ICH discussion on pharmacokinetics and toxicokinetics and contributors.

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established in 1990. Since then, representatives of the regulatory authorities and pharmaceutical industries from Europe, Japan and the US have held discussions on issues about the technical requirements for safety, efficacy quality, and multidisciplinary areas. These discussions have led to a harmonization of the worldwide regulations that subsequently contributed to improved scientific and ethical principles along with more efficient new drug development programs. This harmonization also contributed to the promotion of the 3Rs principle of animal experimentation.1) Recently, the discussions in the area of safety were reviewed in the book Global Approach in Safety Testing (van der Laan and DeGeorge, 2013).2) However, issues related to pharmacokinetics (PK) and toxicokinetics were not included. Therefore, this brief report attempts to introduce the discussions, processes and the major contributors. It should be noted, however, that since this report is based on my own recollections and personal recordings, there is a chance that some of the participants and points raised could have been overlooked in this summary. The first items that were discussed in this area included safety evaluations of metabolites, multiple dose tissue distribution and toxicokinetics studies, and the timing of the conduct of non-clinical tests in relation to clinical trials. Please refer to the original guidelines or other reviews for the specific details of these previous discussions.