The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development
Pharmaceutical Technology
FEBRUARY 23, 2023
The BCS is a regulatory tool that is used to justify clinical biowaivers for certain types of compounds (BCS Class I and III) based on dissolution data, allowing sponsors to justify not performing clinical bioequivalence studies when changing a formulation. A recent example of this was for a compound at the candidate selection stage.
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