Modeling and simulation are a proven scientific approach used to inform crucial drug development decisions. Specifically, scientists from the FDA Office of Clinical Pharmacology have affirmed the utility of physiologically-based pharmacokinetic (PBPK) for optimizing trial designs, predicting the impact of intrinsic and extrinsic factors on PK, and developing dosing recommendations for special populations. Indeed, approximately 50 of new approval drugs by the FDA in 2019 incorporated this approach in their approval filings (The Journal of Clinical Pharmacology 2020, 60(S1) S160–S178).
In October 2020, the FDA Center for Drug Evaluation and Research (CDER) updated the draft guidance “The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls”.
PBPK modeling uses virtual populations to predict the absorption, distribution, metabolism and excretion (ADME) of a drug. PBPK enables drug developers to predict drug exposure levels based on patient and drug characteristics, and concomitant medications.
The benefit of using PBPK modeling is that it is a cost-effective and robust predictive tool that is devoid of the ethical challenges associated with clinical trials in sensitive populations (e.g. cancer patients, pediatrics, pregnant women, etc.).
“RPN has successfully supported clients to provide innovative strategic solutions including modelling and simulation tools to optimize drug development decisions largely accepted by regulators and used across the development cycle”.