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课程主页: https://www.udemy.com/course/in-vitro-studies-for-solid-oral-dosage-forms-in-pharma/
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课程名称：药品固体口服剂型的体外研究 课程概述： 本课程聚焦于新药申请(NDA)与简化新药申请(ANDA)中的体内(生物利用度或生物等效性数据)与体外溶出数据。体内和体外的溶出数据，以及化学、生产和控制(CMC)数据，对于表征药品质量与性能至关重要。体外溶出方法的开发旨在评估固体口服剂型的体内生物性能。体外溶出测试不仅是产品生产一致性的质量控制测试，也是预测药物在生物环境中的性能的重要控制工具。该测试在实验室条件下进行，模拟体内条件，从而在没有进行体内试验的情况下评估药品的性能。课程全面讨论了溶出分析的所有技术细节和要求。 课程内容包括： 1. 课程介绍 2. 药品的体外与体内研究 - 参考列药(RLD)与仿制药 - 药物开发 - 药品的体外与体内性能 3. 溶解度 - 药物产品的溶解度 - 溶解度与溶出 4. 溶出及溶出选择性 - 溶出仪器 - 溶出变数的影响 - 粒度分布及多晶型结构对溶出的影响 - 辅料成分及其对溶出的影响 - 关键工艺参数对溶出的影响 5. 溶出测试作为工具 - 作为配方开发工具 - 作为质量控制工具 6. 溶出测试方法 - 溶出装置和搅拌速率 - 溶出体积与沉降条件 - 溶出介质及表面活性剂的使用 - 采样技术 - 溶出的关键问题 7. 溶出测试结果的评估 - 溶出结果与相似性因子 8. 溶出方法的选择性 9. 药品开发中的溶出 - 溶出在药品开发中的应用 - 鉴别性溶出方法的开发 10. 国际会议(ICH)中的溶出 - 即时释放与延迟释放片剂的溶出 11. 课程总结 该课程内容详实，适合药物研发和质量控制领域的专业人士学习，深入了解固体口服剂型的体外研究方法及其重要性。
New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) submissions contain in-vivo (bioavailability or bioequivalence data) and in-vitro dissolution data.In-vivo and in-vitro dissolution data, together with chemistry, manufacturing, and controls (CMC) data, are so important to characterize the quality and performance of the drug product.In-vitro dissolution methods are developed to evaluate the in-vivo bioperformance of solid oral dosage forms.In-vitro dissolution methods are quality control tests to ensure the consistency of product manufacturing and the bioperformance of solid oral dosage forms.Dissolution test is the simulation of in-vivo conditions in the in-vitro environment.Dissolution test is so important control tool because it is used for evaluating of in-vivo performance of drug product without any in-vivo performance.Dissolution test is developed and performed in laboratory conditions (in-vitro conditions). Dissolution test is kind of simulation in lab conditions. Dissolution test is usefull to foresee the performance of drug products in biological environment (in-vivo conditions).In the scope of course all technical details and requirements of dissolution analysis have been discussed.IN-VITRO STUDIES FOR SOLID ORAL DOSAGE FORMS IN PHARMA 1 Introduction 2 In-vitro & In-vivo Studies for Drug Product 2.1. Reference Listed Drug (RLD) & Generic Drug 2.2. Drug Development 2.3. In-vitro & In-vivo Performance of Drug Product 3 Solubility 3.1. Solubility of Drug Product 3.2. Solubility & Dissolution 4 Dissolution & Dissolution Selectivity 4.1. Dissolution-1 (Dissolution Instrument) 4.2. Dissolution-2 (Variations on CMA, CPP, Formulation Component & Dissolution Selectivity) 4.3. Dissolution-3 (Particle Size Distribution & Dissolution Selectivity) 4.4. Dissolution-4 (Polymorphic Structure & Dissolution Selectivity) 4.5. Dissolution-5 (Excipients Composition & Dissolution Selectivity) 4.6. Dissolution-6 (Critical Process Parameters & Dissolution Selectivity) 5 Dissolution Test as a Tool 5.1. Dissolution Method as a Formulation Development Tool 5.2. Dissolution Method as a Quality Control Tool-1 5.3. Dissolution Method as a Quality Control Tool-2 6 Dissolution Test Method 6.1. Dissolution Apparatus 6.2. Stirring Rate 6.3. Dissolution Volume & Sink Condition 6.4. Dissolution Media (Medium) & Surfactant Usage 6.5. Dissolution Sampling & Sampling Point & Sampling Apparatus 6.6. Critical Issues for Dissolution 7 Evaluation of Dissolution Test Results 7.1. Dissolution Results & Similarity Factor 8 Selectivity of Dissolution Method 8.1. Selectivity of Dissolution Method-1 8.2. Selectivity of Dissolution Method-2 8.3. Selectivity of Dissolution Method-3 8.4. Selectivity of Dissolution Method-4 9 Dissolution in Pharmaceutical Development 9.1. Dissolution in Pharmaceutical Development 9.2. Discrimitive Dissolution Method Development 10 Dissolution in ICH 10.1. Dissolution in ICH 10.2. Dissolution for Immediate Release Tablet 10.3. Dissolution for Extended Release Tablet 11 Conclusion
