Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program.

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Title: Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program.
Authors: Galluppi GR; Sumitomo Pharma America, Marlborough, Massachusetts, USA., Ahamadi M; Sanofi US, Bridgewater, New Jersey, USA., Bhattacharya S; Astellas Pharma US Inc., Cambridge, Massachusetts, USA., Budha N; BeiGene USA Inc., San Mateo, California, USA., Gheyas F; Merck & Co., Inc, Rahway, New Jersey, USA., Li CC; Genentech Inc, South San Francisco, California, USA., Chen Y; Genentech Inc, South San Francisco, California, USA., Dosne AG; The Janssen Pharmaceutical Companies of Johnson & Johnson, Beerse, Belgium., Kristensen NR; Novo Nordisk A/S, Bagsvaerd, Denmark., Magee M; GSK, Phoenixville, Pennsylvania, USA., Samtani MN; Johnson & Johnson Innovative Medicine, Raritan, New Jersey, USA., Sinha V; Novartis Institute of Biomedical Research, Berwyn, Pennsylvania, USA., Taskar K; GSK, Stevenage, UK., Upreti VV; Amgen Inc., South San Fracisco, California, USA., Yang J; Astellas Pharma Inc., Northbrook, Illinois, USA., Cook J; A2-Ai LLC, Ann Arbor, Michigan, USA.
Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Aug; Vol. 116 (2), pp. 282-288. Date of Electronic Publication: 2024 Mar 22.
Publication Type: Journal Article; Review; Research Support, Non-U.S. Gov't
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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Description
ISSN:1532-6535
DOI:10.1002/cpt.3245