There is a constant interest in the study of drugs that are analogs of endogenous compounds. Guidelines for conducting bioequivalence studies are being updated. Official regulators are holding seminars on the development and study of generic drugs. The goal of the present study is to analyze approved protocols of clinical bioequivalence studies with an adaptive design for drugs that are analogs of endogenous compounds for the period 2015 – 2023. Nine bioequivalence protocols were analyzed. All protocols contained information on the determination of the endogenous background of the analyte being studied and the method for correcting it. An adaptive design did not need to be chosen because information was available on the variability of the studied endogenous compounds. Non-standard designs of the bioequivalence research could be considered for analogs of endogenous compounds, e.g., studies of the comparative pharmacokinetics with a detailed determination of the endogenous levels and with the use of pharmacodynamic endpoints.

人们对内源性化合物类似物的药物研究一直感兴趣。正在进行生物等效性研究的指南正在更新。官方监管机构正在举办有关仿制药开发和研究的研讨会。本研究的目标是分析 2015 年至 2023 年期间已批准的临床生物等效性研究方案，并对内源性化合物类似物的药物进行适应性设计。分析了 9 个生物等效性方案。所有方案均包含有关确定所研究分析物的内源背景及其校正方法的信息。不需要选择适应性设计，因为可以获得有关所研究的内源化合物的变异性的信息。对于内源性化合物的类似物，可以考虑生物等效性研究的非标准设计，例如，通过详细测定内源性水平并使用药效学终点来研究比较药代动力学。