What is Bioequivalence?
Generics are not required to replicate the extensive clinical trials that have already been used in the development of the original, brand-name drug. Since the safety and efficacy of the brand-name product has already been well established in clinical testing and frequently many years of patient use, it is scientifically unnecessary, and would be unethical, to require that such extensive testing be repeated in human subjects for each generic drug that a firm wishes to market. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner) to the pioneer drug. One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in 24 to 36 healthy, normal volunteers. This gives them the rate and extent of absorption-or bioavailability-of the generic drug, which they then compare to that of the pioneer drug. The generic version mu
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 ?
