The Pharmacokinetics, Metabolism, and Clearance Mechanisms of Ritlecitinib, a Janus Kinase 3 and Tyrosine-Protein Kinase Family Inhibitor, in Humans.

Autor: Bauman JN; Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc., Cambridge, Massachusetts (M.E.D.) andGroton, Connecticut (J.N.B., A.C.D., G.M.G., B.H., T.S., M.A.C.); Clinical Pharmacology, Pfizer, Inc., Groton, Connecticut (C.B., X.W., V.S.P.); Biostatistics, Pfizer, Inc., Collegeville, Pennsylvania (A.P.) jonathan.bauman@pfizer.com., Doran AC; Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc., Cambridge, Massachusetts (M.E.D.) andGroton, Connecticut (J.N.B., A.C.D., G.M.G., B.H., T.S., M.A.C.); Clinical Pharmacology, Pfizer, Inc., Groton, Connecticut (C.B., X.W., V.S.P.); Biostatistics, Pfizer, Inc., Collegeville, Pennsylvania (A.P.)., Gualtieri GM; Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc., Cambridge, Massachusetts (M.E.D.) andGroton, Connecticut (J.N.B., A.C.D., G.M.G., B.H., T.S., M.A.C.); Clinical Pharmacology, Pfizer, Inc., Groton, Connecticut (C.B., X.W., V.S.P.); Biostatistics, Pfizer, Inc., Collegeville, Pennsylvania (A.P.)., Hee B; Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc., Cambridge, Massachusetts (M.E.D.) andGroton, Connecticut (J.N.B., A.C.D., G.M.G., B.H., T.S., M.A.C.); Clinical Pharmacology, Pfizer, Inc., Groton, Connecticut (C.B., X.W., V.S.P.); Biostatistics, Pfizer, Inc., Collegeville, Pennsylvania (A.P.)., Strelevitz T; Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc., Cambridge, Massachusetts (M.E.D.) andGroton, Connecticut (J.N.B., A.C.D., G.M.G., B.H., T.S., M.A.C.); Clinical Pharmacology, Pfizer, Inc., Groton, Connecticut (C.B., X.W., V.S.P.); Biostatistics, Pfizer, Inc., Collegeville, Pennsylvania (A.P.)., Cerny MA; Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc., Cambridge, Massachusetts (M.E.D.) andGroton, Connecticut (J.N.B., A.C.D., G.M.G., B.H., T.S., M.A.C.); Clinical Pharmacology, Pfizer, Inc., Groton, Connecticut (C.B., X.W., V.S.P.); Biostatistics, Pfizer, Inc., Collegeville, Pennsylvania (A.P.)., Banfield C; Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc., Cambridge, Massachusetts (M.E.D.) andGroton, Connecticut (J.N.B., A.C.D., G.M.G., B.H., T.S., M.A.C.); Clinical Pharmacology, Pfizer, Inc., Groton, Connecticut (C.B., X.W., V.S.P.); Biostatistics, Pfizer, Inc., Collegeville, Pennsylvania (A.P.)., Plotka A; Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc., Cambridge, Massachusetts (M.E.D.) andGroton, Connecticut (J.N.B., A.C.D., G.M.G., B.H., T.S., M.A.C.); Clinical Pharmacology, Pfizer, Inc., Groton, Connecticut (C.B., X.W., V.S.P.); Biostatistics, Pfizer, Inc., Collegeville, Pennsylvania (A.P.)., Wang X; Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc., Cambridge, Massachusetts (M.E.D.) andGroton, Connecticut (J.N.B., A.C.D., G.M.G., B.H., T.S., M.A.C.); Clinical Pharmacology, Pfizer, Inc., Groton, Connecticut (C.B., X.W., V.S.P.); Biostatistics, Pfizer, Inc., Collegeville, Pennsylvania (A.P.)., Purohit VS; Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc., Cambridge, Massachusetts (M.E.D.) andGroton, Connecticut (J.N.B., A.C.D., G.M.G., B.H., T.S., M.A.C.); Clinical Pharmacology, Pfizer, Inc., Groton, Connecticut (C.B., X.W., V.S.P.); Biostatistics, Pfizer, Inc., Collegeville, Pennsylvania (A.P.)., Dowty ME; Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc., Cambridge, Massachusetts (M.E.D.) andGroton, Connecticut (J.N.B., A.C.D., G.M.G., B.H., T.S., M.A.C.); Clinical Pharmacology, Pfizer, Inc., Groton, Connecticut (C.B., X.W., V.S.P.); Biostatistics, Pfizer, Inc., Collegeville, Pennsylvania (A.P.).

Publikováno v: Drug metabolism and disposition: the biological fate of chemicals [Drug Metab Dispos] 2024 Sep 16; Vol. 52 (10), pp. 1124-1136. Date of Electronic Publication: 2024 Sep 16.

Moving Beyond Boundaries: Utilization of Longitudinal Exposure-Response Model for Bounded Outcome Score to Inform Decision Making in the Accelerated Drug Development Paradigm.

Autor: Huh Y; Worldwide Development, Research and Medical, Pfizer Inc, 280 Shennecossett Rd, Groton, CT, 06340, USA. yeamin.huh@pfizer.com., Wojciechowski J; Worldwide Development, Research and Medical, Pfizer Inc, 280 Shennecossett Rd, Groton, CT, 06340, USA., Purohit VS; Worldwide Development, Research and Medical, Pfizer Inc, 280 Shennecossett Rd, Groton, CT, 06340, USA.

