报批美国FDA仿制药研发与相关问题探讨-Final.ppt

开发报批美国FDA的仿制药与相关问题探讨
上海复星普适医药科技有限公司
何平
内容提要
开发仿制药的重要性和机遇
开发仿制药的挑战
申报仿制药的分类
仿制药研发团队
仿制药的研发过程
QbD在制剂开发中怎么体现
研发(高难)仿制药的一些体会:案例研究
开发仿制药的重要性
新药与仿制药-NDA and ANDA
开发仿制药与我国药物研发的海外战略
药物制剂
目标主流市场
开发仿制药的挑战性
开发仿制药更具挑战性
药物制剂
专利
仿制药的竞争
仿制药厂之间的竞争
由品牌药转成仿制药
仿制药竞争的方式HOW PETE
Cost-IR Product
Raw Materials
Process
Finished Product
Technology-Modified Release Products
申报(仿制)新药的分类
规范市场(FDA)
1。P-I
2。P-II
3。P-III
4。P-IV (1st to file)
中国市场(sFDA)
1类
2类
3类
4类
5类
6类
仿制药研发团队CONCEPT-1 BUILD UP A TEAM
INFORMATION
FORMULATION
PRODUCT
REGULATORY
ANALYTICAL
BIO-PHARMACEUTICAL
PROJECT
LEGEL
DRUG DELIVERY SYSTEMS FOR ORAL SOLID FORMULATIONS-MR
MATRIX SYSTEMS
RESERVIOR SYSTEMS
OSMOTICAL PUMP BO-SYSTEMS
缓控释给药的技术平台和给药系统CONCEPT-2 BUILD UP A SYSTEM
Product Development Roadmap
仿制药的研发过程
• Quality
– Acceptably low risk of failing to achieve the desired clinical attributes
• Pharmaceutical Quality
= f {drug substance, excipients, manufacturing..}
• QbD
–‘Product and process performance characteristics
scientifically designed to meet specific objectives, not merely empirically derived from performance of test batches’
What is QbD (Quality by Design )?
QbD在制剂开发中怎么体现?