Principles of biowaiver about consistency evaluation of generic drug products and varieties of biowaiver in countries and international organizations
10.7501/j.issn.1674-6376.2017.02.003
- VernacularTitle:仿制药质量与疗效一致性评价的生物豁免原则及各国及国际组织的生物等效性豁免品种
- Author:
Dan YANG
;
Chao MA
;
Xinyi CHEN
;
Boying CHEN
;
Xiaowen REN
- Keywords:
bioequivalence;
biowaiver;
BCS classification;
guideline
- From:
Drug Evaluation Research
2017;40(2):157-163
- CountryChina
- Language:Chinese
-
Abstract:
Objective For bioequivalence test of the consistency evaluation of generic drug products,providing a reference of varieties of biowaiver.Methods Based on Human bioequivalence test waiver guidelines (draft),on condition that first drug of the consistency evaluation,to introduce and conclude briefly the standards of biowaiver and varieties of biowaiver in FDA,WHO and EMA.Results Contrast to FDA,there are 59 varieties applied for the waiver and 19 varieties not applied for the waiver in the 289 varietie;compared to WHO,10 drugs are exempted and 1 grug is exempted in EMA.Conclusion At present,the specific list of drugs are not published of biowaiver in our country,the pharmaceutical companies should compare and consult revelant standards and specific drugs in China and abroad,to speed up the progress of the consistency evaluation.
