Deformulation and its relevance to bioequivalence studies

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In this webinar, Dr Paul Senior, a Method Development & Validation expert from Concept Life Sciences, and Dr Paul Kippax, the Pharmaceutical Sector Director from Malvern Panalytical, will demonstrate the importance of deformulation or ‘reverse engineering’ to elucidate the analytical approaches that can be applied in the detection of active pharmaceutical ingredients (APIs) and excipients. They will show how assessment of the physicochemical properties of APIs and excipients present in formulations is critical when developing equivalent generic formulations, detailing the role of deformulation in formulation deconstruction and reconstruction to ensure bioequivalence of generic products.

発表者

  • Dr Paul Kippax
  • Dr Paul Senior

詳細

Learning objectives:

  • Find out what deformulation is and why it’s important
  • Understand the role of deformulation prior to a bioequivalence study
  • Learn the criteria to consider in the separation of formulation components
  • Learn about analytical approaches from real case studies

This webinar will benefit:

  • Formulation scientists
  • Pharmaceutical scientists interested in deformulation
  • Researchers working on formulation development