Bridging studies in clinical trials for new drug application

Abstract

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.

Key words: bridging study, bridging strategy, bridging justification, ethnic factor, extrapolation, similarity

CLC Number:

R969

XIN Wei-quan, XUN Peng-cheng, YU Hao, CHEN Feng. Bridging studies in clinical trials for new drug application[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2008, 13(3): 309-314.

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