OGD Experience and Efforts on Oral Absorption Modeling and Simulation
FDA仿制药办公室OGD在机制性口服吸收建模与模拟的经验和成就
Xinyuan(Susie) Zhang
Office of Generic Drugs
导读：5月19日，美国FDA仿制药部OGD举办“口服建模与模拟在制剂开发与BE评价应用培训班”， FDA仿制药办公室Xinyuan Zhang博士阐述了OGD在机制性口服吸收建模与模拟的经验和成就。Xinyuan Zhang博士分享了：1）仿制药办公室OGD在吸收模型建模与模拟的进展2）应用案例-Evaluate the impact of slow dissolution in a specific pH condition on BE (warfarin sodium tablets)-Evaluate the PPI impact on BE (prasugrel HCl tablets, fingolimod capsules)3）GDUFA 基金对提高口服吸收模型的建模与模拟的影响总结：1）OGD已经将基于机制吸收模型的建模与模拟纳入到常规的法规监管活动中2）OGD正积极地改善固体口服制剂预测科学3）OGD愿意与内部和外部利益相关者合作，在药物产品开发和管理评审中促进机制性吸收模型的建模和模拟的应用。Xinyuan Zhang 博士的部分相关文章及Poster1）Modeling and Simulation of Biopharmaceutical Performance2）The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation3）Utility of Physiologically Based Absorption Modeling in Implementing Qualityby Design in Drug Development4）Application of Physiologically Based Absorption Modeling forAmphetamine Salts Drug Products in Generic Drug Evaluation5）Physiologically Based Absorption Modeling to Study Food Effects for a BCS II Drug6）Computational Simulation aided Bioequivalence Study Design for an Antiepileptic Drug
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