Regulations for Good Clinical Practice Article 68
If significant formulation changes are made in the investigational or comparator product(s) during the course of clinical development, studies about whether the new formulated product(s) significantly alter the stability, dissolution rate, bioavailability and other pharmacokinetic profile of the product(s) should be completed prior to the use of the new formulation in clinical trials.
中文原文 藥品優良臨床試驗作業準則第68條
臨床發展過程中試驗藥品或對照藥品之配方有重大改變者，應於新配方使用於臨床試驗前，完成新配方是否會明顯改變藥品安定性、溶離率、生體可用率及其他藥動學特性之研究評估。