Clinical pharmacology

Food and drug administration

Engineering

Pharmacokinetics

Medical physics

Regulatory science

Economics

Biochemistry

Computer science

Management science

CLARITY

Management

Political science

Regulatory agency

Sociology

Physiologically based pharmacokinetic modelling

Pharmacology

Artificial intelligence

Public administration

Medicine

Chemistry

Flexibility (engineering)

Perspective (graphical)

Agency (philosophy)

Pathology

Social science

Clinical Pharmacology & Therapeutics

This work provides a perspective on the qualification and verification of physiologically based pharmacokinetic (PBPK) platforms/models intended for regulatory submission based on the collective experience of the Simcyp Consortium members. Examples of regulatory submission of PBPK analyses across various intended applications are presented and discussed. European Medicines Agency (EMA) and US Food and Drug Administration (FDA) recent draft guidelines regarding PBPK analyses and reporting are encouraging, and to advance the use and acceptability of PBPK analyses, more clarity and flexibility are warranted.

Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective