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Applications of Gamma Scintigraphy in the Development of Oral Modified-Release Dosage Forms

机译:伽玛闪烁显像在口服修饰释放剂型开发中的应用

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Gamma scintigraphy can be applied to virtually all oral modified-release technologies and assists decision making during product development. Studies may be used to: 1. Visualize product performance in vivo 2. Focus the development strategy by providing early proof of concept data in man 3. Explore the mechanism of food effects 4. Demonstrate to regulatory authorities that the product is performing to its proposed rationale 5. Account for inter-subject variability in pharmacokinetic data 6. Overcome the poor predictability of in vitro studies for oral MR drug delivery systems.
机译:伽玛闪烁显像术几乎可以应用于所有口服调释技术,并有助于产品开发过程中的决策。研究可用于:1.可视化体内的产品性能2.通过提供有关人类的概念数据的早期证明来关注开发策略3.探索食物影响的机理4.向监管机构证明该产品对拟议产品的性能基本原理5.解释药代动力学数据中受试者间的变异性。6.克服口服MR药物递送系统体外研究的可预测性差。

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