Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program.
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| Title: | Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program. |
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| Authors: | 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. |
| Source: | Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Nov; Vol. 110 (5), pp. 1172-1175. Date of Electronic Publication: 2021 May 15. |
| Publication Type: | Journal Article; Review |
| Journal Info: | Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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