Key Points of Bioanalysis in Bioequivalence Study

To use bioequivalence study on consistency evaluation is the basis of the generic drug application. Pharmacokinetics is the optimal method used for evaluating bioequivalence. The most important aspect in pharmacokinetic is bioanalysis, which will directly affect the safety and effectiveness of drugs, and is also the key point for the results of bioequivalence study. Previous analytical results suggest that there is great room for improvement in data quality of bioanalysis carried out in our country. Thus, the aim of the study is to discuss the key points of method establishment, validation, testing, and recording in bioanalysis of bioequivalence based on the relevant guidelines and our actual work.