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. |
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| 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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| FullText | Links: – Type: pdflink Text: Availability: 1 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 38519861 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Galluppi+GR%22">Galluppi GR</searchLink>; Sumitomo Pharma America, Marlborough, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Ahamadi+M%22">Ahamadi M</searchLink>; Sanofi US, Bridgewater, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Bhattacharya+S%22">Bhattacharya S</searchLink>; Astellas Pharma US Inc., Cambridge, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Budha+N%22">Budha N</searchLink>; BeiGene USA Inc., San Mateo, California, USA.<br /><searchLink fieldCode="AU" term="%22Gheyas+F%22">Gheyas F</searchLink>; Merck & Co., Inc, Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Li+CC%22">Li CC</searchLink>; Genentech Inc, South San Francisco, California, USA.<br /><searchLink fieldCode="AU" term="%22Chen+Y%22">Chen Y</searchLink>; Genentech Inc, South San Francisco, California, USA.<br /><searchLink fieldCode="AU" term="%22Dosne+AG%22">Dosne AG</searchLink>; The Janssen Pharmaceutical Companies of Johnson & Johnson, Beerse, Belgium.<br /><searchLink fieldCode="AU" term="%22Kristensen+NR%22">Kristensen NR</searchLink>; Novo Nordisk A/S, Bagsvaerd, Denmark.<br /><searchLink fieldCode="AU" term="%22Magee+M%22">Magee M</searchLink>; GSK, Phoenixville, Pennsylvania, USA.<br /><searchLink fieldCode="AU" term="%22Samtani+MN%22">Samtani MN</searchLink>; Johnson & Johnson Innovative Medicine, Raritan, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Sinha+V%22">Sinha V</searchLink>; Novartis Institute of Biomedical Research, Berwyn, Pennsylvania, USA.<br /><searchLink fieldCode="AU" term="%22Taskar+K%22">Taskar K</searchLink>; GSK, Stevenage, UK.<br /><searchLink fieldCode="AU" term="%22Upreti+VV%22">Upreti VV</searchLink>; Amgen Inc., South San Fracisco, California, USA.<br /><searchLink fieldCode="AU" term="%22Yang+J%22">Yang J</searchLink>; Astellas Pharma Inc., Northbrook, Illinois, USA.<br /><searchLink fieldCode="AU" term="%22Cook+J%22">Cook J</searchLink>; A2-Ai LLC, Ann Arbor, Michigan, USA. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%220372741%22">Clinical pharmacology and therapeutics</searchLink> [Clin Pharmacol Ther] 2024 Aug; Vol. 116 (2), pp. 282-288. <i>Date of Electronic Publication: </i>2024 Mar 22. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Review; Research Support, Non-U.S. Gov't – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Wiley%22">Wiley </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>0372741 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1532-6535 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2200099236%22">00099236 </searchLink><i>NLM ISO Abbreviation: </i>Clin Pharmacol Ther <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=38519861 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1002/cpt.3245 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 282 Titles: – TitleFull: Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Galluppi GR – PersonEntity: Name: NameFull: Ahamadi M – PersonEntity: Name: NameFull: Bhattacharya S – PersonEntity: Name: NameFull: Budha N – PersonEntity: Name: NameFull: Gheyas F – PersonEntity: Name: NameFull: Li CC – PersonEntity: Name: NameFull: Chen Y – PersonEntity: Name: NameFull: Dosne AG – PersonEntity: Name: NameFull: Kristensen NR – PersonEntity: Name: NameFull: Magee M – PersonEntity: Name: NameFull: Samtani MN – PersonEntity: Name: NameFull: Sinha V – PersonEntity: Name: NameFull: Taskar K – PersonEntity: Name: NameFull: Upreti VV – PersonEntity: Name: NameFull: Yang J – PersonEntity: Name: NameFull: Cook J IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 08 Text: 2024 Aug Type: published Y: 2024 Identifiers: – Type: issn-electronic Value: 1532-6535 Numbering: – Type: volume Value: 116 – Type: issue Value: 2 Titles: – TitleFull: Clinical pharmacology and therapeutics Type: main |
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