The Evaluation of Average Bioequivalence Using a Modified Anderson-Hauck’s Test

• Main Authors: Wei-Hang Chen, 陳韋翰
• Other Authors: Mi-Chia Ma
• Format: Others
• Language: en_US
• Published: 2005
• Online Access: http://ndltd.ncl.edu.tw/handle/19755705224003622903

碩士 === 國立成功大學 === 統計學系碩博士班 === 93 === Only after the patent of a brand-name innovative drug product is expired, its generic copies are allowed to market. However, regulatory approval requires evidence of bioequivalence based on the pharmacokinetic responses derived from the time-plasma concentration curve of the active ingredients. Currently, about the evaluation of interval hypotheses testing of average bioequivalence, Schuirmann’s two one-sided tests and Anderson and Hauck’s test would be introduced. However, there exists some problem within the Anderson and Hauck’s test. It need to calculate the noncentrality parameter in test statistics. The Bootstrap resampling method is introduced to perform the empirical distribution. The real test statistics distribution is performed by a simulation study on the various combinations of parameters and sample size under 2 2 crossover design. The simulation study was conducted to empirically examine and compare the size and power of the original test and our proposed four methods. In the simulation study, we also recommend exponential distribution, uniform distribution and Cauchy distribution to replace with the normal distribution.