 12 Arthritis Research UK Epidemiology Unit, Faculty of Biology Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, and NIHR Manchester Musculoskeletal Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre , Manchester , UK 13 Department of Rheumatology …

Behavioral Health

The American College of Medical Toxicology Presents the 2020 Opioid Symposium and 2020 Annual Scientific Meeting in NYC on March 12-15 | PRWeb | 1/6/2020

… at Rutgers New Jersey Medical Center Point Counterpoint: We Should Curb Opioid Prescribing Andrew Kolodny, MD, Senior Scientist, Institute for Behavioral Health; Co-Director of Opioid Policy Research, Heller School for Social Policy and Management … Mount Sinai UK Novichok Attack Simon Thomas, MD, Professor of Clinical Pharmacology and Therapeutics, Newcastle University and NHS Foundation Trust, Newcastle, UK; and Stevan Emmett, MBChB, D.Phil, Principal Medical Officer and Senior Clinical Fellow, Defense …

Department of Health and Human Services

Scientific/Clinical Member Nominations Are Now Being Accepted for the HHS Panel on Antiretroviral Guidelines for Adults and Adolescents | National Institutes of Health | 1/2/2020

Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents (or the Panel) is accepting nominations for new scientific/clinical members with expertise in HIV medicine. The Panel is seeking candidates with expertise in: HIV clinical research and clinical care Clinical pharmacology (with emphasis on expertise in antiretroviral-related drug-drug interactions) Clinical nursing in HIV Panel members critically evaluate new information and prepare guideline …

Visual Field Testing

HYDROXYCHLOROQUINE SULFATE tablet, film coated [Aphena Pharma Solutions - Tennessee, LLC] | National Institutes of Health | 12/27/2019

Hydroxychloroquine sulfate is not effective against chloroquine-resistant strains of P. falciparum (see CLINICAL PHARMACOLOGY – Microbiology ). Ocular Irreversible retinal damage has been observed in some patients who had received hydroxychloroquine sulfate. Significant risk factors for … macula. In patients of Asian descent, it is recommended that visual field testing be performed in the central 24 degrees instead of the central 10 degrees. It is recommended that hydroxychloroquine be discontinued if ocular …

Smoking Cessation

BENAZEPRIL HYDROCHLORIDE tablet, coated [NuCare Pharmaceuticals,Inc.] | National Institutes of Health | 12/12/2019

… high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug … in pediatric patients 7 to 16 years of age [see Clinical Pharmacology ( 12.3 )]. The pharmacokinetics of benazepril hydrochloride have been evaluated in pediatric patients 6 to 16 years of age [see Clinical Pharmacology ( 12.3 )]. Infants …

AstraZeneca

ROSUVASTATIN CALCIUM tablet, film coated [NorthStar RxLLC] | National Institutes of Health | 7/22/2020

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric … 20 mg/day [see Use in Specific Populations ( 8.8 ) and Clinical Pharmacology ( 12.3 )]. 2.4 Use with Concomitant Therapy Patients taking cyclosporine and darolutamide The dose of rosuvastatin tablets should not exceed 5 mg once daily …

Merck

BRAVECTO (fluralaner) tablet, chewable [Merck Sharp & Dohme Corp.] | National Institutes of Health | 7/15/2020

Merck Animal Health at 1-800-224-5318. Additional information can be found at www.bravecto.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth. Clinical Pharmacology: Peak fluralaner concentrations are achieved between 2 hours and 3 days following oral administration, and the elimination half-life ranges between 9.3 to 16.2 days. Quantifiable drug concentrations can be measured (lower than necessary …

Bristol-Myers

Senior Pharmaceutical Drug Development Executive, Philip Chaikin, PharmD, MD, FCP, Joins NDA Partners as Expert Consultant | PRWeb | 6/17/2020

… today that Dr. Philip Chaikin, a senior pharmaceutical industry executive with extensive drug development experience in development strategy, regulatory strategy, clinical pharmacology, and clinical study design, has joined the firm as an Expert Consultant. Throughout … career, Dr. Chaikin served as Director of Clinical Pharmacology at Bristol-Myers Squibb, Senior Associate Medical Director at Pfizer, and Senior Research Scientist, Drug Metabolism and Pharmacokinetics at Ortho Pharmaceuticals. “We are pleased to welcome …

Bristol-Myers Squibb

Senior Pharmaceutical Drug Development Executive, Philip Chaikin, PharmD, MD, FCP, Joins NDA Partners as Expert Consultant | PRWeb | 6/17/2020

… today that Dr. Philip Chaikin, a senior pharmaceutical industry executive with extensive drug development experience in development strategy, regulatory strategy, clinical pharmacology, and clinical study design, has joined the firm as an Expert Consultant. Throughout … career, Dr. Chaikin served as Director of Clinical Pharmacology at Bristol-Myers Squibb, Senior Associate Medical Director at Pfizer, and Senior Research Scientist, Drug Metabolism and Pharmacokinetics at Ortho Pharmaceuticals. “We are pleased to welcome …

Gilead

Steroid drug hailed as ‘breakthrough’ for seriously ill COVID-19 patients | Yahoo News | 6/16/2020

… coronavirus, which has killed more than 431,000 people globally, has been shown to reduce the mortality of the disease, although Gilead Sciences Inc’s GILD.O remdesivir shortened the recovery time for hospital patients. “This blows remdesivir … the treatment into practice,” said Robin Ferner, honorary professor of clinical pharmacology at University of Birmingham. Dr. Thomas McGinn, deputy physician-in-chief at Northwell Health, New York’s largest healthcare system, told Reuters that physicians …

Celerion

The Future of Pharmacy: Celerion Expands Its Purpose-Built, USP-Compliant Pharmacy Capabilities Across Facilities | Business Wire | 6/4/2020

LINCOLN, Neb.- Celerion announced today the multimillion-dollar expansion of specialized pharmacies across their clinical research units in North America, demonstrating their commitment to further assisting sponsors in meeting the forthcoming USP requirements for compounding … upgrade of the pharmacy suites in the Phoenix and Lincoln clinical pharmacology units. “Celerion is proud to open these dedicated ISO classified areas for compounding nonhazardous and hazardous drugs for both sterile and non-sterile …

Merck & Co

DAPTOMYCIN injection, powder, lyophilized, for solution [BE Pharmaceuticals Inc.] | National Institutes of Health | 6/3/2020

… the one comparator-treated patient did not discontinue therapy [see Warnings and Precautions ( 5.2 )]. Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s … inhibitors) [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.3 )] Respiratory, Thoracic, and Mediastinal Disorders: cough, eosinophilic pneumonia, organizing pneumonia [see Warnings and Precautions ( 5.3 )] Nervous System Disorders: peripheral neuropathy [see Warnings …

Teva Pharmaceutical

Liquidia Appoints Tushar Shah, M.D., as Chief Medical Officer | Globe Newswire | 5/18/2020

… that this addition to our outstanding management team moves us closer to achieving our mission.” Dr. Shah joins Liquidia from Teva Pharmaceuticals, where he served as Head of Global Specialty Clinical Development with oversight of … position of U.S. Head, Respiratory and Inflammation, Discovery Medicine and Clinical Pharmacology with responsibility for early-stage clinical development of new therapies for the treatment of chronic obstructive pulmonary disease (COPD), asthma, and rhinitis. “I …

Teva Pharmaceutical

Liquidia Appoints Tushar Shah, M.D., as Chief Medical Officer | Globe Newswire | 5/18/2020

… that this addition to our outstanding management team moves us closer to achieving our mission.” Dr. Shah joins Liquidia from Teva Pharmaceuticals, where he served as Head of Global Specialty Clinical Development with oversight of … position of U.S. Head, Respiratory and Inflammation, Discovery Medicine and Clinical Pharmacology with responsibility for early-stage clinical development of new therapies for the treatment of chronic obstructive pulmonary disease (COPD), asthma, and rhinitis. “I …

Pfizer

Altimmune Appoints Former Pfizer and GSK Executive Diane Jorkasky, M.D. to its Board of Directors | Globe Newswire | 5/12/2020

Pfizer as its Vice President of Global Clinical Research Operations, where she was responsible for all exploratory development, clinical pharmacology and translational medicine. Of her many accomplishments, she led Pfizer’s international Clinical Research Units which received certification by American Accreditation for Human Rights Protection Policies for their clinical research process, the first in industry or academia to achieve such a recognition. Previously, Dr. Jorkasky was Vice President of Clinical Research …

Novo Nordisk

Basilea announces appointment of new Head of Global Quality Management | Globe Newswire | 4/29/2020

Novo Nordisk Health Care, Zurich, Switzerland, on February 1, 2020, as Head of Quality Compliance Systems & Safety. She holds a Master’s Degree in Clinical Pharmacology from the University of Aberdeen, United Kingdom, and a Master’s in Pharmacy from Nagpur University, India. At Novo Nordisk, Ms. Ram Moorthi served as Director Clinical Quality and Pharmacovigilance responsible for the oversight of Quality Management Reviews, clinical quality and pharmacovigilance for International Operations. Prior …

Sanofi Pasteur

MENQUADFI (neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen, neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen, neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugate antigen, and neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen) injection, solution [Sanofi Pasteur Inc.] | National Institutes of Health | 4/29/2020

… monitors pregnancy outcomes in women exposed to MenQuadfi during pregnancy. To enroll in or obtain information about the registry, call Sanofi Pasteur at 1-800-822-2463. Risk Summary All pregnancies have a risk of birth defect, loss … polyisoprene blend stopper (not made with natural rubber latex). 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Invasive meningococcal disease (IMD) is caused by the bacterium N. meningitidis , a gram-negative diplococcus found exclusively in humans …

GSK

PFIZER REPORTS FIRST-QUARTER 2020 RESULTS | Business Wire | 4/28/2020

… reported in Pfizer’s Upjohn business in all periods presented. Acquisitions and the contribution of Pfizer’s Consumer Healthcare business to the GSK Consumer Healthcare joint venture (JV) that were completed during 2019 impacted financial results in … COVID-19 mitigation efforts, Pfizer researchers published a review in Clinical Pharmacology and Therapeutics which assesses published in vitro and clinical data regarding azithromycin as an agent with antiviral properties. This open access review may …

Syapse

Syapse, FDA, and Advocate Aurora Health to Present Pneumonitis Safety Data in Plenary Talk at AACR Virtual Meeting | 4/27/2020

… AACR Virtual Annual Meeting Plenary Session April 27, 2020 at 4:00 PM EDT SAN FRANCISCO, April 27, 2020 (GLOBE NEWSWIRE) – Syapse announced that research results stemming from its Research Collaboration Agreement with the U.S. Food … work conducted as a collaboration between Syapse, the Office of Clinical Pharmacology (OCP) within the FDA Center for Drug Evaluation and Research (CDER), and Advocate Aurora Health. Results of this research will be presented by …

Biogen

X-Biotix Therapeutics Announces Appointment Of Michael W. Bonney to its Board of Directors | Business Wire | 4/21/2020

… Merck in early 2015 for $9.5 billion. Prior to Cubist, Mr. Bonney was vice president of sales and marketing at Biogen, where he built the company’s commercial infrastructure for the launch of its first product … Tesaro, SVP Regulatory Cubist, VP Regulatory Biogen Thomas Lodise, Ph.D. , Clinical Pharmacology Advisor - Clinical Pharmacist & Professor, Albany College of Pharmacy and Health Sciences Michael Pollastri, Ph.D. , Chemistry Advisor - Chair, Department of Chemistry & Chemical Biology, Northeastern …

Certara

Certara Launches COVID-19 Pharmacology Online Resource Center | Business Wire | 4/7/2020

Certara ®, the global leader in model-informed drug development, announced today that it has launched the COVID-19 Pharmacology Resource Center (the Center) to help advance therapeutics for COVID-19. The Center is an online resource that unites experts across the globe in accelerating efforts in the fight against COVID-19 by providing pharmacology simulation tools and a forum for scientific exchange. The Center emphasizes the importance of incorporating clinical …

