Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006.

摘要: Exploratory analyses of data pertaining to pharmacokinetic, pharmacodynamic, and disease progression are often referred as the pharmacometrics (PM) analyses. The objective current report is assess role PM, at Food Drug Administration (FDA), in drug approval labeling decisions. We surveyed impact PM on New Applications (NDAs) reviewed over 15 months 2005-2006. survey focused both decisions through four perspectives: clinical pharmacology primary reviewer, their team leader, member, reviewer. A total 31 NDAs included a review component. Review involved independent quantitative evaluation by FDA pharmacometricians. were ranked important regulatory decision making 85% NDAs. Case studies presented demonstrate applications analysis.