3rd Short Course of JSSX

Sekio Nagayama
Chairperson of the Short Course Executive Committee
Pharmacokinetics Research Laboratory
Taiho Pharmaceutical Co., Ltd.

The 3rd Short Course will be held on Thursday, April 23, 2009, prior to the 23rd Workshop of the Japanese Society for the Study of Xenobiotics. The title of the course is "Application of Transporter (Transmembrane) Study in New Drug Development." Based on the recent knowledge of membrane permeation and transporters, how to make transporter studies in drug development is introduced using some cases provided by pharmaceutical companies. This course was designed to be of practical use for pharmacokinetics specialists who belong to a company and are planning to perform membrane permeation experiments or transporter studies.

As for pharmacokinetic research into drug development, a consensus is now obtained for metabolism screening and profiling with a series of studies, including CYP enzyme involvement, identifications of metabolic enzymes and molecular species, enzyme inhibition, and enzyme induction. Also, materials such as expressed enzymes, antibodies, human hepatocytes, and human hepatic microsomes that need to be used in experiments are currently being fully equipped, and recent review reports have been less likely to suggest that investigation into pharmacokinetic research is insufficient.

On the other hand, in terms of applying the transporter study achievements to drug development, there are a variety of ways of applying the transporter study involved in absorption, distribution, and excretion process of a drug in the drug development stage, and also there are a variety of ways of investigating this study. The same also applies to compound development and to various companies.

As shown in the recent FDA guidance (Drug Interaction Studies Study Design, Data Analysis, and Implications for Dosing and Labeling), the transporter study may be incorporated in drug development as a routine procedure as well as studies of metabolic enzymes in the future.

The short course was designed to help attendees gain a basic knowledge of transporter study, establish a position of the transporter study in the drug development, and understand the actual transporter techniques with the use of specific examples, and so I look forward to your participation.