新药分析方法的建立与验证
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MMTR – Microbiological Method Transfer Report
MDDS – Microbiological Development Documentation Set
5
上海浦融
ChamQuest
分析方法的生命周期(Life Cycle)
方法的建立
方法的验证
方法的转移
上海浦融
▪ 产品的安全性
Product safety
▪ 制剂的生物利用性
– Dosage form’s bioavailability
▪ 原料,中间体及产品规格的确定
– Spec setting for API, intermediates, and product
▪ 产品的有效期的确定
– Shelf-life of product
Knowledge Management
Quality Risk Management
4
上海浦融
ChamQuest
强生技术转移模式
Phase I
Phase I百度文库A Clinical Trials
Phase IIb
Early Development
Starting Point - (Sourcing Decision)
AMTR (In-Process Testing) – Analytical Method Transfer Report for in-process testing transfer AMTR – Analytical Method Transfer Report
ADDS - Analytical Development Documentation Set
– 输送技术开发 Delivery Development – 技术转移 Technology Transfer ▪ 申报与审批 (Regulatory filings)
上海浦融
ChamQuest
▪ 生产及商业运作 (Manufactu8ring & commercialization)
药品开发中分析测试的作用
Process Performance & Product Quality Monitoring System Corrective Action/Preventative Action (CAPA) System Change Management System Management Review
AMTR
ADDS
Micro Method Transfer
MMTR
MDDS
Development Reports
PTR
Transfer Signoff Acceptance
Timeline for Activity
Ongoing Activity (as required)
Report Name Abbreviations
▪ 制剂配方的优化
– Determining optimum formulation
▪ 杂质与降解物的定性,定量和“确认“
– ID, quantitation and “qualification” of impurities & degradants
Pre-Validation (Final Scale-Up
Activities)
Validation*
Launch
Outputs
TTPP PIR
PDIR
AMTR (In-Process testing)
Analytical Pre-Transfer
Analytical Method Transfer
Phase III Clinical Trials Full Development
File PAI
Filing and Launch Filing and Launch
End Point
Process
Development Activities TTS
Registration Batches (Phase III Clinical Trials)
分析方法的建立与验证
上海浦融生物科技有限公司 ChamQuest
1
分析方法的建立与验证
▪ 0. 引言 ▪ 1. 分析方法在药品开发中的应用 ▪ 2. 分析方法开发的基本问题 ▪ 3. 分析方法的验证与转移
上海浦融
ChamQuest
2
0. 引言
上海浦融生物科技有限公司 ChamQuest
3
药物质量体系
Pharmaceutical Development
Technology Transfer
Investigational Products
Commercial Manufacturing
Product Discontinuation
GMP
PQS elements
Enablers
Management Responsibility
▪ 临床研究 (Clinical) – I&II期临床试验 Clinical phase I&II – III期临床试验 Clinical phase III
▪ 化学与生产控制 (CMC)
– 化学开发 Chemical development – 药品开发 Pharmaceutical development – 分析开发 Analytical development – 工艺放大 Scale-up
TTS – Technology Transfer Strategy TTPP – Technology Transfer Project Plan PIR – Product Introduction Report PDIR – Pharmaceutical Development Interim Report PTR – Product Transfer Report *Validation may occur prior to regulatory submission
ChamQuest
6
1. 分析方法在药品开发 过程中的应用
上海浦融生物科技有限公司 ChamQuest
7
药品开发过程概要
▪ 药物发现(drug discovery/lead optimization)
▪ 早期开发(early development) – 毒理Toxicology – 药代动力学Pharmcokinetics – 临床试验申请IND
MDDS – Microbiological Development Documentation Set
5
上海浦融
ChamQuest
分析方法的生命周期(Life Cycle)
方法的建立
方法的验证
方法的转移
上海浦融
▪ 产品的安全性
Product safety
▪ 制剂的生物利用性
– Dosage form’s bioavailability
▪ 原料,中间体及产品规格的确定
– Spec setting for API, intermediates, and product
▪ 产品的有效期的确定
– Shelf-life of product
Knowledge Management
Quality Risk Management
4
上海浦融
ChamQuest
强生技术转移模式
Phase I
Phase I百度文库A Clinical Trials
Phase IIb
Early Development
Starting Point - (Sourcing Decision)
AMTR (In-Process Testing) – Analytical Method Transfer Report for in-process testing transfer AMTR – Analytical Method Transfer Report
ADDS - Analytical Development Documentation Set
– 输送技术开发 Delivery Development – 技术转移 Technology Transfer ▪ 申报与审批 (Regulatory filings)
上海浦融
ChamQuest
▪ 生产及商业运作 (Manufactu8ring & commercialization)
药品开发中分析测试的作用
Process Performance & Product Quality Monitoring System Corrective Action/Preventative Action (CAPA) System Change Management System Management Review
AMTR
ADDS
Micro Method Transfer
MMTR
MDDS
Development Reports
PTR
Transfer Signoff Acceptance
Timeline for Activity
Ongoing Activity (as required)
Report Name Abbreviations
▪ 制剂配方的优化
– Determining optimum formulation
▪ 杂质与降解物的定性,定量和“确认“
– ID, quantitation and “qualification” of impurities & degradants
Pre-Validation (Final Scale-Up
Activities)
Validation*
Launch
Outputs
TTPP PIR
PDIR
AMTR (In-Process testing)
Analytical Pre-Transfer
Analytical Method Transfer
Phase III Clinical Trials Full Development
File PAI
Filing and Launch Filing and Launch
End Point
Process
Development Activities TTS
Registration Batches (Phase III Clinical Trials)
分析方法的建立与验证
上海浦融生物科技有限公司 ChamQuest
1
分析方法的建立与验证
▪ 0. 引言 ▪ 1. 分析方法在药品开发中的应用 ▪ 2. 分析方法开发的基本问题 ▪ 3. 分析方法的验证与转移
上海浦融
ChamQuest
2
0. 引言
上海浦融生物科技有限公司 ChamQuest
3
药物质量体系
Pharmaceutical Development
Technology Transfer
Investigational Products
Commercial Manufacturing
Product Discontinuation
GMP
PQS elements
Enablers
Management Responsibility
▪ 临床研究 (Clinical) – I&II期临床试验 Clinical phase I&II – III期临床试验 Clinical phase III
▪ 化学与生产控制 (CMC)
– 化学开发 Chemical development – 药品开发 Pharmaceutical development – 分析开发 Analytical development – 工艺放大 Scale-up
TTS – Technology Transfer Strategy TTPP – Technology Transfer Project Plan PIR – Product Introduction Report PDIR – Pharmaceutical Development Interim Report PTR – Product Transfer Report *Validation may occur prior to regulatory submission
ChamQuest
6
1. 分析方法在药品开发 过程中的应用
上海浦融生物科技有限公司 ChamQuest
7
药品开发过程概要
▪ 药物发现(drug discovery/lead optimization)
▪ 早期开发(early development) – 毒理Toxicology – 药代动力学Pharmcokinetics – 临床试验申请IND