Publikováno v: Clinical pharmacokinetics [Clin Pharmacokinet] 2024 Mar; Vol. 63 (3), pp. 381-394. Date of Electronic Publication: 2024 Feb 15.

Evaluation of the effect of ritlecitinib on the pharmacokinetics of caffeine in healthy participants.

Autor: Liu J; Clinical Pharmacology, Pfizer Investment Co., Ltd., 9/F, Tower B, Minmetals Plaza, Dongcheng District, Beijing, 100010, China., Solan R; Pfizer Research & Development UK Limited, Hurley, UK., Wolk R; Pfizer Global Research & Development, Groton, Connecticut, USA., Plotka A; Biostatistics, Pfizer Inc., Collegeville, Pennsylvania, USA., O'Gorman MT; Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA., Winton JA; Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA., Kaplan J; Pfizer Inc., La Jolla, California, USA., Purohit VS; Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA.

Publikováno v: British journal of clinical pharmacology [Br J Clin Pharmacol] 2023 Jul; Vol. 89 (7), pp. 2208-2215. Date of Electronic Publication: 2023 Mar 02.

Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program.

Autor: Galluppi GR; Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts, USA., Brar S; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA., Caro L; Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA., Chen Y; Department of Drug Metabolism and Pharmacokinetics, Genentech Inc., a member of the Roche Group, South San Francisco, California, USA., Frey N; Roche Pharma Research and Exploratory Development, Pharmaceutical Science, Roche Innovation Center, Basel, Switzerland., Grimm HP; Roche Pharma Research and Exploratory Development, Pharmaceutical Science, Roche Innovation Center, Basel, Switzerland., Rudd DJ; Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA., Li CC; Department of Clinical Pharmacology, Genentech, member of the Roche group, South San Francisco, California, USA., Magee M; GlaxoSmithKline, Philadelphia, Pennsylvania, USA., Mukherjee A; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA., Nagao L; Faegre Drinker Biddle & Reath, LLP, Washington, DC, USA., Purohit VS; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA., Roy A; Bristol Myers, Inc., Woodbury, Connecticut, USA., Salem AH; Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.; Ain Shams University, Cairo, Egypt., Sinha V; Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA., Suleiman AA; Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany., Taskar KS; DMPK, IVIVT, GlaxoSmithKline, Ware, UK., Upreti VV; Clinical Pharmacology Modeling and Simulation, Amgen Inc., South San Francisco, California, USA., Weber B; Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA., Cook J; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Nov; Vol. 110 (5), pp. 1172-1175. Date of Electronic Publication: 2021 May 15.

Randomized phase 2 trial and open-label extension of domagrozumab in Duchenne muscular dystrophy.

Autor: Wagner KR; Center for Genetic Muscle Disorders, Baltimore, Kennedy Krieger Institute, Departments of Neurology and Neuroscience, Johns Hopkins School of Medicine, Baltimore, MD, USA. Electronic address: wagnerk@kennedykrieger.org., Abdel-Hamid HZ; University of Pittsburgh, Pittsburgh, PA, USA., Mah JK; Cumming School of Medicine, University of Calgary, Alberta Children's Hospital, Calgary, AB, Canada., Campbell C; Department of Pediatrics, Clinical Neurological Sciences and Epidemiology, University of Western Ontario, Children's Hospital London Health Sciences Centre, London, ON, Canada., Guglieri M; The John Walton Muscular Dystrophy Research Centre, Newcastle University and Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK., Muntoni F; NIHR Great Ormond Street Hospital Biomedical Research Centre, Great Ormond Street Institute of Child Health, University College London, & Great Ormond Street Hospital Trust, London, UK., Takeshima Y; Hyogo College of Medicine, Nishinomiya, Hyogo, Japan., McDonald CM; Lawson Health Research Institute: Children's Hospital, London, ON, Canada., Kostera-Pruszczyk A; Department of Neurology, Medical University of Warsaw, Warsaw, Poland., Karachunski P; University of Minnesota, Minneapolis, MN, USA., Butterfield RJ; University of Utah School of Medicine, Salt Lake City, UT, USA., Mercuri E; Paediatric Neurology, Catholic University, Rome, Italy; Centro Clinico Nemo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy., Fiorillo C; IRCCS Giannina Gaslini, Genova, Italy., Bertini ES; Bambino Gesu Children's Research Hospital IRCCS, Rome, Italy., Tian C; Cincinnati Children's Hospital Medical Center; College of Medicine University of Cincinnati, Cincinnati, OH, USA., Statland J; University of Kansas Medical Center, Kansas City, KS, USA., Sadosky AB; Pfizer Inc, New York, NY, USA., Purohit VS; Pfizer Inc, Cambridge, MA, USA., Sherlock SP; Pfizer Inc, Cambridge, MA, USA., Palmer JP; Pfizer Inc, Cambridge, MA, USA., Binks M; Pfizer Inc, Cambridge, MA, USA., Charnas L; Pfizer Inc, Cambridge, MA, USA., Marraffino S; Pfizer Inc, Cambridge, MA, USA., Wong BL; University of Massachusetts Medical School, Worcester, MA, USA.

Publikováno v: Neuromuscular disorders : NMD [Neuromuscul Disord] 2020 Jun; Vol. 30 (6), pp. 492-502. Date of Electronic Publication: 2020 May 19.