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Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making.
Madabushi, Rajanikanth; Seo, Paul; Zhao, Liang; Tegenge, Million; Zhu, Hao.
Afiliação
  • Madabushi R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. Rajanikanth.Madabushi@fda.hhs.gov.
  • Seo P; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhao L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Tegenge M; Division of Clinical Evaluation and Pharmacology/Toxicology, Office of Tissue and Advanced Therapies, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Zhu H; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. Hao.Zhu@fda.hhs.gov.
Pharm Res ; 39(8): 1669-1680, 2022 Aug.
Article em En | MEDLINE | ID: mdl-35552984
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Genéricos / Desenvolvimento de Medicamentos Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Animals / Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article
Texto completo
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PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Genéricos / Desenvolvimento de Medicamentos Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Animals / Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article