Genzyme

Seres Therapeutics Appoints Lisa von Moltke, M.D., as Chief Medical Officer | Business Wire | 4/6/2020

… Chief Medical Officer. Dr. von Moltke joins Seres with an extensive career that includes senior leadership positions at Alkermes, Sanofi Genzyme and Millennium Pharmaceuticals/Takeda Oncology. This press release features multimedia. View the full release … She has served as President of the American College of Clinical Pharmacology and as the Editor-in-Chief of The Journal of Clinical Pharmacology . Dr. von Moltke earned her B.A. degree at Wellesley College and …

Sanofi Genzyme

Seres Therapeutics Appoints Lisa von Moltke, M.D., as Chief Medical Officer | Business Wire | 4/6/2020

… and Chief Medical Officer. Dr. von Moltke joins Seres with an extensive career that includes senior leadership positions at Alkermes, Sanofi Genzyme and Millennium Pharmaceuticals/Takeda Oncology. This press release features multimedia. View the full … She has served as President of the American College of Clinical Pharmacology and as the Editor-in-Chief of The Journal of Clinical Pharmacology . Dr. von Moltke earned her B.A. degree at Wellesley College and …

Johnson & Johnson

TB Alliance Names Dr. Daniel Everitt Vice President and Chief Medical Officer | PR Newswire | 2/12/2020

… Johnson & Johnson’s pharmaceutical sector, including as Vice President and Global Head of Clinical Pharmacology and Experimental Medicine at Johnson & Johnson Pharmaceutical Research and Development, and as Vice President of Safety Governance. He is an author or co-author of more than 50 publications in peer-reviewed journals in the fields of pharmacoepidemiology, clinical pharmacology and tuberculosis therapy. About TB Alliance TB Alliance is a not-for-profit organization dedicated to …

Gilead Sciences

(USA-CA-Foster City) Senior Research Associate I, Drug Metabolism (Biologics) | 12/1/2019

Gilead Sciences, Inc. Senior Research Associate I, Drug Metabolism (Biologics) in Foster City , California For Current Gilead Employees and Contractors: Please log onto your Internal Career Site at https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ … Pharmacokinetics group in research, working closely with biology, biochemistry, toxicology, clinical pharmacology, pharmaceutical sciences, and regulatory to optimize leads, to select candidates for clinical evaluation, and contribute to IND/IMPD and NDA/BLA filings. Specific …

Novartis

DEFERASIROX tablet, film coated [Cadila Healthcare Limited] | National Institutes of Health | 11/29/2019

… periods (IRR=1.91, 95% CI: 1.05 to 3.48) [see Warnings and Precautions ( 5.6 )]. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s JADENU ® (deferasirox) tablets. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights … simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, and vardenafil) [see Clinical Pharmacology ( 12.3 )]. 7.3 Agents Metabolized by CYP2C8 Deferasirox inhibits CYP2C8 resulting in an increase in CYP2C8 substrate (e.g., repaglinide and paclitaxel) concentration when these …

Sandoz

TELMISARTAN tablet [Sandoz Inc] | National Institutes of Health | 11/29/2019

… 4 to 8 hours after administration. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established [see Clinical Pharmacology ( 12.3 )] . Neonates with a history of in utero exposure to telmisartan. If oliguria … Manufactured by Lek Pharmaceuticals d.d., SI-1526 Ljubljana, Slovenia for Sandoz Inc., Princeton, NJ 08540 Product of China …

GlaxoSmithKline

$216.94 Billion Generic Pharmaceutical Market Size, Share, Manufacturers & 2022 Forecasts In Exclusive Report By TBRC | PR Newswire | 11/26/2019

… with branded drugs. For example, a research was conducted by Sahana K Hebbar in 2017 on International Journal of Basic & Clinical Pharmacology; out of 100 patients and 50 non-medical staff, 95% of the patients … different release dates, appearances and taste. For example, in 2017, GlaxoSmithKline (GSK) completed a study where ultraviolet (UV) and 3D printing technology were used to manufacture tablets to treat Parkinson’s disease. Martin Wallace , director of …

GE Healthcare

Clariscan (Gadoterate Meglumine Injection) - updated on RxList | 11/22/2019

… fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Report any diagnosis of NSF following Clariscan administration to GE Healthcare at (1-800-654-0118) or FDA at (1-800-FDA-1088 or www.fda.gov/medwatch ) . Screen patients … prevention of NSF is unknown [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY ]. Hypersensitivity Reactions Anaphylactic and anaphylactoid reactions have been reported with Clariscan, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse …

Genentech

Why Oncology Drugs are Projected to Generate the Largest Pharma Revenues | PR Newswire | 11/19/2019

… clinical pharmacology, immunogenicity, clinical efficacy, and safety data. In May 2019 , the FDA approved TRUXIMA to match all of the reference product’s oncology indications for NHL and CLL. In light of a patent settlement with Genentech, Celltrion and Teva have a pending FDA submission for rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA), and a license from Genentech to expand the TRUXIMA label to include these indications …

NCI

Bergenbio Announces First Patient Dosed in Recurrent Glioblastoma Investigator Sponsored Phase I/II Study Assessing Selective AXL Inhibitor Bemcentinib | PR Newswire | 7/20/2020

… co-leader of the Neuro-Oncology Program at University of Alabama at Birmingham and funded by the National Cancer Institute (NCI). This is an open label, multi-centre, intra-tumoral tissue pharmacokinetic (PK) study of … Prof. Jeff Supko , Harvard Medical School and Director of the Clinical Pharmacology Laboratory, Massachusetts General Hospital ( Boston , USA ). Prof. Burt Nabors MD, the Chairman of the trial and Director of Neuro-Oncology at University of …

EVEROLIMUS tablet [Teva Pharmaceuticals USA, Inc.] | National Institutes of Health | 6/11/2020

