Related Experiment Video
Updated: Jun 19, 2026

Coherent anti-Stokes Raman Scattering (CARS) Microscopy Visualizes Pharmaceutical Tablets During Dissolution
Published on: July 4, 2014
Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I
H Kortejärvi1, R Shawahna, A Koski
1Research and Development, Orion Pharma, Espoo, Finland.
Abstract:
Currently, the EMEA, FDA, and WHO as regulatory authorities accept rapidly dissolving (>85% dissolved in 30 min) biopharmaceutics classification system (BCS) I drug products for biowaiver candidates. In the draft EMEA guideline the requirement has been set tighter, that is, the drug product should be very rapidly dissolving (>85% dissolved in 15 min) to be eligible for a biowaiver. Pharmacokinetic modeling of 32 BCS I drugs was performed to demonstrate that very rapid dissolution is not necessary to guarantee bioequivalence for them. Rapid dissolution and similar dissolution profiles are sufficient criteria for all BCS I drugs.
Related Concept Videos
Bioequivalence studies: Biowaivers
Factors Influencing Drug Absorption: Drug Dissolution
Drug Dissolution: Requirements and Profile Comparison
Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems
Bioequivalence: Overview
Bioavailability Enhancement: Drug Solubility Enhancement
