Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, Rockville, Maryland 20855, USA.
Pharm Res. 2011 Jul;28(7):1445-53. doi: 10.1007/s11095-011-0397-6. Epub 2011 Mar 9.
The Office of Generic Drugs has ensured the high quality of generic products based upon two requirements: pharmaceutical equivalence and bioequivalence to the reference listed drug (RLD). This paradigm has been used with success toward ensuring quality generic drug products that provide the same therapeutic benefit as the RLD. Drug products have increased in design complexity; as a result, approaches to ensure therapeutic equivalence must evolve to provide assurance of quality generic drug products. The Food and Drug Administration quality by design initiative (QbD) provides an enhanced evaluation approach by introducing the concept of a quality target product profile (QTPP). The QTPP introduces, within the context of the current regulatory framework, the quality concept of "pharmaceutical equivalence by design." This article illustrates through several examples how this QbD element in the evaluation of modified-release drug products enhances the current framework to ensure generic drug product equivalence. It achieves this by complementing the traditional paradigm, "equivalence by testing," where product equivalence is based upon inferences from a limited bioequivalence study, to one that also considers whether the drug product was developed to be an equivalent to the RLD, using appropriate quality surrogates that target "pharmaceutical equivalence by design."
药学等效性和与参比上市药品（RLD）的生物等效性。这种模式已成功地用于确保提供与 RLD 相同治疗效果的高质量仿制药产品。药品的设计复杂性不断增加；因此，确保治疗等效性的方法必须发展，以提供高质量仿制药产品的保证。食品和药物管理局的质量源于设计倡议（QbD）通过引入质量目标产品概况（QTPP）的概念提供了一种增强的评估方法。QTPP 在当前监管框架的范围内引入了“设计等效性的质量概念”。本文通过几个例子说明了在评估缓释药物产品时，这一 QbD 要素如何增强当前的框架，以确保仿制药产品等效。它通过补充传统的“通过测试等效”模式来实现这一点，在该模式中，产品等效性基于对有限的生物等效性研究的推断，到考虑药物产品是否是为与 RLD 等效而开发的，使用适当的质量替代物来针对“设计等效性”。
