Ontology highlight
ABSTRACT:
SUBMITTER: Suri A
PROVIDER: S-EPMC5039936 | biostudies-literature | 2015 Sep
REPOSITORIES: biostudies-literature
Suri A A Chapel S S Lu C C Venkatakrishnan K K
Clinical pharmacology and therapeutics 20150714 3
Physiologically based pharmacokinetic (PBPK) modeling and classical population pharmacokinetic (PK) model-based simulations are increasingly used to answer various drug development questions. In this study, we propose a methodology to optimize the development of drugs, primarily cleared by the kidney, using model-based approaches to determine the need for a dedicated renal impairment (RI) study. First, the impact of RI on drug exposure is simulated via PBPK modeling and then confirmed using clas ...[more]