国际药物制剂研发流程.ppt

Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,国际药物产品分类及市场独销,创新药,-5,年,NDA,创新制剂,-3,年,NDA,仿制药,-0.5,年（首仿）,ANDA,孤儿药,-7,年,DESI,药,-3,年,创新药品研发流程,Drug Discovery,临床前研究,申报临床试验（,IND,）,临床一期研究,临床二期研究,临床三期研究,申报新药（,NDA,）,创新药物研发的主要障碍,药物制剂技术研发策略管理,创新药：常规制剂技术,产品生命周期（,LCM,）,:,创新制剂技术,创新制剂产品：创新制剂技术,药物制剂研发管理,Discovery Support,Preformulation,Formulation Development-QbD,Process Development,Process Validation,PAT,ICH Q10,Preformulation Report,1.,Summary,2.Test Conditions,2.1.Compatibility of API in binary mixtures with excipients,2.2.Solubility test in selected solvents and vehicles,2.3.HPLC method,2.4.Other investigations,3.Results,3.1.Compatibility of API in binary mixtures with excipients,3.2.Solubility test in selected solvents and vehicles,4.Conclusions,4.1.Discussion of the results and conclusions,4.2.Further compatibility studies,if needed/recommendation CF development,5.References,Attachments,1.Batch numbers of the excipients used,2.Compositions of the mixtures of excipients,3.HPLC results,main effects and interactions,4.Interpretation of interactions,5.Binary mixtures,HPLC results,制剂研发,Composition,Primary packaging material,Manufacturing procedure,Flow Chart,Equipment,Safety Measures,Specifications,（,IPC,，,release,）,Shelf life,References,MSDS,Tooling Drawings,Master Batch Record,药物制剂研发,-,管理节点,原料药：临床一期，有关物质，生产工艺,稳定性研究,产业化工艺,申报临床试验,-IND,（预会议）,临床试验：不同阶段制剂技术,PK,研究很重要，联系上已有临床试验结果,产品技术转移,申报新药,-NDA,生产工艺验证,批准上市,产品生命周期延长,-LCM,制剂研究策略和要点,Quality by Design,：确定影响质量的因素,制剂研究总结：包括各阶段的开发经历（,Development Pharmaceutics,）,毒理、,PK,、和临床所用原料药的来源及批号,毒理、,PK,、和临床实验所用制剂配方,制剂参数：极限实验,体内体外相关性,产品生产工艺开发经历,“,新辅料”或 “新技术”,全球原料药、辅料、及产品供应,生产工艺验证,每一个新产品的生产工艺均要验证,验证的主要文件,验证总体规划,验证方案,验证结果,验证的材料要提供给政府有关,GMP,部门审查,TECHNOLOGY ACCEPTANCE,Formal Acceptance of manufacturing technology,Checklist to Ensure Registration Documents are Available,Used to Answer Questions/Proposed Changes of Regulatory Authorities Prior and Post Approval,Statement on Robustness/Weakness of the Product(Reservations),Starts Production Change Control Process,Identifies Local Production Instructions(Batch Record),谢谢,!,