今日の論文

• Bhattaram, et al. (2005) AAPS J., "Impact of Pharmacometrics on Drug Approval and Labeling Decisions: A Survey of 42 New Drug Applications"
  • いまさらの紹介ではあるが，一応引用．

The modeling and simulation approaches should not be viewed as substitutes to conducting clinical trials in all instances. Also, such quantitative analyses should not be primarily used to "rescue" failed trials for seeking regulatory approval. Where appropriate, the FDA accepted simulation results.