Grading according to NCI CTCAE Version 3.0. a No Grade 4 laboratory abnormalities were reported. Updated safety information from 111 patients treated with everolimus for a median duration of 47 months identified the following additional … gp and strong CYP3A4 inhibitors [see Dosage and Administration ( 2.11 ), Clinical Pharmacology ( 12.3 )] . Reduce the dose for patients taking everolimus with a P-gp and moderate CYP3A4 inhibitor as recommended [see Dosage and Administration ( 2.11 …

Bill & Melinda Gates Foundation

Certara Launches COVID-19 Pharmacology Online Resource Center | Business Wire | 4/7/2020

clinical pharmacology and translational medicine principles to optimize dosing in clinical studies. The Center, funded by the Bill & Melinda Gates Foundation, is designed to aid scientists in determining the optimal dose of therapeutics that are being evaluated in COVID-19 clinical studies, such as hydroxychloroquine and lopinavir/ritonavir. Dosing is a critical decision in testing potential therapeutics for COVID-19 because drugs affect patients differently. The dose has to be …

Certara Launches COVID-19 Pharmacology Online Resource Center | Business Wire | 4/7/2020

clinical pharmacology and translational medicine principles to optimize dosing in clinical studies. The Center, funded by the Bill & Melinda Gates Foundation, is designed to aid scientists in determining the optimal dose of therapeutics that are being evaluated in COVID-19 clinical studies, such as hydroxychloroquine and lopinavir/ritonavir. Dosing is a critical decision in testing potential therapeutics for COVID-19 because drugs affect patients differently. The dose has to be …

Alkermes

Seres Therapeutics Appoints Lisa von Moltke, M.D., as Chief Medical Officer | Business Wire | 4/6/2020

… President and Chief Medical Officer. Dr. von Moltke joins Seres with an extensive career that includes senior leadership positions at Alkermes, Sanofi Genzyme and Millennium Pharmaceuticals/Takeda Oncology. This press release features multimedia. View the … She has served as President of the American College of Clinical Pharmacology and as the Editor-in-Chief of The Journal of Clinical Pharmacology . Dr. von Moltke earned her B.A. degree at Wellesley College and …

Seres Therapeutics Appoints Lisa von Moltke, M.D., as Chief Medical Officer | Business Wire | 4/6/2020

… President and Chief Medical Officer. Dr. von Moltke joins Seres with an extensive career that includes senior leadership positions at Alkermes, Sanofi Genzyme and Millennium Pharmaceuticals/Takeda Oncology. This press release features multimedia. View the … She has served as President of the American College of Clinical Pharmacology and as the Editor-in-Chief of The Journal of Clinical Pharmacology . Dr. von Moltke earned her B.A. degree at Wellesley College and …

Citigroup

Amgen Inc. (AMGN) CEO Bob Bradway on Q3 2019 Results - Earnings Call Transcript | Seeking Alpha | 10/30/2019

… Stanley Geoffrey Porges - Leerink Partners Umer Raffat - Evercore ISI Salim Syed - Mizuho Jay Olson - Oppenheimer Cory Kasimov - JPMorgan Mohit Bansal - Citigroup Kennen MacKay - RBC Capital Markets Operator My name is Ian, and I will be … schedules and we will do that as part of the clinical pharmacology program going forward, including split dosing such as BID. And then finally, as you noted the field is exploding. That’s a fact that …

Reata Pharmaceuticals, Inc. (RETA) CEO Warren Huff on Q1 2019 Results - Earnings Call Transcript | Seeking Alpha | 5/9/2019

… Company Participants Vinny Jindal - VP, Strategy Warren Huff - CEO Colin Meyer - CMO Jason Wilson - CFO Conference Call Participants Yigal Nochomovitz - Citigroup Adam Walsh - Stifel Joseph Swartz - SVP Leerink Maury Raycroft - Jefferies Brian Skorney - Baird Operator … has indicated that we’ve conducted all preclinical toxicology studies and clinical pharmacology studies required for NDA submission. We are making significant investments in supply chain readiness. We put our marketing and commercial operations and sales …

SunTrust Robinson Humphrey

Verona Pharma plc (VRNA) CEO Jan-Anders Karlsson on Q1 2019 Results - Earnings Call Transcript | Seeking Alpha | 5/13/2019

… Relations Jan-Anders Karlsson - Chief Executive Officer Piers Morgan - Chief Financial Officer Conference Call Participants Lucy Codrington - Jefferies Joon Lee - SunTrust Robinson Humphrey Liana Moussatos - Wedbush Securities Tom Shrader - BTIG Patrick Trucchio - Berenberg Capital Markets … that’s the major difference because the issue in the first clinical pharmacology study was asking the question is there room for improvement in patients already on maximum bronchodilator therapy. And I think we answered that …

Eloxx Pharmaceuticals’ (ELOX) CEO Robert Ward on Q1 2019 Results - Earnings Call Transcript | Seeking Alpha | 5/11/2019

… Chief Financial Officer David Snow – Chief Business Officer Conference Call Participants Joel Beatty – Citi Ted Tenthoff – Piper Jaffray Fang-Ke – SunTrust Robinson Humphrey Operator Good morning, everyone, and welcome to Eloxx Pharmaceuticals’ First Quarter 2019 … Phase 1 SAD study were published in the Journal of Clinical Pharmacology and Drug Development in January, and the emerging profile supports our continuing development program. We previously announced that we were adding additional cohorts …

Massachusetts General Hospital

Bergenbio Announces First Patient Dosed in Recurrent Glioblastoma Investigator Sponsored Phase I/II Study Assessing Selective AXL Inhibitor Bemcentinib | PR Newswire | 7/20/2020

Clinical Pharmacology Laboratory, Massachusetts General Hospital ( Boston , USA ). Prof. Burt Nabors MD, the Chairman of the trial and Director of Neuro-Oncology at University of Alabama at Birmingham (UAB) and Director of UAB’s Centre for Clinical Translational Science’s Clinical Research Unit, commented: “GBM is among the most lethal of adult cancers. The median survival of patients remains less than two years despite the current available therapies, including surgery, radiation, and …

Author Correction: On-chip recapitulation of clinical bone marrow toxicities and patient-specific pathophysiology | Nature | 2/12/2020

Department of Pathology, Massachusetts General Hospital, Boston, MA, USA David B. Chou Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK Rhiannon David DMPK, Oncology R&D, AstraZeneca, Boston, MA, USA Petar Pop-Damkov & Douglas Ferguson Clinical and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, Pharmaceutical Sciences, R&D, AstraZeneca, Cambridge, UK Alexander MacDonald Dana Farber/Boston Children’s Cancer and Blood Disorders Center, Boston, MA, USA Özge Vargel …

University Hospital

Eikonizo Therapeutics Announces Publication of the First-in-Human Study of [18F]EKZ-001 and Expansion of Leadership Team, Adding Extensive Experience in Preclinical and Clinical Development | Business Wire | 7/8/2020

… including amyotrophic lateral sclerosis and Alzheimer’s disease, making [18F]EKZ-001 a valuable research tool. The study was performed at University Hospitals Leuven in Belgium and co-led by Koen Van Laere, MD, PhD, Jan … Plough/Merck and i3 Research, brings decades of experience in clinical pharmacology, CNS clinical trial design and execution, molecular imaging and fluid biomarkers. Dr. Hickman has supported drug discovery, development, and post marketing efforts in …

Covid-19: Number of Germans infected could be 10 times higher than official estimates | BMJ | 5/7/2020

University Hospital Bonn, and Gunther Hartmann, director of the Institute for Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn, randomly selected 600 households in Gangelt and wrote letters asking them to participate in the study. Some 919 people from 405 households were interviewed and tested from 30 March until 6 April. Researchers took throat swabs and performed both polymerase chain reaction (PCR) and enzyme linked immunosorbent assay (ELISA) tests …

Medical Center

Clinical Trial Outcomes of Recardio’s Dutogliptin Published in the British Journal of Pharmacology | PR Newswire | 5/18/2020

… ct2/show/NCT03486080 Dr. Roman Schenk , Executive Chairman of Recardio, expressed his gratitude on behalf of the company to Professor Bernd Jilma , the study’s principal investigator, and his teams at the Department of Clinical Pharmacology and the Center for Medical Statistics at the University of Vienna, Austria . About Recardio Recardio Inc. is a clinical-stage life science company focusing on therapies for cardiovascular, oncology and infectious diseases. The company’s lead …

Prospective observational study on the pharmacokinetic properties of the Irrua ribavirin regimen used in routine clinical practice in patients with Lassa fever in Nigeria | BMJ | 4/17/2020

Medical Center Hamburg-Eppendorf , Hamburg , Germany 4 Department of Clinical Pharmacology , University of Hamburg , Hamburg , Germany 5 Department of Infectious Diseases and Pulmonary Medicine , Charité Universitätsmedizin Berlin , Berlin , Germany 6 Department of Virology , Bernhard-Nocht-Institut fur Tropenmedizin , Hamburg , Germany 7 Department of Obstetrics and Gynaecology , Irrua Specialist Teaching Hospital , Irrua , Nigeria Correspondence to Dr Mirjam Groger; groger(at)bnitm.de Abstract Introduction Lassa fever (LF) is a severe and often …

University Medical Center

Prospective observational study on the pharmacokinetic properties of the Irrua ribavirin regimen used in routine clinical practice in patients with Lassa fever in Nigeria | BMJ | 4/17/2020

University Medical Center Hamburg-Eppendorf , Hamburg , Germany 4 Department of Clinical Pharmacology , University of Hamburg , Hamburg , Germany 5 Department of Infectious Diseases and Pulmonary Medicine , Charité Universitätsmedizin Berlin , Berlin , Germany 6 Department of Virology , Bernhard-Nocht-Institut fur Tropenmedizin , Hamburg , Germany 7 Department of Obstetrics and Gynaecology , Irrua Specialist Teaching Hospital , Irrua , Nigeria Correspondence to Dr Mirjam Groger; groger(at)bnitm.de Abstract Introduction Lassa fever (LF) is a severe and …

Prospective observational study on the pharmacokinetic properties of the Irrua ribavirin regimen used in routine clinical practice in patients with Lassa fever in Nigeria | BMJ | 4/17/2020

University Medical Center Hamburg-Eppendorf , Hamburg , Germany 4 Department of Clinical Pharmacology , University of Hamburg , Hamburg , Germany 5 Department of Infectious Diseases and Pulmonary Medicine , Charité Universitätsmedizin Berlin , Berlin , Germany 6 Department of Virology , Bernhard-Nocht-Institut fur Tropenmedizin , Hamburg , Germany 7 Department of Obstetrics and Gynaecology , Irrua Specialist Teaching Hospital , Irrua , Nigeria Correspondence to Dr Mirjam Groger; groger(at)bnitm.de Abstract Introduction Lassa fever (LF) is a severe and …

Johns Hopkins University School of Medicine

Neuropsychiatric events in systemic lupus erythematosus: a longitudinal analysis of outcomes in an international inception cohort using a multistate model approach | BMJ | 2/12/2020

… UCLA , Los Angeles , CA , USA 9 Centre for Rheumatology Research, Department of Medicine, University College , London , UK 10 Department of Clinical Pharmacology , Oklahoma Medical Research Foundation , Oklahoma City , OK , USA 11 Division of Rheumatology, Department … Academic Health Science Centre , Manchester , UK 13 Department of Rheumatology , Johns Hopkins University School of Medicine , Baltimore , MD , USA 14 Department of Medicine , SUNY Downstate Medical Center , Brooklyn , NY , USA 15 Thurston Arthritis Research Centre …

Emulate Publishes Results for Intestine-Chip Populated with Organoids; Data Demonstrates Superior Human-relevant Intestine Function than Organoids Alone | Business & Finance | manchestertimes.com | Business Wire | 1/14/2020

