Regulations of Bioavailability and Bioequivalence Studies Article 18
The data should be transformed using a logarithmic transformation prior to ANONA analysis at the 5% significance level, and then the treatment effect in 90% confidence interval is calculated.A 90% confidence interval is obtained from the log-transformed of the parameters under statistical consideration in bioavailability assessment. This confidence interval is then back-transformed to obtain the desired confidence interval on the original scale. The 90% confidence interval for the ratio of the test and reference products should be contained within the acceptance interval of 80.00-125.00%. For drugs with high intrasubject variability and not classified with narrow therapeutic index, the acceptance criteria for the confidence interval of Cmax can be widened to 0.75 to 1.33; in such case, the implication of international guidelines and clear statement in the study protocol will be required.
中文原文 藥品生體可用率及生體相等性試驗作業準則第18條
參與統計分析之生體可用率參數，應取對數值先進行變異數分析（ANOVA），其α值設定為零點零五，再計算藥品效應（TreatmentEffect）之百分之九十信賴區間（90％ConfidenceInterval）。
參與統計分析之生體可用率參數，全部以對數值計算百分之九十信賴區間，其取反對數值之百分之九十信賴區間，原則上應於零點八至一點二五之間。
藥品具個體內高變異性且非屬療效濃度範圍狹窄者，於符合國際規定並於計畫書中事先載明時，其最高血中濃度（Cmax）得放寬至零點七五至一點三三之間。
參與統計分析之生體可用率參數，全部以對數值計算百分之九十信賴區間，其取反對數值之百分之九十信賴區間，原則上應於零點八至一點二五之間。
藥品具個體內高變異性且非屬療效濃度範圍狹窄者，於符合國際規定並於計畫書中事先載明時，其最高血中濃度（Cmax）得放寬至零點七五至一點三三之間。