Physiologically Based Pharmacokinetic Modeling: From Regulatory Science to Regulatory Policy

Assessment of controllable sources of intra‐ and interpatient variability in drug response is of critical importance in the regulatory evaluation of new drugs. 1 Although determinants of response variability would ideally be understood and accounted for before approval of a new pharmaceutical product, this is rarely the case for all; clinical trials in specific populations that definitively test optimal dosing in patient management strategies are not routinely performed prior to drug approval. Clinical Pharmacology & Therapeutics (2014); 95 5, 478–480. doi: 10.1038/clpt.2014.46