活性成分為內源性物質的藥物（以下簡稱內源性藥物）的生物等效性（BE）研究應克服機體自身內源性水平對藥物濃度的影響，獲得藥物的凈效應，進而進行BE評價。研究的設計和開展應圍繞內源性水平的獲知、控制和校正等3個方面，并結合藥物的藥動學特征進行。梳理研究設計和實施、BE評價以及生物樣品分析等方面的技術要點和難點，同時結合氯化鉀緩釋片、左甲狀腺素鈉片等典型內源性藥物案例對上述技術要點進一步闡釋。國內發(fā)布的內源性藥物的指導原則較少，闡述內源性藥物生物等效性研究工作中的特殊性，總結其中的技術要點和挑戰(zhàn)，期望對此類藥物的BE研究提供一定參考。

The bioequivalence study of drugs with endogenous substances as active ingredients (endogenous drugs) should minimize the influence of the endogenous substance on drug concentration, obtain the net effect of drugs and evaluate the bioequivalence. The study should design and carry out according to the pharmacokinetic characteristics of the drug, and focus on obtaining, control, and correction of endogenous levels. This article summarizes the difficulties and technical points in research design, bioequivalence evaluation, and biological samples analysis. Typical cases such as Potassium Chloride Sustained-release tablets and Levothyroxine Sodium tablets are described to further explain. There are relatively few domestic guidelines released for endogenous drugs. This article describes the unique aspects in endogenous drug bioequivalence research, summarizes the key points and technical challenges, in anticipation to provide reference for the bioequivalence research of endogenous drugs.

R969.1