Pharmacogenomics: Genetic Polymorphism of Receptors and Variation in Drug Response.

Abstract

Human Genome Project (information and technology) provides insights so profound that it has the ability to change everything we know about medicine and how medicines are developed. Genetic factors contribute substantially to variable drug effects and constitute a critical element of a product's profile that must be considered in clinical use. Pharmacogenomics is a rapidly emerging field focused on understanding the genetic factors underlying drug action and applying this information to improve the clinical use and development of pharmaceutical products. In clinical practice, the understanding of how genetic variation leads to variable drug effects can be used to prescribe drugs selectively to individuals in regimens and doses that are most likely to be safe and effective (Personalized Medicine or “Tailor-made Medicine”). Also, pharmacogenomics will promote to develop novel pharmaceutical products targeted to the normal genetic variance of human populations. In drug development, knowledge of genetic variation that may affect drug action can be used to reduce the cost and complexity of clinical trials, increase the success rate of achieving regulatory approval, and achieve approvals for new classes of diagnostic and therapeutic products. Pharmacogenomics programs, thus, enhances the development, commercialization, and clinical use of conventional pharmaceutical products for common diseases, and eventually a powerful tool for Evidence-Based Medicine. Advanced genetic variance discovery technologies to optimize drug treatments and to develop safer and more effective pharmaceutical products, and clinical trial system to test for these variances are clearly required even in Japan, who unfortunately is still far behind in establishing this important discipline.