BOSTON–(BUSINESS WIRE)–Jan 14, 2020– Emulate, Inc. announced today a published study in collaboration with Johns Hopkins University School of Medicine, that demonstrated superior functionality of the Duodenum Intestine-Chip populated with organoids, compared … of personalized medicine. Applications include personalized preclinical testing and personalized clinical pharmacology to assess a range of measures, including: inter-individual differences in drug disposition and responses, studies of the effect of genetic polymorphisms on …

Mayo Clinic

November 2019 Briefing | 12/2/2019

… for developing diabetes and skin and soft tissue infections (SSTIs), published in the November issue of the British Journal of Clinical Pharmacology . Abstract/Full Text (subscription or payment may be required) Rates of Joint Surgery … the odds of burnout, published online Nov. 14 in the Mayo Clinic Proceedings . Abstract/Full Text Hypertension During Pregnancy May Up CV Risk in Middle Age FRIDAY, Nov. 22, 2019 – Hypertension during pregnancy heightens women’s …

November 2019 Briefing – Diabetes & Endocrinology | 12/2/2019

… skin and soft tissue infections (SSTIs), according to a study published in the November issue of the British Journal of Clinical Pharmacology . Abstract/Full Text (subscription or payment may be required) Most Teens Worldwide Are … according to a study published online Nov. 14 in the Mayo Clinic Proceedings . Abstract/Full Text Testosterone Replacement May Benefit Younger Male Cancer Survivors FRIDAY, Nov. 22, 2019 (HealthDay News) — Testosterone replacement is associated with …

Indiana University School of Medicine

Nationally Recognized Medical Experts Join Receptor Life Science’s Scientific Advisory Board to Guide the Development of New Cannabinoid Therapies | Markets Insider | Business Insider | 6/24/2019

… international experts in epilepsy, pain management, migraine, anxiety, post-traumatic stress disorder (PTSD), autism spectrum disorder, child psychiatry, sleep disorders, clinical pharmacology and clinical trials. “The Receptor Life Sciences Scientific Advisory Board includes some of … National Collegiate Athletic Association, and Clinical Professor of Neurology at Indiana University School of Medicine and NYU School of Medicine. He is an expert in pain management, concussion and sports medicine. Richard B. Lipton, MD …

Nationally Recognized Medical Experts Join Receptor Life Science’s Scientific Advisory Board to Guide the Development of New Cannabinoid Therapies | Globe Newswire | 6/24/2019

… international experts in epilepsy, pain management, migraine, anxiety, post-traumatic stress disorder (PTSD), autism spectrum disorder, child psychiatry, sleep disorders, clinical pharmacology and clinical trials. “The Receptor Life Sciences Scientific Advisory Board includes some of … National Collegiate Athletic Association, and Clinical Professor of Neurology at Indiana University School of Medicine and NYU School of Medicine. He is an expert in pain management, concussion and sports medicine. Richard B. Lipton, MD …

Stanford University Medical Center

CellSight Technologies Announces Strategic Collaboration With Boehringer Ingelheim to Develop a New Technology for Monitoring Anti-tumor T-Cell Activation | PR Newswire | 11/8/2017

… T cell activation and expansion in the tumor and its microenvironment. The trial is currently open for recruitment at the Stanford University Medical Center and is led by Dimitrios Colevas M.D ., John Sunwoo M.D ., Quynh … informed decisions.” Prof. Florian Gantner Head of Translational Medicine and Clinical Pharmacology at Boehringer Ingelheim: “ We are very excited to collaborate with CellSight Technologies, to provide a novel diagnostic tool for patients and doctors to …

CellSight Technologies Announces Strategic Collaboration With Boehringer Ingelheim to Develop a New | PR Newswire | 11/8/2017

… T cell activation and expansion in the tumor and its microenvironment. The trial is currently open for recruitment at the Stanford University Medical Center and is led by Dimitrios Colevas M.D ., John Sunwoo M.D ., Quynh … informed decisions.” Prof. Florian Gantner Head of Translational Medicine and Clinical Pharmacology at Boehringer Ingelheim: “ We are very excited to collaborate with CellSight Technologies, to provide a novel diagnostic tool for patients and doctors to …

Carl Peck

Senior Pharmaceutical Drug Development Executive, Philip Chaikin, PharmD, MD, FCP, Joins NDA Partners as Expert Consultant | PRWeb | 6/17/2020

Senior Pharmaceutical Drug Development Executive, Philip Chaikin, PharmD, MD, FCP, Joins NDA Partners as Expert Consultant Share Article NDA Partners Chairman Carl Peck, MD, announced today that Dr. Philip Chaikin, a senior pharmaceutical industry executive with extensive drug development experience in development strategy, regulatory strategy, clinical pharmacology, and clinical study design, has joined the firm as an Expert Consultant. Throughout his accomplished 30 year career, Dr. Chaikin secured numerous global …

Internationally Recognized Healthcare Executive, Diane Jorkasky, MD, FACP, Joins NDA Partners | PRWeb | 12/11/2019

NDA Partners Chairman Carl Peck, MD , announced today that Diane Jorkasky, MD, FACP , an internationally recognized clinical pharmacologist, drug development scientist, and healthcare executive with global medical and scientific leadership experience in the pharmaceutical and … of Development, Head of Worldwide Clinical Research Operations, Global Leader Clinical Pharmacology and Clinical Research Units, Global Clinical Sciences Leader, and Vice President of Clinical Sciences. In an earlier role, she served as Vice President …

Melinda Gates

Certara Launches COVID-19 Pharmacology Online Resource Center | Business Wire | 4/7/2020

clinical pharmacology and translational medicine principles to optimize dosing in clinical studies. The Center, funded by the Bill & Melinda Gates Foundation, is designed to aid scientists in determining the optimal dose of therapeutics that are being evaluated in COVID-19 clinical studies, such as hydroxychloroquine and lopinavir/ritonavir. Dosing is a critical decision in testing potential therapeutics for COVID-19 because drugs affect patients differently. The dose has to be …

