Introduction and analysis of guidance for industry bioequivalence recommendations for specific products issued by FDA / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 1615-1621, 2016.
Artículo
en Chino
| WPRIM
| ID: wpr-858978
ABSTRACT
OBJECTIVE:
To investigate Guidance for Industry Bioequivalence Recommendations for specific products issued by FDA.METHOD:
Combination with FDA and CFDA issued guidance related to Bioequivalence (up to May 20th, 2016), 185 FDA issued Guidance for Bioequivalence Recommendations for Specific Products were discussed, which are involved in the CFDA announced initial list of the equivalence assessment of quality and curative effect for generic products.RESULTS:
Bioequivalence Recommendations for Specific Products issued by FDA is to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment, as an extension and implement to the guideline involved in the aspect of bioequivalence.CONCLUSION:
Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since CFDA haven't released similar guidance on specific products yet.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Tipo de estudio:
Guía de Práctica Clínica
Idioma:
Chino
Revista:
Chinese Pharmaceutical Journal
Año:
2016
Tipo del documento:
Artículo
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