Simulation Study on Multi-Regional Clinical Trial

• Main Authors: Hsu, Chia-Min, 許家敏
• Other Authors: Ou, Shyh-Tyan
• Format: Others
• Language: zh-TW
• Published: 2012
• Online Access: http://ndltd.ncl.edu.tw/handle/63636610571594847100

碩士 === 國立臺北大學 === 統計學系 === 100 === In the current drug development strategy, MRCT (Multiregional Clinical Trial) are increased to support the researchers as much as possible the use of the concept of global clinical trials to drug development and human trials. However, among various regions of the world, difference of races, genes, food culture, drug usages and clinical practices will have an impact on the efficacy and safety of drugs and dosage range. It is apparent to see drug lags occurred in the Asia region. How to shorten the length of drug lag becomes an important issue in Asia. It is a proper way to make use of the race similarity between Taiwanes and Japanese, we conduct BSE (Bridging Study Evaluation) to the approved new drug in Japan which the global clinical trials include Japanese. For those into the Japanese species of global clinical trials for the test sample, its approval of new drugs marketed in Japan, of BSE. This can effectively reduce the delay of the phenomena of drugs, the introduction of new drugs and a considerable degree of security. For this purpose, we have two methods currently used to assess whether new drugs are listed, the text known as Method 1 and Method 2, do the different conditions in-depth comparison and understanding, and the objective results of the simulation data, as paper the results of verification. Most importantly, of results, and look forward to as a reference for Taiwan's pharmaceutical regulatory agencies.