Biological sample analysis mainly detects the blood concentration in bioequivalence experiment. Among them, bioequivalence (be) refers to the statistical difference of drug absorption degree and speed between test preparation and control standard preparation under the same test conditions. When the difference of absorption rate has no clinical significance, some drug preparations have the same degree of absorption, but different speed can also be considered as bioequivalence. The study of bioequivalence reflects the biological standard of drug preparations and provides direct evidence for clinical efficacy.
Bioequivalence is used to evaluate whether the effects (safety and efficacy) of two drugs on patients with a disease are the same or similar. For example, generic drugs and standard drugs, natural drugs and chemical drugs, oral drugs and injections, long-term drugs and short-acting drugs, the comparison of low-dose and high-dose of a drug needs to be evaluated by bioequivalence method. According to FDA, if the generic drug is bioequivalent to the registered drug, the application process can be carried out according to the abbreviated new drug application (anda) instead of the new drug application (NDA), which avoids the time-consuming and expensive phase II and III clinical trials. Therefore, bioequivalence test plays an important role in clinical trials of new drugs.
