Investigation of FDA Issued List and Guidance for Bioequivalence Recommendations for Specific Products Related with Narrow Therapeutic Index Drugs / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 2137-2142, 2018.
Article
in Chinese
| WPRIM
| ID: wpr-858127
ABSTRACT
OBJECTIVE:
To investigate FDA issued lists and guidance on Bioequivalence Recommendations for Specific Products related with Narrow Therapeutic Index Drugs.METHODS:
FDA issued lists and Bioequivalence Recommendations for Specific Products related with Narrow Therapeutic Index Drugs was investigated in multiple aspects, including detailed drugs lists, bioequivalence study designs, selection of bioequivalence subjects,analytes to measure,bioequivalence waiver, selection of reference products.RESULTS:
Keeping updated lists and Bioequivalence Recommendations for Specific Products relative with Narrow Therapeutic Index Issued by FDA are 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.CONCLUSION:
Narrow therapeutic index list and 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 have not released similar list and guidance on specific narrow therapeutic index.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Practice guideline
Language:
Chinese
Journal:
Chinese Pharmaceutical Journal
Year:
2018
Type:
Article
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