REGULATION AND GUIDELINE Study Design and Implementation for Population Pharmacokinetics of Chinese Medicine: An Expert Consensus

4 The medicines with toxicity and narrow therapeutic windows and with wide range of target population or with frequent adverse reactions were selected. The compositions with defi nite therapeutic effects were selected as frequent adverse reactions were selected. The compositions with defi nite therapeutic effects were selected as indices, and specifi c time points and sample sizes were designed according to standard PPK design methods. indices, and specifi c time points and sample sizes were designed according to standard PPK design methods. Target components were tested through various chromatography methods. Total quantity statistical moment Target components were tested through various chromatography methods. Total quantity statistical moment analysis was used to estimate PPK parameters of each component and PPK models refl ecting the trend of analysis was used to estimate PPK parameters of each component and PPK models refl ecting the trend of CMs (which assists in reasonable adjustments on clinical dosage). This consensus specifi es the study design CMs (which assists in reasonable adjustments on clinical dosage). This consensus specifi es the study design and implementation process of PPK. It provides guidance for the following: post-marketing clinical studies, and implementation process of PPK. It provides guidance for the following: post-marketing clinical studies, in vivo investigations related to the metabolism in different populations, and development and clinical adjustment investigations related to the metabolism in different populations, and development and clinical adjustment