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Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report.
Heimbach, Tycho; Suarez-Sharp, Sandra; Kakhi, Maziar; Holmstock, Nico; Olivares-Morales, Andrés; Pepin, Xavier; Sjögren, Erik; Tsakalozou, Eleftheria; Seo, Paul; Li, Min; Zhang, Xinyuan; Lin, Ho-Pi; Montague, Timothy; Mitra, Amitava; Morris, Denise; Patel, Nikunjkumar; Kesisoglou, Filippos.
Afiliação
  • Heimbach T; Department of PK Sciences, PBPK and Biopharmaceutics Section, Novartis Institutes for BioMedical Research, East Hanover, New Jersey, USA.
  • Suarez-Sharp S; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Kakhi M; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Holmstock N; Pharmaceutical Sciences, Small Molecule Pharmaceutical Development, Janssen Research and Development, Beerse, Belgium.
  • Olivares-Morales A; Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Basel, Switzerland.
  • Pepin X; AstraZeneca, Global Medicines Development, Pharmaceutical Development, Hurdsfield Industrial Estate, Silk Road Business Park, Charter Way, Macclesfield, SK10 2NA, UK.
  • Sjögren E; Department of Pharmacy, Uppsala University, Box 580, 751 23, Uppsala, Sweden.
  • Tsakalozou E; Pharmetheus, 752 37, Uppsala, Sweden.
  • Seo P; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Li M; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhang X; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Lin HP; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Montague T; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Mitra A; GSK, 1250 South Collegeville Road, P.O. Box 5089, Collegeville, Pennsylvania, 19426-0989, USA.
  • Morris D; Clinical Development, Sandoz, Inc. (A Novartis Division), Princeton, New Jersey, USA.
  • Patel N; Cognigen Corporation, a Simulations Plus Company, Buffalo, New York, USA.
  • Kesisoglou F; Simcyp Limited (a Certara Company), Sheffield, S2 4SU, UK.
AAPS J ; 21(2): 29, 2019 02 11.
Article em En | MEDLINE | ID: mdl-30746576
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Biofarmácia / Desenvolvimento de Medicamentos / Modelos Biológicos Tipo de estudo: Guideline / Prognostic_studies Idioma: En Revista: AAPS J Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Biofarmácia / Desenvolvimento de Medicamentos / Modelos Biológicos Tipo de estudo: Guideline / Prognostic_studies Idioma: En Revista: AAPS J Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos