Here are the key points of the Bioequivalence Process
Writer & Editor : Andi Darmawan
Bioequivalence testing is a test conducted to ensure that two drug products have the same bioavailability, meaning they achieve the same concentration in the blood and provide the same therapeutic effect when administered at the same dose. This test is particularly important for generic drugs, to ensure that they have equivalent effectiveness and safety compared to the existing branded drug.
Here are the key points of the bioequivalence process :
- Proper Study Design
- Clinical Studies: Bioequivalence studies typically involve clinical trials with human subjects ...