Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.

摘要: The value of quantitative thinking in drug development and regulatory review is increasingly being appreciated. Modeling simulation data pertaining to pharmacokinetic, pharmacodynamic, disease progression often referred as the pharmacometrics analyses. objective current report assess role at US Food Drug Administration (FDA) making approval labeling decisions. New Applications (NDAs) submitted between 2000 2004 Cardio-renal, Oncology, Neuropharmacology products divisions were surveyed. For those NDA reviews that included a consultation, clinical pharmacology scientists ranked impact on decision(s). Of about total 244 NDAs, 42 component. Review NDAs involved independent, evaluation by FDA pharmacometricians, even when such analysis was not conducted sponsor. Pharmacometric analyses pivotal decision more than half NDAs. 14 related decisions, 5 identified need for additional trials, whereas 6 reduced burden conducting trials. Collaboration among pharmacology, medical, statistical reviewers effective communication with sponsors critical occur. survey case studies emphasize early interaction plan efficiently appreciating expectations better.