About the AAPS PBPK Workshop
The AAPS PBPK Modelling Workshop ↗ is a focused 3-day hands-on training event designed for pharmaceutical scientists, pharmacokineticists, and regulatory scientists who need working knowledge of physiologically based pharmacokinetic modelling. Unlike large symposia, the workshop format limits attendance to ~200 participants, enabling direct interaction with expert instructors and platform vendors.
The 2027 Boston workshop covers PBPK model building, parameter estimation, validation strategies, and regulatory submission best practices across Simcyp ↗, GastroPlus ↗, and PK-Sim ↗ platforms. Sessions are aligned with the FDA PBPK Guidance (2018) ↗ and EMA PBPK Reporting Guideline ↗.
Regulatory PBPK Applications Covered
| Application | Key considerations | Regulatory guidance |
|---|---|---|
| DDI prediction | Inhibition/induction of CYP3A4, CYP2D6, transporters | FDA DDI Guidance, ICH M12 |
| Paediatric dose selection | Enzyme ontogeny, GFR maturation, body composition scaling | EMA PIP, FDA PREA |
| Renal impairment dosing | GFR-dependent clearance reduction, transporter changes | FDA Renal Guidance 2020 |
| Hepatic impairment dosing | Child-Pugh A/B/C; reduced CYP expression, portal shunting | FDA Hepatic Guidance 2003 |
| Food effect prediction | Gastric pH, bile salts, gastric emptying, splanchnic blood flow | FDA Food Effect Guidance |
| Formulation bridging | IR to MR conversion, BCS class, dissolution-linked absorption | FDA BCS Guidance |
Workshop Sessions
PBPK Fundamentals
Model structure, compartmental physiology, parameter sourcing, mass balance equations, and model implementation in Simcyp/GastroPlus/PK-Sim.
DDI Prediction
CYP inhibition (reversible, time-dependent), induction (PXR/CAR), transporter DDI, and PBPK-based DDI study waiver strategies for FDA/EMA.
Paediatric Extrapolation
Enzyme ontogeny, GFR maturation, allometric scaling, neonatal PK, and PREA/PIP regulatory pathway integration.
Special Populations
Renal and hepatic impairment PBPK, pregnancy PK modelling, obese patient PK, and geriatric physiology.
Regulatory Submissions
FDA and EMA PBPK submission format, model verification/validation reports, sensitivity analyses, and case studies from approved NDAs.
Hands-On Platform Sessions
Supervised modelling exercises in Simcyp, GastroPlus, and PK-Sim with expert instructors; Q&A with platform developers.