Answers to Your Burning Questions on Level C IVIVC

Jean-Michel Cardot

In vitro-in vivo correlation (IVIVC) technology allows formulation and manufacturing (CMC) professionals to understand how dissolution parameters affect in vivo drug performance. IVIVC can be performed at one of three levels—A, B, and C. Getting the most out of this tool requires knowing when and how to use which level of IVIVC. Here are some […]

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Topics: PK/PD Modeling & Simulation

Level C IVIVC: What Is It, and When Do You Use It?

Jean-Michel Cardot

In vitro in vivo correlation (IVIVC) links in vitro drug data to in vivo performance. Regarding in vivo performance, IVIVC can predict either the in vivo plasma time-concentration curve or in vivo pharmacokinetic (PK) parameters like Cmax and AUC. In this blog, I will discuss Level C IVIVC, and when you should use this approach. […]

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Topics: PK/PD Modeling & Simulation

How to Perform Level C IVIVC in Phoenix

In this webinar, Professor Jean-Michel Cardot explained how to perform Level C IVIVC using Phoenix. Learn how to calculate pharmacokinetic parameters via the non-compartmental analysis module; how to calculate dissolution parameters via the dissolution module; how to link the in vivo pharmacokinetic parameters and in vitro dissolution parameters via the linear relationship module; and how to calculate dissolution limits.

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Mechanistic and Conventional IVIVC: Complementary or Clashing Approaches?

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 […]

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Improve Your Success Rate in Costly Bioequivalence Studies with IVIVC

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 […]

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