贝叶斯法评价药物制剂生物等效性的实验及其应用

Use of Bayesian method in bioequivalence assessment

本文介绍了贝叶斯法的基本原理及有关公式。以双氯芬酸钠普通注射剂和冻干注射剂为实验药物，给予１２名健康受试者分别肌内注射两制剂一次剂量（７５ｍｇ）后，于高效液相色谱中测定血浆药物浓度，计算药物动力学参数ＡＵＣ、Ｃｍａｘ和Ｔｍａｘ值。以这３个动力学参数为基本数据。

In this paper the primary theory and formularies of Bayesian method were introduced.After intramuscular injection of two formulations of diclofenac sodium (solution 75mg/3ml and lyophilized 75mg/+1ml) in twelve healthy volunteers,the plasma concentration was determined by HPLC.The pharmacokinetic parameters AUC、T max and C max were calculted.The experimental procedure and bioequivalence assessment were described with Bayesian method.