マイクロドーズ臨床試験の実施タイミングとコスト試算

摘要

We compare the time- and cost-saving benefits of microdosing clinical study over those of the traditional phase 1 clinical trial in selecting a drug candidate compound based on a likely scenario of choosing one from two lead compounds deemed promising by the animal data. It was shown that the microdosing clinical study could produce results more than one year faster than the traditional Phase 1 clinical study and at a cost approximately 350 million yen cheaper than that needed for the phase 1 clinical study. The estimated amount of synthesis was a laboratory scale of about 500 grams in the microdosing clinical study, in contrast with a plant scale of about 20 kilograms in the traditional phase 1 study, indicating that microdosing also saves human resource for chemical synthesis. It is clear that the microdosing clinical study could select a candidate compound with a high probability of success. In addition, it has a number of other advantages over the conventional selection by animal data and phase 1 clinical study.