关键词: font-size:medium, ">群体生物等效性；特殊制剂；Excel软件；布地奈德混悬液

Abstract: Objective：According to the guidelines of budesonide suspension issued by FDA， the bioequivalence of special preparations in vitro was calculated by Excel software. Methods： According to FDA guiding principle of population bioequivalence evaluation of budesonide suspension， based on the particle size data of budesonide in the guiding principle， the population bioequivalence results were calculated by using the function formula in Excel software， and compared with the results in the guiding principle. Results： The results of population bioequivalence of budesonide suspension calculated by Excel software are completely consistent with those in the guiding principles. The reference preparation is used to determine the population bioequivalence of the test parameters， with HηR<0. The tested preparation and the reference preparation are bioequivalent， and their efficacy and safety are consistent. Conclusion： It is very important to evaluate the bioequivalence of special preparations in vitro. Without professional software， Excel software can quickly and accurately calculate the bioequivalence of special preparations in vitro.

Key words: font-size:medium, ">Population bioequivalence；Special preparations；Excel software；Budesonide suspension