在臨床試驗第Ⅰ期的藥物動力學研究中，經常是針對志願受試者分別施予兩種藥物，一為檢驗藥，另一為參考藥。然後測量其服藥後血液中含有藥物的濃度，得到藥物濃度隨時間改變的側寫。最後，藉由具生物有效性的藥物濃度時間側寫下的面積（AUC）或最大藥物濃度值 ，推論這兩種藥物的生物相等性。鑑於上述測量值僅是藥物濃度時間側寫的函數，本研究直接根據此一側寫資料，在單區藥物動力學模型之下，建立多重檢定或兩種藥物平均濃度時間曲線差異的聯合信賴區間，檢測這兩種藥物是否具有生物相等性。本文除以模擬研究這二種方法與傳統利用AUC進行生物相等性檢定的型Ⅰ誤差率及檢定力外，最後分析一筆資料藉以說明這些方法的應用。 The pharmacokinetics study of clinical phaseⅠ trial, the two drugs are administered as volunteers. One is test drug and the other is reference drug. Then, the drug concentrations in blood and the concentration-time profile are obtained after administration drugs. Finally, the bioequivalence of two drugs is inferenced by area under the blood concentration cruve (AUC) or maximum blood concentration ( ). Seeing that the measured values are only the function of the drug concentration-time profile, this paper constructs a multiple testing or the simultaneous confidence-intervals of the two drugs concentration-time profile by directly using the measured values under the one-compartment model in a pharmacokinetics. Next, testing whether the two drugs have bioequivalence. In this paper, besides testing the type Ⅰerror and power of bioequivalence is using a simulation study which is conducted by above two methods and the traditional AUC method, using a data to illustrate the application of these methods.
