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Assessment of Manufacturing Related Deficiencies for Modified Release Tablet in Abbreviated New Drug Applications.
Chen, Jim; Wang, Zhouxi; Shah, Rakhi; Scherlitz, Anna; Feng, Xin; Chen, Jocelyn; Wu, Larisa.
Afiliação
  • Chen J; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. jim.chen@fda.hhs.gov.
  • Wang Z; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
  • Shah R; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
  • Scherlitz A; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
  • Feng X; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
  • Chen J; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
  • Wu L; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
AAPS PharmSciTech ; 23(7): 268, 2022 Sep 27.
Article em En | MEDLINE | ID: mdl-36168006
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Genéricos / Aprovação de Drogas Tipo de estudo: Prognostic_studies País/Região como assunto: America do norte 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: Medicamentos Genéricos / Aprovação de Drogas Tipo de estudo: Prognostic_studies País/Região como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article