Leeson L J, Adair D, Clevenger J, Chiang N
J Pharmacokinet Biopharm. 1985 Oct;13(5):493-514. doi: 10.1007/BF01059332.
A system is described for developing extended-release products, based upon predicting or simulating the entire plasma level-time curve to be expected from the administration of a controlled-release oral dosage form. Termed "biorelevant dissolution," it employs the product's in vitro dissolution behavior and the drug's pharmacokinetic parameters in conjunction with a classical pharmacokinetic model. The basic system is described along with some pertinent examples.
描述了一种用于开发缓释产品的系统，该系统基于预测或模拟从控释口服剂型给药预期的整个血浆水平-时间曲线。这种方法被称为“生物相关溶出度”，它结合了产品的体外溶出行为和药物的药代动力学参数以及经典的药代动力学模型。文中描述了基本系统以及一些相关示例。
