Bioequivalence Assessment
Bioequivalence focuses on the equivalence of release of the active pharmaceutical ingredient from the pharmaceutical product and its subsequent absorption into the systemic circulation. This session has utmost importance in context to the fact that only a suitably bioequivalent drug candidate that conforms the results in all respects to the original licensed product can be called as biosimilar drug.
Of all attempts towards developing a follow on biologics or a biosimilar drug the main detection point stands at the bioequivalence assessment. Once the bioequivalence has been obtained it can be 70% ascertained the drug qualifies to be a suitable biologics or biosimilars.
- Strategies for the bioequivalence assessment of topical dosage forms
- Bioequivalence approaches for transdermal dosage forms
- Bioequivalence assessment of respiratory dosage forms
- Evaluation of highly variable drugs and drug products
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Bioequivalence Assessment Conference Speakers
Recommended Sessions
- BCS and IVIVC Based Biowaivers
- Bioequivalence Assessment
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