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Getting the Dose Right in Drug Development for Rare Diseases: Barriers and Enablers.

Autor: Ahmed MA; Quantitative Clinical Pharmacology, Takeda Development Center, Cambridge, Massachusetts, USA., Krishna R; Certara Drug Development Solutions, Certara USA, Inc., Princeton, New Jersey, USA., Rayad N; Parexel International (MA) Corporation, Mississauga, ON, Canada.; Present address: Clinical Pharmacology and Safety Sciences, Alexion, AstraZeneca Rare Disease, Mississauga, ON, Canada., Albusaysi S; Department of Pharmaceutics, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia., Mitra A; Clinical Pharmacology, Kura Oncology Inc, Boston, Massachusetts, USA., Shang E; Global Regulatory Affairs and Clinical Safety, Merck &Co., Inc., Rahway, New Jersey, USA., Hon YY; Divsion of Rare Diseases and Medical Genetics, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, US Food and Drug Administration, Silver Spring, Maryland, USA., AbuAsal B; Division of Translational and Precision Medicine, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, Maryland, USA., Bakhaidar R; Department of Pharmaceutics, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia., Roman YM; Division of Translational and Precision Medicine, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, Maryland, USA., Bhattacharya I; Quantitative Clinical Pharmacology, Takeda Development Center, Cambridge, Massachusetts, USA., Cloyd J; Center for Orphan Drug Research, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, USA., Patel M; Quantitative Clinical Pharmacology, Takeda Development Center, Cambridge, Massachusetts, USA., Kartha RV; Center for Orphan Drug Research, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, USA., Younis IR; Quantitative Pharmacology and Pharmacometrics, Merck & Co., Inc., Rahway, New Jersey, USA.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Dec; Vol. 116 (6), pp. 1412-1432. Date of Electronic Publication: 2024 Aug 16.

An IQ Industry Perspective on Informing Dosing Recommendations in Patients With Renal Impairment.

Autor: Sharma A; Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA., Younis IR; Merck and Co., LLC, Rahway, New Jersey, USA., Kanodia J; Xencor Inc, Pasadena, California, USA., Sahasrabudhe V; Pfizer, Inc., Groton, Connecticut, USA.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Oct 22. Date of Electronic Publication: 2024 Oct 22.

Pharmacokinetics and Safety of Firsocostat, an Acetyl-Coenzyme A Carboxylase Inhibitor, in Participants with Mild, Moderate, and Severe Hepatic Impairment.

Autor: Younis IR; Gilead Sciences Inc, Foster City, California, USA., Nelson C; Gilead Sciences Inc, Foster City, California, USA., Weber EJ; Gilead Sciences Inc, Foster City, California, USA., Qin AR; Gilead Sciences Inc, Foster City, California, USA., Watkins TR; Gilead Sciences Inc, Foster City, California, USA., Othman AA; Gilead Sciences Inc, Foster City, California, USA.

Publikováno v: Journal of clinical pharmacology [J Clin Pharmacol] 2024 Jul; Vol. 64 (7), pp. 878-886. Date of Electronic Publication: 2024 Mar 22.

Evaluation of the Effects of Meal Type and Acid-Reducing Agents on the Pharmacokinetics of Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor Agonist.

Autor: Weber EJ; Gilead Sciences, Inc., Foster City, CA, USA., Younis IR; Gilead Sciences, Inc., Foster City, CA, USA., Wang L; Gilead Sciences, Inc., Foster City, CA, USA., Xiao D; Gilead Sciences, Inc., Foster City, CA, USA., Barchuk WT; Gilead Sciences, Inc., Foster City, CA, USA., Othman AA; Gilead Sciences, Inc., Foster City, CA, USA.

Publikováno v: Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2024 Jun; Vol. 13 (6), pp. 677-687. Date of Electronic Publication: 2024 Feb 12.