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Abstract:
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Modeling and simulation of data pertaining to pharmacokinetic, pharmacodynamic, and disease progression often is referred to as the pharmacometrics analyses. The objective of the current report is to assess the role of pharmacometrics, at FDA, in making drug approval and labeling decisions. The NDAs submitted between 2000--2004 to the cardio-renal, oncology, and neuropharmacology drug products divisions were surveyed. Of about 244 NDAs, 42 included a pharmacometrics component. Pharmacometric analyses were pivotal in regulatory decisionmaking in more than half of the 42 NDAs. Of the 14 reviews that were pivotal to approval-related decisions, five identified the need for further trials, while six reduced the burden of conducting additional trials. The survey and case studies emphasize the need for early interaction between the FDA and sponsors.
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