Premium
Physiologically Based Pharmacokinetic Modeling: From Regulatory Science to Regulatory Policy
Author(s) -
Sinha V,
Zhao P,
Huang S M,
Zineh I
Publication year - 2014
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2014.46
Subject(s) - clinical pharmacology , regulatory science , pharmacology , dosing , drug , pharmacokinetics , clinical trial , medicine , drug development , drug approval , intensive care medicine , pathology
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