Bridging studies in clinical trials for new drug application
- VernacularTitle:新药临床试验中的桥接试验
- Author:
Weiquan XIN
;
Pengcheng XUN
;
Hao YU
;
Feng CHEN
- Publication Type:Journal Article
- Keywords:
bridging study;
bridging strategy;
bridging justification;
ethnic factor;
extrapolation;
similarity
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2000;0(03):-
- CountryChina
- Language:Chinese
-
Abstract:
AIM:To introduce the concept of bridging study and its strategies in clinical trials for new drug application.METHODS:The concept of bridging study proposed in the ICH E5 guideline was introduced,with a case using bridging strategies in the new drug applications(NDAs)approved by the regulatory authority in Japan.The concrete mode and the development of bridging studies in Asia were summarized.RESULTS:With the application of the ICH E5,some countries and regions have successfully used the bridging strategy in the new drug applications.The bridging strategy is becoming a common and practical basis for the decision making of marketing approvals of new drugs in the Asia-pacific country.CONCLUSION:The currently bridging studies in Asia will play an important role in the extrapolation of foreign clinical data in new drug application.Using bridging study is very helpful in judging ethnic differences of drugs,reducing duplication of clinical trails,as well as shortening clinical development periods.
