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