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Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.
Mehta, Mehul U; Uppoor, Ramana S; Conner, Dale P; Seo, Paul; Vaidyanathan, Jayabharathi; Volpe, Donna A; Stier, Ethan; Chilukuri, Dakshina; Dorantes, Angelica; Ghosh, Tapash; Mandula, Haritha; Raines, Kimberly; Dhanormchitphong, Pariban; Woodcock, Janet; Yu, Lawrence X.
Afiliação
  • Mehta MU; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Uppoor RS; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Conner DP; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Seo P; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Vaidyanathan J; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Volpe DA; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Stier E; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Chilukuri D; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Dorantes A; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Ghosh T; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Mandula H; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Raines K; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Dhanormchitphong P; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Woodcock J; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
  • Yu LX; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Mol Pharm ; 14(12): 4334-4338, 2017 12 04.
Article em En | MEDLINE | ID: mdl-29076742
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Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Biofarmácia / Medicamentos Genéricos / Aprovação de Drogas / Indústria Farmacêutica Tipo de estudo: Guideline / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Mol Pharm Assunto da revista: BIOLOGIA MOLECULAR / FARMACIA / FARMACOLOGIA Ano de publicação: 2017 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 Bases de dados: MEDLINE Assunto principal: Biofarmácia / Medicamentos Genéricos / Aprovação de Drogas / Indústria Farmacêutica Tipo de estudo: Guideline / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Mol Pharm Assunto da revista: BIOLOGIA MOLECULAR / FARMACIA / FARMACOLOGIA Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Estados Unidos