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Improve Your Success Rate in Costly Bioequivalence Studies with IVIVC

On-Demand Webinar

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

About Our Speakers

Venkateswari Muthukrishnan, Senior Scientific Consultant, Certara. Dr. Venkateswari Muthukrishnan joined Certara in 2012. She is responsible for Training and Pre-sales Support in South Asia Pacific and Middle East. In addition, she provides Training and Support on Phoenix Products: Phoenix WinNonlin, NLME, Connect and IVIVC Toolkit. Prior to joining Certara, she held positions at a number of organizations including: AAI International, FibroGen Inc., Biocon Limited, Nektar Therapeutics India Pvt. Ltd., PharMantra Consulting Services, and BITS-Pilani (HYD).

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