2017年6月12日 · 高变异性药物 (highly variable drug，HVD)的生物等效性 (bioequivalence，BE)研究是我国进行 仿制药质量与疗效一致性评价的重点内容之一。 HVD具有治疗窗宽、品种数目多、治疗领域广等特点。 由于其个体内变异大、生物不等效性风险高，导致研究难度大。 鉴于此，本文旨在综述国内外药品监督管理机构FDA，EMA和CFDA等对HVD临床BE试验技术指导原则内容，比较不同国家对HVD的BE试验临床评价要求，包括试验设计、样本量 …

Highly variable drug products (HVDP) are drugs whose rate and extent of absorption shows large dose-to-dose variability within the same subject. HVDP’s are generally defined as those drugs whose intra-patient coefficient of variation (Cmax and/or AUC) is approximately 30% or greater.

高变异药物（highly variable drug,HVD）是指在生物等效性试验中获得的个体内的变异（Within-subject coefficient of variance,CVw%）大于或等于30%的药物或参比制剂的PK参数（如Cmax/AUC0-t/AUC0-∞）个体内的标准差σWR≥0.294。

Highly variable drugs (HVDs) are those whose within-subject variability (WSV) for a parameter is larger than 30.00%. Itraconazole, a broad-spectrum triazole antifungal agent, is HVD with low bioavailability (55.00%).

BE for highly variable drugs (HVD) using reference-scaled average bioequivalence (RSABE) • RSABE: when within-subject variability (WSV) of the reference product is > 30% CV

高变异性药物 (highly variable drug,HVD)的生物等效性 (bioequivalence,BE)研究是我国进行仿制药质量与疗效一致性评价的重点内容之一.HVD具有治疗窗宽,品种数目多,治疗领域广等特点.由于其个体内变异大,生物不等效性风险高,导致研究难度大.鉴于此,本文旨在综述国内外 ...

Purpose: To explore the comparative performance of the recently proposed bioequivalence (BE) approaches, FDA (s) and EMA (s), by the FDA working group on highly variable drugs and the EMA, respectively; to compare the impact of the GMR-constraint on the two approaches; and to provide representative plots of % BE acceptance as a function of ...

2025年2月28日 · HvD pose a unique challenge in generic drug development due to their high intra-subject variability (CV > 30%) in pharmacokinetics. This variability complicates BE studies, requiring different regulatory agencies to adopt distinct approaches to ensure therapeutic equivalence without clinical hurdles.

Purpose: To establish procedures for the effective evaluation of bioequivalence (BE) for highly-variable drugs and drug products (HVD/P). Methods: 2- and 4-period crossover BE studies with 24 subjects were simulated which generally assumed within-subject coefficients of variation of …

For some drugs, due to low bioavailability, acid instability, extensive metabolism before absorption and the other reasons, the within-subject coefficient of variation (CVW%) of one or more pharmacokinetic parameters is greater than or equal to 30%, called highly variable drug (HVD).