Bioequivalence & Dissolution Studies Training Course
- 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.
- 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.