JSSX Workshop 2005
Effective PK/PD Approach Promoting Drug Development from Discovery to Clinical Development |Biomarkers Effective Application
Principal Organizer , S. Kobayashi, Ph.D. (Kyowa Hakko Kogyo)
The analysis of relationship between
response (intensity) and concentrations (time course) of a drug in a
biological system, that is PK (Pharmacokinetics)/PD (Pharmacodynamics)
studies, is important to (1) evaluate the pharmacokinetics and (2) elucidate
the relation between effect and the safety and to realize effective
and safe treatments, in the drug development and clinical.
Furthermore, in April of 2003, the FDA@in
the United States issued a guidance on the PK/PD studies, gGuidance
for Industry: Exposure-Response Relationships|Study Design, Data Analysis,
and Regulatory Applicationsh, in which the FDA expresses its opinion
as to in what cases the PK(Exposure)/PD(Response) studies are useful
and what designs of clinical studies are recommended.
One important point in carrying out a PK/PD study is a selection of clinical indices. It can naturally be said that the surrogate endpoint and an endpoint, which reflect how symptoms, biological functions or a survival rate are improved by the administration of a drug is the most reliable index. In recent years, however, biomarkers have been actively evaluated and used. Biomarker refers to a variety of physiologic, pathologic measurements that are considered to relate biological processes caused by diseases. Therefore, to what extent biomarkers reflect clinical endpoints is very important to make PK/PD studies successful. That is, if it becomes possible for biomarkers to sufficiently predict clinical endpoints, they may become surrogate endpoints. PK/PD studies that use biomarkers such as PSA are useful for safe and effective selection of a dose in a later clinical study and it is considered that they will become very important in proceeding with drug development as a whole.
This aims at g Recommendation of practical medicine based on scienceh was described by Professor Tetsuya Kamataki of Graduate School of Pharmaceutical Sciences, Hokkaido University in Farumashia, No.12 in 2004.
As described above, it is considered
that to elucidate the relationships of PK and PD (PK/PD)of drugs leads
to smooth drug developments based on theoretical consideration and also
extremely important in view of medical treatments of individual patients
in the clinical sites. In the workshop this time, we have obtained cooperation
of American and European researchers who are actively working on drug
developments by use of PK/PD. Furthermore, we have requested professors,
doctors and researchers who are working at the front line of universities,
clinical fields and pharmaceutical companies to perform their lectures.
We would like to request many of you to participate in this workshop,
and actively discuss various aspects of PK/PD, to make this workshop
significant and useful.