Certara Launches COVID-19 Pharmacology Online Resource Center | Business Wire | 4/7/2020

clinical pharmacology and translational medicine principles to optimize dosing in clinical studies. The Center, funded by the Bill & Melinda Gates Foundation, is designed to aid scientists in determining the optimal dose of therapeutics that are being evaluated in COVID-19 clinical studies, such as hydroxychloroquine and lopinavir/ritonavir. Dosing is a critical decision in testing potential therapeutics for COVID-19 because drugs affect patients differently. The dose has to be …

Eric Shaff

Seres Therapeutics Appoints Lisa von Moltke, M.D., as Chief Medical Officer | Business Wire | 4/6/2020

… important period ahead of our anticipated SER-109 ECOSPOR III Phase 3 clinical readout in recurrent C. difficile infection,” said Eric Shaff, President and Chief Executive Officer of Seres. “Seres will benefit from Lisa’s extensive … She has served as President of the American College of Clinical Pharmacology and as the Editor-in-Chief of The Journal of Clinical Pharmacology . Dr. von Moltke earned her B.A. degree at Wellesley College and …

Seres Therapeutics Appoints Lisa von Moltke, M.D., as Chief Medical Officer | Business Wire | 4/6/2020

… important period ahead of our anticipated SER-109 ECOSPOR III Phase 3 clinical readout in recurrent C. difficile infection,” said Eric Shaff, President and Chief Executive Officer of Seres. “Seres will benefit from Lisa’s extensive … She has served as President of the American College of Clinical Pharmacology and as the Editor-in-Chief of The Journal of Clinical Pharmacology . Dr. von Moltke earned her B.A. degree at Wellesley College and …

David Geffen

Neuropsychiatric events in systemic lupus erythematosus: a longitudinal analysis of outcomes in an international inception cohort using a multistate model approach | BMJ | 2/12/2020

David Geffen School of Medicine at UCLA , Los Angeles , CA , USA 9 Centre for Rheumatology Research, Department of Medicine, University College , London , UK 10 Department of Clinical Pharmacology , Oklahoma Medical Research Foundation , Oklahoma City , OK , USA 11 Division of Rheumatology, Department of Medicine , CHU de Québec, Université Laval , Quebec City , Quebec , Canada 12 Arthritis Research UK Epidemiology Unit, Faculty of Biology Medicine and Health, Manchester Academic Health Sciences Centre, The …

Neuropsychiatric events in systemic lupus erythematosus: a longitudinal analysis of outcomes in an international inception cohort using a multistate model approach | BMJ | 1/8/2020

David Geffen School of Medicine at UCLA , Los Angeles , CA , USA 9 Centre for Rheumatology Research, Department of Medicine, University College , London , UK 10 Department of Clinical Pharmacology , Oklahoma Medical Research Foundation , Oklahoma City , OK , USA 11 Division of Rheumatology, Department of Medicine , CHU de Québec, Université Laval , Quebec City , Quebec , Canada 12 Arthritis Research UK Epidemiology Unit, Faculty of Biology Medicine and Health, Manchester Academic Health Sciences Centre, The …

John Burke

Applied BioMath, LLC to Hold Fourth Annual Quantitative Systems Pharmacology (QSP) Summit in Cambridge, MA | PR Newswire | 1/8/2020

… Clinical Pharmacology, CSL Behring Simon Zhou , PhD, Executive Director, Clinical Pharmacology and Translational Development, Celgene “We are excited to host the QSP Summit for the fourth time this year,” said John Burke , PhD, Co-founder, President and CEO, Applied BioMath. “Year over year we see growth at this event from the number of attendees, speakers, and poster presentations. We look forward to another great event this year; bringing industry and …

Applied BioMath, LLC and CytomX Therapeutics, Inc. Announce a Continuation of their Collaboration for Quantitative Systems Pharmacology Modeling in lmmuno-Oncology | PR Newswire | 10/23/2017

… used for internal decision making as well as to enable productive interactions with regulatory agencies,” said Mark Stroh , Senior Director, Clinical Pharmacology, at CytomX Therapeutics, Inc. Applied BioMath previously built models of CytomX’s Probody platform … the therapeutic as well as the disease biology,” said Dr. John Burke , PhD, Co-Founder, President, and CEO of Applied BioMath. “Because of this, our models translate well from in vitro to preclinical and into …

Earle Martin

Internationally Recognized Healthcare Executive, Diane Jorkasky, MD, FACP, Joins NDA Partners | PRWeb | 12/11/2019

… served in senior leadership roles at Pfizer as Vice President of Development, Head of Worldwide Clinical Research Operations, Global Leader Clinical Pharmacology and Clinical Research Units, Global Clinical Sciences Leader, and Vice President of Clinical … teams, and contract management of client product development programs. Contact Earle Martin, Chief Executive Officer Office: 540-738-2550 [email protected]

Internationally Recognized Healthcare Executive, Diane Jorkasky, MD, FACP, Joins NDA Partners | Markets Insider | Business Insider | 12/11/2019

… served in senior leadership roles at Pfizer as Vice President of Development, Head of Worldwide Clinical Research Operations, Global Leader Clinical Pharmacology and Clinical Research Units, Global Clinical Sciences Leader, and Vice President of Clinical … teams, and contract management of client product development programs. Contact Earle Martin , Chief Executive Officer Office: 540-738-2550 [email protected] SOURCE NDA Partners LLC …

Briggs W. Morrison

Syndax Pharmaceuticals Reports Third Quarter 2017 Financial Results and Provides Clinical and Business Update | PR Newswire | 11/7/2017

… throughout the year continues to yield meaningful progress and growth for our pipeline of potential best-in-class candidates,” said Briggs W. Morrison , M.D., Chief Executive Officer of Syndax. “The recent expansion of our pipeline … and ENCORE 603, costs related to SNDX-6352, Phase 1 clinical pharmacology trials and CMC activities. The increase in employee compensation costs was primarily due to increased headcount. General and administrative expenses totaled $3.6 million …

