Ethnic differences in pharmacokinetics in new drug applications and approved doses in Japan.

摘要

Ethnic difference has been gaining attention in recent drug development. Typically, global companies start clinical development in Japan after the United States and Europe, and clinical data packages filed in Japan often include foreign clinical data. To correctly interpret and apply the results of clinical trials in different populations, the differences in phar-macokinetic (PK) parameters play an important role. The International Conference on Harmonization (ICH) E5 guideline (E5 GL), which states the basic concepts in extrapolating clinical data of one region to another, requires consideration of pharmacokinetic differences between the regions as one of the ethnic influences.