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所在平台: Udemy |
课程主页: https://www.udemy.com/course/pharmaceutical-development/
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课程名称：CTD药物开发部分的准备 课程概述：药物开发的目标是设计出高质量的产品及其制造工艺，以持续提供预期的产品性能。药物开发研究和初始批次的制造是建立成品药物关键质量属性(CQAs)和制造过程关键工艺参数(CPPs)的科学和风险评估方法的重要组成部分。课程中获取的信息和知识将为制定规格及制造控制提供科学支持。该课程为希望进入制药行业的人士和希望在工作中进一步发展的现有制药专业人士提供了关于通用（多源）药品药物开发计划内容的信息、评估和解释。 课程内容： 1. 药物开发的指南范围 - CTD（通用技术文件） - ICH Q8 药物开发 - WHO 多源（通用）成品药物的药物开发 - 质量模块 3.2.P.2 的范围 2. 药物开发的一般定义 - 活性药物成分（API） - 成品药物（FPP） - 控制策略 - 参考上市药物（RLD） - 固定剂量组合成品药物（FDC-FPP） - 通用（多源）药品 - 药物替代品 - 药物等效性 - 治疗等效性 - 关键工艺参数（CPP） - 关键质量属性（CQA） - 质量目标产品概况（QTPP） 3. 药物开发 - 活性药物成分的药物开发 - 活性药物成分的理化性质 - 溶解度 - 渗透性 - 生物药物分类系统（BCS）分类 - 粒径分布（PSD） - 多晶型结构 - 固态表征 4. 药物开发中的降解研究 - 兼容性（降解）研究 - 兼容性（降解）研究中的应力因素 - 药物开发中的兼容性（降解）研究 - 应力（强制降解）研究 - 兼容性（降解）研究与应力（强制降解）研究的比较 5. 辅料 6. 功能相关特性 - 功能相关特性的定义 - 填料的功能相关特性 - 黏合剂的功能相关特性 - 崩解剂的功能相关特性 - 聚乙烯吡咯烷酮（PVP）的功能相关特性 - 崩解剂的功能相关特性评估 7. 药物开发中的辅料 8. 药物产品的药物开发 9. 溶解度 - 溶解度和溶出度 - 溶出度测试（体外与体内相关性） - 溶出度测试的定义 - 溶出度测试的目的 - 溶出方法的选择性 - ICH Q6A 中的溶出度 - ICH Q6A 中的即时释放 - ICH Q6A 中的缓释 10. 药物开发中的溶出度 - 药物开发中的溶出度 - IR片剂的溶出规格 - 缓慢溶解IR片剂的溶出规格 - ER片剂的溶出规格 11. 药物开发中的制造方法开发 - 制造方法选择 - 制造方法开发 本课程适合所有希望进入制药行业的人士或希望在其职业生涯中进步的现有制药专业人士。
The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The pharmaceutical development studies and the manufacture of primary batches are essential elements for the science and risk-based approach to establish the critical quality attributes (CQAs) of the finished pharmaceutical product and the critical process parameters (CPPs) of the manufacturing process. The information and knowledge gained from pharmaceutical development studies provide scientific understanding to support the establishment of specifications and manufacturing controls. This course provides informations, evaluations, and explanations on the contents of a pharmaceutical development plan for generic (multisource) pharmaceutical products for anyone who is looking to get entry in pharmaceutical industry and existing pharma professionals who are looking to progress in their jobs. The pharmaceutical development section in registration product dossier should also contain information on the development studies conducted to establish that the dosage form, formulation, and manufacturing process. These studies have been also explained and detailed in the scope of this Preparation of Pharmaceutical Development Part for CTD course.COURSE CONTENT1. GUIDELINE SCOPE FOR PHARMACEUTICAL DEVELOPMENT -CTD (Common Technical Document) -ICH Q8 Pharmaceutical Development -WHO, Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products -Scope of Quality Modül 3.2.P.2.2. GENERAL DEFINITIONS FOR PHARMACEUTICAL DEVELOPMENT -Active Pharmaceutical Ingredient (API) -Finished Pharmaceutical Product (FPP) -Control Strategy -Reference Listed Drug (RLD) -Fixed-Dose Combination Finished Pharmaceutical Product (FDC-FPP) -Generic (Multisource) Pharmaceutical Products -Pharmaceutical Alternatives -Pharmaceutical Equivalence -Therapeutic Equivalence -Critical Process Parameter (CPP) -Critical Quality Attribute (CQA) -Quality Target Product Profile (QTPP) 3. PHARMACEUTICAL DEVELOPMENT 3.2.p.2.4. ACTIVE PRODUCT INGREDIENT FOR PHARMACEUTICAL DEVELOPMENT -Physicochemical Properties of Active Product Ingredient -Solubility -Permeability -Biopharmaceutical Classification System (BCS) Classification -Particle Size Distribution (PSD) -Polymorphic Structure -Solid State Characterization5. DEGRADATION STUDIES IN PHARMACEUTICAL DEVELOPMENT -Compatibility (Degradation) Studies -Stress Factors in the Compatiblity (Degradation) Studies -Compatibility (Degradation) Studies in Pharmaceutical Development -Stress (Forced Degradation) Studies -Comparison of Compatibility (Degredation) Studies and Stress (Forced Degradation) Studies 6. EXCIPIENTS7. FUNCTIONAL RELATED CHARACTERISTICS -Definition of Functional Related Characteristics -Functional Related Characteristics for Fillers -Functional Related Characteristics for Binders -Functional Related Characteristics for Disintegrants -Functional Related Characteristics of Polyvinylpyrolidone (PVP) -Evaluation of Functional Related Characteristics of Disintegrants8. EXCIPIENTS IN PHARMACEUTICAL DEVELOPMENT 9. DRUG PRODUCT IN PHARMACEUTICAL DEVELOPMENT 10. DISSOLUTION -Solubility -Solubility & Dissolution -Dissolution Test (In-vitro & In-vivo Correlation) -Definition of Dissolution Test -Aims of Dissolution Test -Selectivity of Dissolution Method -Dissolution in ICH Q6A -Dissolution in ICH Q6A - Immediate Release -Dissolution in ICH Q6A - Extended Release11. DISSOLUTION IN PHARMACEUTICAL DEVELOPMENT -Dissolution in Pharmaceutical Development -Dissolution Specification for IR Tablet -Dissolution Specification for Slowly Dissolving IR Tablet -Dissolution Specification for ER Tablet12. MANUFACTURING METHOD DEVELOPMENT FOR PHARMACEUTICAL DEVELOPMENT -Manufacturing Method Selection -Manufacturing Method Development
