A guide to developing population files for physiologically-based pharmacokinetic modeling in the Simcyp Simulator.

ABSTRACT: The Simcyp Simulator is a software platform widely used in the pharmaceutical industry to conduct stochastic physiologically-based pharmacokinetic (PBPK) modeling. This approach has the advantage of combining routinely generated in vitro data on drugs and drug products with knowledge of biology and physiology parameters to predict a priori potential pharmacokinetic changes in absorption, distribution, metabolism, and excretion for populations of interest. Combining such information with pharmacodynamic knowledge of drugs enables planning for potential dosage adjustment when clinical studies are feasible. Although the conduct of dedicated clinical studies in some patient groups (e.g., with hepatic or renal diseases) is part of the regulatory path for drug development, clinical studies for a

SUBMITTER: Curry L 

PROVIDER: S-EPMC11533108 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature