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An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US.
Fisher, Adam C; Liu, William; Schick, Andreas; Ramanadham, Mahesh; Chatterjee, Sharmista; Brykman, Raphael; Lee, Sau L; Kozlowski, Steven; Boam, Ashley B; Tsinontides, Stelios C; Kopcha, Michael.
Afiliação
  • Fisher AC; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
  • Liu W; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
  • Schick A; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
  • Ramanadham M; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
  • Chatterjee S; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
  • Brykman R; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
  • Lee SL; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
  • Kozlowski S; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
  • Boam AB; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
  • Tsinontides SC; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
  • Kopcha M; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
Int J Pharm ; 622: 121778, 2022 Jun 25.
Article em En | MEDLINE | ID: mdl-35500688
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tecnologia Farmacêutica Idioma: En Ano de publicação: 2022 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tecnologia Farmacêutica Idioma: En Ano de publicação: 2022 Tipo de documento: Article