PBPK Modeling and Simulation, PK/PD Modeling and Simulation
An IVIVC (in vitro- in vivo correlation) is a mathematical relationship that predicts key pharmacokinetic parameters (Cmax, AUC) from in vitro dissolution data. Drug developers use IVIVCs for 3 major reasons:
1. To serve as a surrogate for human bioequivalence (BE) studies
2. To support and/or validate the use of dissolution methods and specifications
3. To assist in quality control during manufacturing and selecting appropriate formulations
My colleague, Dr. Nikunj Patel, has previously written on the Certara blog about mechanistic IVIVC models. In this blog post, I’ll discuss how to develop IVIVC models using the conventional approach.
Drug developers frequently use in vitro-in vivo correlations (IVIVCs) to: Serve as a surrogate for human bioequivalence (BE) studies. Support and/or validate the use of dissolution methods and specifications. Assist in quality control during manufacturing and selecting appropriate formulations. Conventional IVIVC uses deconvolution methods such as Wagner Nelson, Loo-Riegelman and numerical deconvolution to estimate the […]
Are you looking to support a bio waver for changes in manufacturing site, raw material suppliers and minor changes in formulation with Level A IVIVC? In this webinar, Dr. Terry Shepard of the Medicines and Healthcare product Regulatory Agency (MHRA) discussed the regulatory applications of IVIVC including the specification settings and biowaivers. She also explained […]