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Commentary on Fit-For-Purpose Models for Regulatory Applications.

Yaning Wang1, Shiew Mei Huang1

  • 1Office of Clinical Pharmacology, Office of Translational Sciences, U.S. Food and Drug Administration, Silver Spring, Maryland 20903.

Journal of Pharmaceutical Sciences
|September 24, 2018
PubMed
Summary

Model-based analyses are increasingly influencing drug development and regulatory decisions. The integration of Model-Informed Drug Development into PDUFA VI marks a significant advancement for quantitative clinical pharmacology.

Keywords:
ADMEclinical trial simulation(s)computationalpharmacokinetic/pharmacodynamic (PK/PD) modelingphysiologically based pharmacokinetic (PBPK) modelingregulatory science

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Area of Science:

  • Pharmacometrics and Drug Development
  • Quantitative Clinical Pharmacology

Background:

  • Model-based analyses have guided drug development and regulatory decisions for two decades.
  • Models range from empirical to complex mechanistic types, guided by a "fit-for-purpose" principle.

Purpose of the Study:

  • To review the evolution and impact of model-based analyses in drug development.
  • To highlight the growing importance and integration of quantitative methods in regulatory science.

Main Methods:

  • Review of case studies and accumulated experience in model-based analyses.
  • Analysis of the significance of including Model-Informed Drug Development in regulatory frameworks.

Main Results:

  • Model-based analyses have demonstrated value across diverse drug development stages.
  • The "fit-for-purpose" approach ensures appropriate model complexity for decision-making.

Conclusions:

  • Model-based analyses are integral to modern drug development and regulatory affairs.
  • The inclusion in PDUFA VI signifies a new era for quantitative clinical pharmacology and evidence-based decision-making.