Introduction and analysis of Food and Drug Administration (FDA) issued Guidance on Bioequivalence Recommendations for Specific Products and Japan's Orange Book related with endogenous compound
10.13699/j.cnki.1001-6821.2017.22.024
- VernacularTitle:美国食品药品监督管理局《特定药物的生物等效性指导原则》和日本橙皮书中关于口腔崩解片生物等效性试验介绍
- Author:
Qian LIU
1
;
Nan NAN
;
Ming-Di XU
Author Information
1. 中国食品药品检定研究院仿制药质量研究中心
- Keywords:
endogenous compound;
bioequivalence study;
biowaiver;
analytes to measure;
agreement evaluation of generic drug products
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(22):2303-2307
- CountryChina
- Language:Chinese
-
Abstract:
To study and analyze Food and Drug Administration(FDA) issued guidance on Bioequivalence Recommendations for Specific Products and Japan's Orange Book related with endogenous compounds.Recommendations were analyzed from multiple aspects,including study design,selection of bioequivalence subjects,dosage,analytes to measure,etc.These guidances have important inspiration of the agreement evaluation of generic drug products in China.
