Regulatory Guidances

• European Medical Agency Modeling and Simulation Working Party

  • Guideline on Pop PK reports

• Food and Drug Administration (FDA) Division of Pharmacometrics

  • Population pharmacokinetics - Guidance for industry

• The Pharmaceuticals and Medical Devices Agency is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan

  • Meeting Report: PMDA Public Workshop on Pharmacometrics at Japan
  • PMDA Guideline on Population Pharmacokinetic and Pharmacodynamic Analysis
  • PMDA Guideline for Exposure-Response Analysis of Drugs