, N Potomac, Maryland, 20878, USA,
AAPS J. 2014 Jul;16(4):621-4. doi: 10.1208/s12248-014-9601-z. Epub 2014 Apr 17.
Principles of dissolution science have been applied to allow waiver of in vivo bioequivalence studies for oral immediate release solid dosage forms, providing certain stipulations are met. This approach reduces regulatory burden without sacrificing product quality and performance requirements that assure continuing equivalence. These principles are broadly applicable to other dosage forms and routes of administration. In this article, we postulate a further opportunity, which relies on a determination of "optimal performance" for nonsolution orally administered drug products. The determination can be applied to certain highly soluble and rapidly dissolving drug products without further study, paving the way possibly for even further reductions in regulatory burden.
溶解科学原理已被应用于口服即释固体制剂，允许豁免体内生物等效性研究，只要满足某些规定。这种方法在不牺牲产品质量和性能要求的情况下，减轻了监管负担，确保了持续等效。这些原则广泛适用于其他剂型和给药途径。本文提出了另一个机会，该机会依赖于对非溶液口服药物产品的“最佳性能”的确定。对于某些高溶解性和快速溶解的药物产品，可以在无需进一步研究的情况下进行确定，为进一步减轻监管负担铺平道路。
