Bioequivalence

Bioequivalency (BE) is the statistical difference in the extent and rate of absorption of a drug and the amount of exposure between a test formulation and a control standard formulation under the same test conditions. When the difference in absorption rates is not clinically significant, some drug formulations with the same degree of absorption but different rates may be considered bioequivalent. Bioequivalence is used to evaluate whether two drugs have the same or similar effects (safety and efficacy) on patients with a particular disease. For example, generic drugs and standard drugs, natural drugs and chemical drugs, oral drugs and injectable drugs, long-acting drugs and short-acting drugs, and low-dose and high-dose comparisons of a particular drug need to be evaluated by bioequivalence methods. FDA stipulates that if there is bioequivalence between a generic drug and a registered drug, the registration process can be carried out according to the abbreviated new drug application (ANDA) instead of the new drug application (NDA), which avoids time-consuming and costly phase Ⅰ and phase Ⅲ clinical trials under the prerequisite of guaranteeing the quality of R&D projects, as well as the scientificity and reasonableness of the research. Therefore, bioequivalence testing has a very important role in clinical trials.