Drugs fail the regulatory process for a variety of reasons, including issues with pharmacokinetics, safety and efficacy. One of the most exciting questions in drug development today is how far the science of pharmacogenetics, the study of the genetics of drug response, can be used to address the fundamental issues that the pharmaceutical industry is facing. In particular, the question of how far it is possible to use this emerging science to deliver the right treatment, to the right patient, at the right dose, at the right time is both the challenge and opportunity of using pharmacogenetics in drug development. This review will address these questions with several real-life examples.

Challenges and opportunities of pharmacogenetics in drug development.

7 – Farmacogenética en investigación clínica

Pharmacogenomic-Guided Drug Development

药物基因组(phartnacogenomics,PGm)/药物遗传学(pharmacogenetics,PGt)的研究进展对药物临床研究有重要的指导和促进作用.为促进此研究领域的发展,辅助药物开发,美国FDA和欧洲EMEA分别于2005年和2010年颁布或起草了相关指导原则,明确临床药动学研究中涉及药物代谢酶多态性的PGm/PGt的临床研究方法和数据要求.药物代谢酶对大多数药物的体内过程发挥着至关重要的作用,其功能的多态性是药物药动学个体产生差异的重要因素之一.药物代谢酶多态性也是目前PGm/PGt方向中研究较透彻的领域,在临床药动学研究中的作用得到了更多的认可和关注.本文综合分析了FDA和EMEA的相关指导原则,结合目前国内药物临床研究过程中药物代谢酶多态性的研究现状,分析和探讨了药物代谢酶多态性和临床药动学关联性.

Genetic Polymorphism of Drug Metabolizing Enzymes Incurred in Clinical Pharmacokinetic Studies and Its Implication in New Drug Registration

A McCarthy†1, M Kerr1, E Abadie2, S-D Chibout3, G Imbert3, N Cohen4, N Drakoulis5, LE Knudsen6, B Flamion7, L Hashimoto8, W Verhoofstad8 G Kreutz9, D McHale10, T Mitchell11, M Papaluca Amati12, R Roberts13, P Shaw14, CS Stuerzebecher15 & D Townend16 †Author for correspondence 1Genetics Research, GlaxoSmithKline RD E-mail: alun.d.mccarthy @gsk.com 2AFSSAPs, France 3Novartis Pharma AG, Switzerland 4Johnson & Johnson PRD, USA 5University of Athens, Greece 6University of Copenhagen, Denmark 7Ministry of Public Health Medicines Commission, Belgium 8F. Hoffmann-La Roche Ltd, Switzerland 9Federal Institute for Drugs and Medical Devices, Germany 10Pfizer Ltd., UK 11Irish Medicines Board, Ireland 12EMEA, UK 13Aventis Pharma SA, France 14Bristol-Myers Squibb 15Schering AG, Germany 16University of Sheffield, UK

Report on the joint EFPIA, DIA and EMEA pharmacogenetics workshop: moving toward clinical application.

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Report on the joint EFPIA, DIA and EMEA pharmacogenetics workshop: moving toward clinical application.