基于风险的抗癫痫药物生物等效性推荐。
Risk-Based Bioequivalence Recommendations for Antiepileptic Drugs.
机构信息
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA.
出版信息
Curr Neurol Neurosci Rep. 2017 Sep 19;17(11):82. doi: 10.1007/s11910-017-0795-1.
PURPOSE OF REVIEW
This review summarizes the current FDA practice in developing risk- and evidence-based product-specific bioequivalence guidances for antiepileptic drugs (AEDs).
RECENT FINDINGS
FDA's product-specific guidance (PSG) for AEDs takes into account the therapeutic index of each AED product. Several PSGs for AEDs recommend fully replicated studies and a reference-scaled average bioequivalence (RS-ABE) approach that permit the simultaneous equivalence comparison of the mean and within-subject variability of the test and reference products. The PSGs for AEDs published by FDA reflect the agency's current thinking on the bioequivalence studies and approval standards for generics of AEDs. Bioequivalence between brand and generic AED products demonstrated in controlled studies with epilepsy patients provides strong scientific support for the soundness of FDA bioequivalence standards.
目的综述
本文总结了美国食品药品监督管理局（FDA）目前在制定基于风险和证据的抗癫痫药物（AED）产品特异性生物等效性指导原则方面的实践。
最近的发现
FDA 的 AED 产品特异性指导原则（PSG）考虑了每种 AED 产品的治疗指数。FDA 发布的几项 AED PSG 建议进行完全复制研究和参考标度平均生物等效性（RS-ABE）方法，该方法允许同时比较受试和参比产品的均值和个体内变异性的等效性比较。FDA 发布的 AED PSG 反映了该机构目前在 AED 仿制药的生物等效性研究和审批标准方面的想法。在癫痫患者的对照研究中证明的品牌和 generic AED 产品之间的生物等效性为 FDA 生物等效性标准的合理性提供了强有力的科学支持。
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