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Bioequivalence & Dissolution Studies Training Course

Bioequivalence & Dissolution Studies Training Course

Learning Objectives:

  • How to design a bioequivalence study.
  • Connecting the dissolution data to bioequivalence.
  • The requirements for bioequivalence studies under fasting and fed conditions.
  • Explaining the fundamental pillars for the bioanalytical method validation in the bioequivalence study.
  • The requirements for exemption from the bioequivalence studies (Biowaiver based on BCS).
  • Review the evaluation process of the bioequivalence study.
  • Presenting real cases regarding the bioequivalence and dissolution studies.

Topic Title:

  • Introduction to bioequivalence & the appropriate way to design a BE study.
  • Ideal bioequivalence documentation.
  • Regulatory aspects of dissolution studies.
  • The biowaiver concept according to SFDA guidelines.
  • The ways to make decisions in some cases (Different API suppliers and FPP manufacturers).
  • Requirements of batches that are used in the bioequivalence studies.
  • The scientific recourses (references) that should be checked before conducting bioequivalence study.
  • Major concerns in the bioequivalence & Dissolution studies supported by cases.
  • The key elements of bioanalytical method validation in the bioequivalence study.
  • The evaluation process of the bioequivalence study (Module 5): In depth knowledge for assessment pathway.

Training Cost

5100