What is Bioequivalence Study?
Bioequivalence simply means a generic drug has the same therapeutic effect with that of the originator drug based on clinical tests performed and presented by trustworthy research institutions. Birkett defined bioequivalence by stating that, “two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilities (rate and extent of availability) after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same.
Related Questions
- What indicates the period effect and sequence effect in a typical 2-way crossover bioequivalence study with a proper washout period?
- Why randomization is required for a typical Bioequivalence study (open label, cross over, balanced study)?
- Can the IP’s shipped to the CRO before the IRB approval for a typical Bioequivalence study ?
