Computer Simulation to Evaluate the Factors Affecting Bioequivalence

• Main Authors: Kao Hau-Yun, 郭浩雲
• Other Authors: 許明照
• Format: Others
• Language: zh-TW
• Published: 1998
• Online Access: http://ndltd.ncl.edu.tw/handle/10261909945463382648

碩士 === 台北醫學院 === 藥學研究所 === 86 === In the bioequivalence test of insoluble drug, differences have the biggest chance to come out in the process of drug dissolving. The small diversity of treatments affects dissolution rate by particle size and distribution. The influence that the change of particle size has on bioequivalence is the theme of this research. We design a computer program to simulate the procedure of dissolution and absorption so that we can plot the plasma concentration curve and by this way achieve the objective of this research. The sampling of volunteers is also completed by the computer program. The result reveals that it has more opportunity to pass the bioequivalence test when we have more solubility, less diversity of volunteers and less diversity of particle size. But they are only significant on some ranges instead of having liner relationship. We also conclude that the program simulating is the better method to find the direction of all adjustable parameters and to reduce trial and error when we try to raise the probability of passing bioequivalence tests.