가교자료생성 임상시험 한국인만을 대상으로 한 추가 3상 임상시험이 필요한가? (Clinical Trials for Generation of Bridging Data Do we need “Koreans only” additional phase III trials for generation of bridging data?)

서지정보

· 발행기관 : 대한임상약리학회
· 수록지 정보 : Translational and Clinical Pharmacology / 17권 / 2호 / 119 ~ 123페이지
· 저자명 : 최성준

초록

The registration of new drug is more difficult every year because health authority requests more data on efficacy and safety, especially in long-term clinical trials. In Korea, health authority usually requests bridging data in Korean subjects in order to evaluate the possibility of extrapolation of foreign data to Korean population. But multinational developmental clinical trials from phase 1 to 3 in Korea are ongoing increasingly and it is the time to evaluate the clinical data in the viewpoint of global drug development. Sometimes phase 3 trial for Koreans only may be the waste of resources and the barrier to delay the access for Korean patients even though the drug is available in other countries some years earlier. In scientific point of view, other methods such as Pharmacokinetics / Pharmacodynamics simulation and modeling may be the one of the options to evaluate the ethnic sensitivity.
In this article, I explain the issues in the generation of brdiging data using additional Koreans only phase 3 trial and the possible alternative for the future.

영어초록

The registration of new drug is more difficult every year because health authority requests more data on efficacy and safety, especially in long-term clinical trials. In Korea, health authority usually requests bridging data in Korean subjects in order to evaluate the possibility of extrapolation of foreign data to Korean population. But multinational developmental clinical trials from phase 1 to 3 in Korea are ongoing increasingly and it is the time to evaluate the clinical data in the viewpoint of global drug development. Sometimes phase 3 trial for Koreans only may be the waste of resources and the barrier to delay the access for Korean patients even though the drug is available in other countries some years earlier. In scientific point of view, other methods such as Pharmacokinetics / Pharmacodynamics simulation and modeling may be the one of the options to evaluate the ethnic sensitivity.
In this article, I explain the issues in the generation of brdiging data using additional Koreans only phase 3 trial and the possible alternative for the future.

참고자료

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