Abstract
Clinical pharmacokinetic studies are conducted to evaluate the absorption, distribution, metabolism and excretion of drugs in healthy volunteers and/or patients. Data obtained from such studies are not only useful for designing and conducting subsequent clinical trials, but also, provide a scientific basis for optimizing drug therapy. Therefore, approved drugs cannot be used appropriately without the types of information obtained from clinical pharmacokinetic studies.
The Japanese Guidance on Clinical Pharmacokinetic Studies indicates the scope and basic principles to be used in designing those clinical pharmacokinetic studies required as part of the Japanese New Drug Applications (NDA) and to satisfy the requirements of Japan's post-marketing surveillance practice. The guidance also recognizes that, because each drug has its own unique set of physicochemical and pharmacokinetic properties, pharmacologic actions, toxicities, and clinical uses, exceptions to the general principles outlined in the document may occur. In the end, the goal is to design the most appropriate development process for a given investigational drug.
This article gives a brief overview of the Japanese Guidance on Clinical Pharmacokinetic Studies (the final draft), from the viewpoint of the Japanese NDA review. A brief introduction to how the ADME part of the NDA is reviewed in the Pharmaceuticals and Medical Devices Evaluation Center is also included.
