监管生物等效性要求是否充分反映了缓释药物产品的治疗等效性？
Do regulatory bioequivalence requirements adequately reflect the therapeutic equivalence of modified-release drug products?
机构信息
Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada.
出版信息
J Pharm Pharm Sci. 2010 May 10;13(1):107-13. doi: 10.18433/j32g6p.
PURPOSE
To demonstrate that current regulatory requirements for bioequivalence (BE) do not always reflect therapeutic equivalence. To investigate the potential usefulness of an additional metric, the partial AUC.
METHODS
Pharmacokinetic information was reviewed and evaluated on the pharmacokinetics of modified-release methylphenidate and nifedipine products.
RESULTS
In studies of modified-release products of methylphenidate as well as of nifedipine, traditional regulatory criteria found two formulations to be bioequivalent even though their concentration profiles strongly diverged during the period of absorption. An additional metric, partial AUC, discriminated strongly between the concentrations of the drug products.
CONCLUSIONS
The current regulatory criteria for the acceptance of BE do not always reflect the therapeutic equivalence of modified-release drug products. With some modified-release products, the application of an additional metric, the partial AUC, yields an improved discriminatory representation.
目的
证明当前的生物等效性（BE）监管要求并不总是反映治疗等效性。研究一个额外指标——部分 AUC 的潜在有用性。
方法
对缓释型哌甲酯和硝苯地平产品的药代动力学信息进行了回顾和评估。
结果
在对缓释型哌甲酯和硝苯地平的研究中，尽管两种制剂在吸收期的浓度曲线有很大的差异，但传统的监管标准发现这两种制剂具有生物等效性。一个额外的指标——部分 AUC，在药物产品的浓度之间具有很强的区分能力。
结论
当前用于接受 BE 的监管标准并不总是反映缓释药物产品的治疗等效性。对于一些缓释产品，应用一个额外的指标——部分 AUC，可以得到更好的区分能力。
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