WS-3 Current status of the use of alternative methods for developmental toxicity testing in drug development by pharmaceutical companies

摘要

A revision of the ICH S5 guideline for reproductive and developmental toxicity studies is currently under discussion. In particular, the usefulness of alternative methods for developmental toxicity testing (in vitro and in vivo) is an important issue. Whole embryo culture and methods using embryonic stem cells or zebrafish are recognized as viable alternative methods. However, there is no clear understanding of the current status of their use in Japan. Therefore, we investigated the current status of the use of alternative methods by member companies of the Japan Pharmaceutical Manufacturers Association in an attempt to facilitate discussion relevant to revision of the S5 guideline.The results showed that the three aforementioned methods were mainly used as alternatives, mostly for developmental toxicity screening in the process of new drug development. On the other hand, one company answered that they were not using any alternative methods and commented that "We do not think these methods are useful as alternatives to traditional animal experimentation." Our results also suggested that the reliability of the measurement tools should be improved. Herein, we present the current status of the use of alternative methods for developmental toxicity testing in pharmaceutical companies in Japan based on the questionnaire results.