Your browser doesn't support javascript.
loading
Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions.
Wittayanukorn, Saranrat; Rosenberg, Matthew; Schick, Andreas; Hu, Meng; Wang, Zhong; Babiskin, Andrew; Lionberger, Robert; Zhao, Liang.
Afiliación
  • Wittayanukorn S; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Rosenberg M; Office of Program and Strategic Analysis, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Schick A; Office of Program and Strategic Analysis, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Hu M; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Wang Z; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Babiskin A; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA. Andrew.Babiskin@fda.hhs.gov.
  • Lionberger R; Office of Research and Standards, Office of Generic Drugs, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
  • Zhao L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA.
Ther Innov Regul Sci ; 54(6): 1372-1381, 2020 11.
Article en En | MEDLINE | ID: mdl-32495310
Asunto(s)
Palabras clave
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Aprobación de Drogas Tipo de estudio: Guideline / Prognostic_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Ther Innov Regul Sci Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Aprobación de Drogas Tipo de estudio: Guideline / Prognostic_studies Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Ther Innov Regul Sci Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos