The history of regulated bioanalysis and circumstances in Japan

This is a topical report for the Bioanalytical Method Validation (BMV) on a quantification of drugs in biological matrices such as plasma, urine, or tissue. Bioanalysis is performed in pharmacokinetic, toxicokinetics and bioequivalence studies and the results are used for the critical pharmacokinetic information. The purpose of this report is to represent the world history of the bioanalysis for the small molecules and, as recent topics, the global harmonization on regulated bioanalysis by Global Bioanalysis Consortium and the draft guideline on BMV in Japan prepared by Japan Bioanalysis Forum.