The EMA considers two comparator agents as bioequivalent, "if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities (rate and extent) after administration in the same molar dose lie within acceptable predefined limits" (EMA 2010).
Birkett (2003) 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.
The generic manufacturer must show that the generic drug is bioequivalent to the reference drug, meaning they contain the same active moiety and that their bioavailabilities (rate and extent) after administration in the same molar dose lie within acceptable predefined limits 6. Toxicology and clinical efficacy studies are not required.
Clinical application of curcumin for Alzheimer's disease treatment is severely limited with regard to its poor bioavailability, high rate of metabolism, and instability under neutral condition.
Several factors can affect Cmax, including bioavailability, absorption rate, volume of distribution, and drug clearance.
Our results showed that bioavailability (both rate and extent) of CsA in rabbits decreased significantly after oral treatment with Nigella sativa.
To explore 24-hour variation in the different PK parameters, IOV was sequentially incorporated on oral bioavailability, absorption rate constant, and systemic clearance (Supplementary Table 1).
Naproxen, a non-steroidal anti-inflammatory drug (NSAID), is a biopharmaceutics classification system (BCS) class II drug whose bioavailability is rate-limited by its dissolution.
Similarly to synthetic drugs, the exact crystalline form of active ingredients in solid formulations of dietary supplements may directly influence the dissolution rate, bioavailability, and stability of the final product, but this information is usually not provided by manufacturers.
