１．マイクロドーズ臨床試験の歴史

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  • 1. The History of Microdose Clinical Trials

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Microdose clinical trials are defined as trials conducted in humans to determine the most appropriate compound(s) among candidate compounds with doses ≤100th the calculated human clinical dose and/or ≤100 μg. In the past 6 years, microdose clinical trials have been adopted by authorities of EU, USA and Japan as a new type of clinical trial conducted at the exploratory stage of drug development to facilitate new drug development. All of the guidelines for microdose clinical trials released by the authorities recommend “extended single dose toxicity studies” to support the conduct of microdose clinical trials, however, the reasons for this are not stated in these guidelines. This is because the concept of “extended single dose toxicity studies” was first introduced by FDA in 1996 to support the conduct of “screening clinical trials”, and the rationale for this type of toxicity study are well established. In that context, a microdose clinical trial is considered to be one of the various types of “screening clinical trials”. In the present paper, the history of microdose clinical trials is retraced including “screening clinical trials”, which was approved initially by FDA in 1996, screening-IND studies approved by FDA in 2001, microdose clinical trials approved by EU/EMEA in 1993, by USA/FDA in 2006 and by Japan/MHRW in 2008, exploratory-IND studies approved by FDA in 2006 and exploratory clinical trials adopted in the ICH-M3 (R2) guideline in 2009.

収録刊行物

  • 臨床薬理

    臨床薬理 41 (1), 2-8, 2009

    一般社団法人 日本臨床薬理学会

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