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 the implications of:

  • Choice of IR reference formulation
  • IVIVC study design
  • MR formulation programme design
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