4 described in this document are also subject to other relevant notifications and guidelines. The active substances mentioned here include a low-molecular-weight chemical entity, a
2 Section 1: Introduction This guideline describes the principles of procedures of bioequivalence studies for oral solid dosage forms that contains a different quantity of the active ingredient from an
- 1 - Clinical Pharmacokinetic Studies of Pharmaceuticals This document is an informal translation of the official text that was promulgated in Japanese on