Innovative Statistical Strategies for New Drug Development

About this project

The purpose of this project is to understand the features of the innovative statistical strategies, such as modeling & simulation and adaptive design, and to discuss their potential of use in new drug development. The information on the strategies and content of the discussion will be shared across multi-offices in PMDA.

Research topics

This project investigates the following three topics, which have been designated as the regulatory science research of PMDA:

  • Cross-product evaluation of placebo effects in neuropsychiatric disorders
  • Use of pharmacokinetic-pharmacodynamic (PK-PD) modeling and simulation for determining pediatric dosage from the comparison of PK-PD profiles between adults and children.
  • Evaluation of the effects of ethnic factors on the efficacy and safety of the drug based on global clinical trial data