Syndax Pharmaceuticals Reports Third Quarter 2017 Financial Results and Provides Clinical and | PR Newswire | 11/7/2017

… throughout the year continues to yield meaningful progress and growth for our pipeline of potential best-in-class candidates,” said Briggs W. Morrison , M.D., Chief Executive Officer of Syndax. “The recent expansion of our pipeline … and ENCORE 603, costs related to SNDX-6352, Phase 1 clinical pharmacology trials and CMC activities. The increase in employee compensation costs was primarily due to increased headcount. General and administrative expenses totaled $3.6 million …

Timothy Tracy

Aprecia Pharmaceuticals Names University of Kentucky Provost as the Company’s Next CEO | PR Newswire | 11/1/2017

Aprecia Pharmaceuticals Names University of Kentucky Provost as the Company’s Next CEO Dr. Timothy Tracy to lead the firm in expanding its innovative, 3DP technology platform News provided by Nov 01, 2017, 10:22 CINCINNATI , Nov … the American Association of Pharmaceutical Scientists and an expert in clinical pharmacology, brings extensive technical skills to Aprecia. He also brings to the company significant leadership competencies, having held numerous key positions at state universities …

Aprecia Pharmaceuticals Names University of Kentucky Provost as the Company’s Next CEO | PR Newswire | 11/1/2017

CINCINNATI , Nov. 1, 2017 /PRNewswire/ – Aprecia Pharmaceuticals announced today that Dr. Timothy Tracy will serve as the company’s next Chief Executive Officer, beginning in January 2018. Dr. Tracy currently serves as the Provost for the University of Kentucky , a position he will maintain through the end of 2017. Tracy, a Fellow with the American Association of Pharmaceutical Scientists and an expert in clinical pharmacology, brings extensive technical skills to Aprecia …

State of Minnesota

Anastrozole has an Association between Degree of Estrogen Suppression and Outcomes in Early Breast Cancer and is a Ligand for Estrogen Receptor (alpha) | 6/15/2020

… Clinical Pharmacology, Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, Minnesota. 13 Division of Oncology Research, Mayo Clinic, Rochester, Minnesota. PDF Abstract Purpose: To determine if the degree of estrogen suppression with aromatase inhibitors (AI: anastrozole, exemestane, letrozole) is associated with efficacy in early-stage breast cancer, and to examine for differences in the mechanism of action between the three AIs. Experimental Design: Matched case–control studies [247 …

A Message from UW Health Sciences Deans | 5/31/2020

… PhD in pharmacokinetics from the University of Manchester. following a period at the University of Washington, he founded Medeval, a clinical pharmacology CRO, which was acquired by ICON in 2003. He has published over 50 … in the department of medicinal chemistry at the University of Minnesota College of Pharmacy. He is well known as a collaborative investigator in drug metabolism research, with an emphasis on glucuronidation. His research has included …

State of California

[ASAP] Long-Acting Human Growth Hormone Receptor Antagonists Produced in E. coli and Conjugated with Polyethylene Glycol | 6/4/2020

… California, Los Angeles, 607 Charles E. Young Drive East, Los Angeles, California 90095-1569, United States Stephen M. Jamieson Stephen M. Jamieson Department of Pharmacology and Clinical Pharmacology, School of Medical Sciences, University of Auckland, Auckland 1023, New Zealand Maurice Wilkins Centre for Molecular Biodiscovery, Auckland 1023, New Zealand Auckland Cancer Society Research Centre, School of Medical Sciences, University of Auckland, Auckland 1023, New Zealand Heather D. Maynard Heather D. Maynard …

A Message from UW Health Sciences Deans | 5/31/2020

… PhD in pharmacokinetics from the University of Manchester. following a period at the University of Washington, he founded Medeval, a clinical pharmacology CRO, which was acquired by ICON in 2003. He has published over 50 … at Pfizer Global Research and Development (PGRD) in La Jolla, California (1996 to 2002). Thereafter until present time she has led a group at Genomics Institute of Novartis Research Foundation (GNF), supporting in vitro and …

State of Washington

A Message from UW Health Sciences Deans | 5/31/2020

University of Washington University of Washington School of Public Health Edwina S. Uehara, PhD, MSW Professor and Ballmer Endowed Dean in Social Work University of Washington School of Social Work Azita Emami, PhD, MSN, BSN … period at the University of Washington, he founded Medeval, a clinical pharmacology CRO, which was acquired by ICON in 2003. He has published over 50 articles, abstracts and chapters in books. × Mingshe Zhu Ph.D. Medicinal …

Hydroxychloroquine and coronavirus: Everything to know about the drug Trump says he’s taking - News - telegram.com - Worcester, MA | Star Telegram | 5/20/2020

… breathing and increased incidence of cardiac arrhythmia,” said John Scott, chair of the department of pharmacology at the University of Washington School of Medicine. The long list of common side effects of Plaquenil (hydroxychloroquine) include … question,” said Mahmoud Al-Kofahi, a professor of experimental and clinical pharmacology at the University of Minnesota. Can I take it? Can my doctor prescribe it? It is not available over the counter at drug …

Boston, Massachusetts

The novel coronavirus attacks the lungs. A biotech company sees a common enzyme as key to protecting them | STAT | 6/10/2020

… say the enzyme could point the way to a much-needed treatment for Covid-19. Constant Therapeutics, a privately held Boston biotech company with a small staff and a threadbare website , hopes it might have … is the bad guy,” said Salvador Moncada, a professor of clinical pharmacology at the University of Manchester who specializes in inflammatory disease. advertisement For Concepción Peiró, a professor of pharmacology at the Autonomous University of …

Shift From Adalimumab Originator to Biosimilars in Denmark | 6/1/2020

March 30, 2020 Shift From Adalimumab Originator to Biosimilars in Denmark 1 Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark 2 Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, Massachusetts 3 Amgros, Copenhagen, Denmark Full Text Brand-name adalimumab (Humira, hereinafter originator ) is by far the most cost-intensive pharmaceutical product in the US with global sales of $19.9 billion in 2018. 1 Five adalimumab biosimilars …