藥物審查模式及其在藥物基因體學下之因應－以我國及美、加為中心

Drug Evaluation Modes and Solutions under Pharmacogenomics-Focus on Taiwan, the U.S., and Canada

陳昭華(Jau-Hwa Chen) ； 葉馨雯(Hsin-Wen Yeh)

《臺灣科技法律與政策論叢》 7卷2期 (2010/12) Pp. 1-40

https://doi.org/10.7050/TJLTP.201012.0001

摘要

藥物基因種學是運用基因定序所獲得之資訊，結合藥物代謝動力學與藥物藥效學研究而形成之新基因種學應用的學科。透過藥物基因種學之研究，可瞭解相同藥物在不同個體問造成的不一樣藥效反應，進一步提供個人更安全、更適合個人體質的藥物及其劑量，而達到「個人化醫藥」的境界，因此藥物基因體學之導人將大幅提升藥品之安全。而藥物安全之管控首先即表現在藥品審查上。在藥物基因體學下，除藥品原有之審查程序外，勢必須進一步就藥物基因體資訊加以審查，以瞭解藥物反應和個體間基因之差異或多變性之關係。然如何審查藥物基因體資訊較為妥當，許多國多尚在初步研擬階段，有鑑於藥物基因體學為藥學發展上之重要方向，為此，擬對藥物審查在藥物基因體學下之因應加以探討之，以供實務之參考。

關鍵字

藥物基因種學 ； 藥品審查 ； 個人化醫藥

並列摘要

Pharmacogenomics is a new field of application genetics research that applies information from gene sorting, combining with researches of pharmacokinetics and pharmacodynamics. Through research of pharmacogenomics, we can find different reactions when the same drugs dosed to varied individuals. Thus we can further provide safer and more suitable drugs and dosage according to personal situation, which is ＂personalize medicine＂. Therefore, importing of pharmacogenomics can greatly raise safety of drugs. As drug evaluation is the first stage of control over drug safety, when pharmacogenomics applies, the evaluation process must further review pharmacogenomics information in order to recognize the relationship of drug reactions and gene variety of individuals. However, evaluation regulations of pharmacogenomics information are still prototype in many countries. As pharmacogenomics is an important field of pharmacy, this article will discuss on solutions of drug evaluation under pharmacogenomics for reference for the practice.

並列關鍵字

Pharmacogenomics ； drug evaluation ； personalized medicine