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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