2015 年 46 巻 6 号 p. 265-272
A questionnaire on conventional “human mass balance (MB) study” was sent to 61 pharmaceutical companies affiliated with the Japan Pharmaceutical Manufacturers Association in 2013, and 48 companies responded. The strategy and design of MB study were also investigated with respect to the approved new molecular entities in Japan and the US from 2002 to 2013. Most companies conduct MB study during proof-of-concept clinical trials or before phase III studies. Additionally, FDA and ICH guidance have encouraged the companies to perform MB studies routinely and/or in an earlier phase. The present survey suggests that MB study has occupied an important position in new drug development, and that implementation of the study appears to be judged carefully taking the necessity into consideration.
