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The analysis of unconventional research projects and common problems in the in vitro consistency evaluation of oral solid generic drugs / 药学学报
Acta Pharmaceutica Sinica ; (12): 1739-1744, 2021.
Artigo em Chinês | WPRIM | ID: wpr-881561
ABSTRACT
Based on the "requirements on the submitted documents for consistency evaluation of generic oral solid dosage forms of chemical drugs" and relevant guidance, this article summarized and formulated the decision tree of in vitro consistency evaluation of oral solid generic drugs, discussed the differences and common problems of in vitro evaluation research projects under different conditions, selective analyzed the technical requirements and concern problems of unconventional research projects, and proposed corresponding recommendations for concern problems, in order to provide more references for the follow-up study on consistency evaluation of oral solid generic drugs.

Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Tipo de estudo: Estudo observacional / Estudo prognóstico Idioma: Chinês Revista: Acta Pharmaceutica Sinica Ano de publicação: 2021 Tipo de documento: Artigo

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Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Tipo de estudo: Estudo observacional / Estudo prognóstico Idioma: Chinês Revista: Acta Pharmaceutica Sinica Ano de publicação: 2021 Tipo de documento: Artigo