| 摘要: | As indicated in a recent report(1), there are many issues in the assessment of bioequivalence(BE) which are remained unresolved. These issues include the applicability of the +/- 20% rule for all drug products, the potential use of female subjects in BE studies, drug interchangeability including prescribability and switchability and intrasubject variability associated with safety. In addition, the follows are some thoughts regarding the concept of criteria and statistical methodol-ogy for assessment of BE.
近來的一些論文與報告中，許多對生體相當性的論述仍是無解的。這些討論是包含對所有藥物生產的20%法則的應用，與用女性為主體在BE上的研究，藥物互換性相關於安全性的包含藥方，可轉換性與物體內的變異性。除此，本篇針對生體相等性上一些制的觀念和一些統計方法加以討論。 |
