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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.
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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  Data: Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program.
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  Data: <searchLink fieldCode="AU" term="%22Galluppi+GR%22">Galluppi GR</searchLink>; Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Brar+S%22">Brar S</searchLink>; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.<br /><searchLink fieldCode="AU" term="%22Caro+L%22">Caro L</searchLink>; Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Chen+Y%22">Chen Y</searchLink>; Department of Drug Metabolism and Pharmacokinetics, Genentech Inc., a member of the Roche Group, South San Francisco, California, USA.<br /><searchLink fieldCode="AU" term="%22Frey+N%22">Frey N</searchLink>; Roche Pharma Research and Exploratory Development, Pharmaceutical Science, Roche Innovation Center, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Grimm+HP%22">Grimm HP</searchLink>; Roche Pharma Research and Exploratory Development, Pharmaceutical Science, Roche Innovation Center, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Rudd+DJ%22">Rudd DJ</searchLink>; Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Li+CC%22">Li CC</searchLink>; Department of Clinical Pharmacology, Genentech, member of the Roche group, South San Francisco, California, USA.<br /><searchLink fieldCode="AU" term="%22Magee+M%22">Magee M</searchLink>; GlaxoSmithKline, Philadelphia, Pennsylvania, USA.<br /><searchLink fieldCode="AU" term="%22Mukherjee+A%22">Mukherjee A</searchLink>; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.<br /><searchLink fieldCode="AU" term="%22Nagao+L%22">Nagao L</searchLink>; Faegre Drinker Biddle & Reath, LLP, Washington, DC, USA.<br /><searchLink fieldCode="AU" term="%22Purohit+VS%22">Purohit VS</searchLink>; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.<br /><searchLink fieldCode="AU" term="%22Roy+A%22">Roy A</searchLink>; Bristol Myers, Inc., Woodbury, Connecticut, USA.<br /><searchLink fieldCode="AU" term="%22Salem+AH%22">Salem AH</searchLink>; Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.; Ain Shams University, Cairo, Egypt.<br /><searchLink fieldCode="AU" term="%22Sinha+V%22">Sinha V</searchLink>; Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Suleiman+AA%22">Suleiman AA</searchLink>; Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.<br /><searchLink fieldCode="AU" term="%22Taskar+KS%22">Taskar KS</searchLink>; DMPK, IVIVT, GlaxoSmithKline, Ware, UK.<br /><searchLink fieldCode="AU" term="%22Upreti+VV%22">Upreti VV</searchLink>; Clinical Pharmacology Modeling and Simulation, Amgen Inc., South San Francisco, California, USA.<br /><searchLink fieldCode="AU" term="%22Weber+B%22">Weber B</searchLink>; Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA.<br /><searchLink fieldCode="AU" term="%22Cook+J%22">Cook J</searchLink>; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.
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  Data: <searchLink fieldCode="JN" term="%220372741%22">Clinical pharmacology and therapeutics</searchLink> [Clin Pharmacol Ther] 2021 Nov; Vol. 110 (5), pp. 1172-1175. <i>Date of Electronic Publication: </i>2021 May 15.
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