Kirchheiner Julia, Fuhr Uwe, Brockmöller Jürgen
Department of Pharmacology, University of Cologne, Gleueler Strasse 24, 50931, Köln, Germany.
Nat Rev Drug Discov. 2005 Aug;4(8):639-47. doi: 10.1038/nrd1801.
Although considerable progress has been made in basic pharmacogenetic research, less has been demonstrated in the application of pharmacogenetics (PGx)-based diagnostics to drug development and in clinical practice. There are drugs that are currently used in the clinic for which individualized therapy could be beneficial based on PGx data. However, specific, actionable recommendations on how to implement individualized therapy--particularly with respect to dosage--still have to be developed. Moreover, to apply PGx efficiently in clinical drug development, and later in drug therapy, study designs and the generation and handling of PGx data need to become more standardized. Here, we argue for the development of concise guidelines for implementation of PGx analyses in drug development and therapy.
尽管基础药物遗传学研究已取得显著进展,但在基于药物遗传学(PGx)的诊断方法应用于药物研发及临床实践方面,所取得的成果较少。目前临床上使用的一些药物,基于PGx数据进行个体化治疗可能有益。然而,关于如何实施个体化治疗,尤其是在剂量方面的具体、可行的建议仍有待制定。此外,为了在临床药物研发及后续药物治疗中有效应用PGx,研究设计以及PGx数据的生成和处理需要更加标准化。在此,我们主张制定在药物研发和治疗中实施PGx分析的简明指南。