On confidence limits associated with chow and shao's joint confidence region approach for assessment of bioequivalence

摘要

Confidence limits associated with Chow and Shao's 90 joint confidence region method (Camp;S CR limits) were derived to assess the bioequivalence (BE) of drug products. The Camp;S CR method provides three conditions that must be simultaneously satisfied to conclude BE,which is applicable only for raw scale data. The Camp;S CR limits method extends its applicability to both raw scale and log-transformed data. In addition, it is easy to interpret. The quantitative limits provide information, such as how much the test product deviates from the reference product in bioavailability. The data sets of peak plasma concentration (Cmax) and area under plasma concentration curve (AUC) of 13 BE studies involving 10 drugs were used to compare the performance of classic confidence interval (classic CI), Camp;S CR, and Camp;S CR limits method. The results indicate that the same BE conclusion can be reached for Camp;S CR and Camp;S CR limits methods. The Camp;S CR and its limits method offered a distinctive advantage in terms of percentage passing the BE criteria by taking account of the correlation and variability of simple means. Similar BE conclusion was observed for Camp;S CR limits method by using raw and log-transformed data in this study.