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PBPK modeling allows predictions of local and systemic API concentrations following the integration of in vitro measurements on critical quality and performance attributes directly into the model structure or by establishing in vitro-in vivo correlations (IVIVCs) for drug products for which in vitro data on formulation characterization and pharmacokinetic data are available.

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PBPK modeling is a bottom-up approach that integrates a large number of drug specific data, parameters on species physiology (system data), and a good understanding of all active processes affecting the pharmacokinetic properties of a drug. Physiologically-based pharmacokinetic (PBPK) modeling is becoming increasingly important in human health risk assessments and in supporting pharmacodynamic modeling for toxic responses. Organized by classes of compounds and modeling purposes so users can quickly access information, this is the first comprehensive reference of its kind. Physiologically-based pharmacokinetic (PBPK) modeling has become increasingly widespread within the pharmaceutical industry over the last decade, but without one dedicated book that provides the information researchers need to learn these new techniques, its applications are severely limited. Schematic overview of the PBPK model for BPA, BPS, BPF, and BPAF and their glucuronides and sulfates (PBPK-compartments in gray, single-compartment submodules with dotted lines). The perorally ingested bisphenols are presystemically metabolized in the gut and in the liver to the respective metabolites. On receiving positive feedback on the first phase, Simulations Plus (NASDAQ:SLP) has entered accelerated second phase of its collaboration with a large pharmaceutical company to modify its high “Throughout a drug’s life cycle, PBPK model predictions can be used to support decisions on whether, when, and how to conduct certain clinical pharmacology studies, and to support dosing recommendations in product labeling.” The Simcyp Difference PBPK modeling allows predictions of local and systemic API concentrations following the integration of in vitro measurements on critical quality and performance attributes directly into the model structure or by establishing in vitro-in vivo correlations (IVIVCs) for drug products for which in vitro data on formulation characterization and pharmacokinetic data are available.

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