Interplay of Metabolism and Transport in Determining Oral Drug Absorption and Gut Wall Metabolism: A Simulation Assessment Using the “Advanced Dissolution, Absorption, Metabolism (ADAM)” Model
The Effect of IgG-FcRn Binding Stoichiometry on Simulated mAb Half-life Using a Minimal Human PBPK Model
Evaluating the Impact of Extended Release Formulations on Absorption and Gut-wall Metabolism Using a Physiologically-based Pharmacokinetic Simulation Approach
Comparison of the Catalytic Activity per Unit Enzyme of Recombinantly Expressed and Human Liver Microsomal Cytochrome P450 2C9: Determination of Inter System Extrapolation Factors
Using PBPK modeling, researchers predicted multiple-dose exposure levels and optimized the design of a DDI study for a compound exhibiting auto-inhibition.
Physiologically-based Modeling Supports Drug Development Decisions, Regulatory Interactions and Drug Labeling
Today’s powerful and actively evolving computational tools enable sponsors and regulators to understand potential drug characteristics and subject responses earlier in development, with greater certainty. Model-based approaches support timely, confident decisions across the development and regulatory life cycle by gathering disparate sources of information about a drug, its competitors, target disease and patients into a […]
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used as part of highly active antiretroviral therapy (HAART) for the treatment of a human immunodeficiency virus (HIV) type 1. It is primarily metabolized by CY2B6. A standard dose of efavirenz has been associated with serious adverse reactions in poor metabolizers (PMs) of CYP2B6, necessitating a reduction […]