正文
12:00-13:00
午餐
13:00-14:00
药物研发早期制剂开发（临床前至一期）
摘要：
The decisions made during early stages of pharmaceutical product development have implications that reaches far into the later stages of development. Often times these decisions set the tone for the overall development program, and directly affects the complexity, cost, and overall timeline. Ideally, early stage product development activities should be undertaken with the commercial product characteristics in mind. When combining this information with preclinical and preformulation data, the appropriate product can be defined, and subsequently the best manufacturing process selected. For example, if the desired final dosage form is a tablet, an important decision to make during early product development is whether conventional manufacturing processes such as direct compression or wet granulation will be adequate, or if an enabled approach is needed, especially for compounds with low aqueous solubility. These aspects and considerations of early stage development will be discussed in the talk and illustrated through case studies presented.
Alfred Rumondor,默沙东，美国
14:00-15:15
药物研发后期口服制剂开发（二期，三期，放大，生产）
Umesh Kestur, 百世美施贵宝，美国
15:15-15:30
茶歇
15:30-16:30
膜给药系统
Film technology general overview
Prefabricated film technology introduction and application with case studies
Rodolfo Pinal, 普渡大学，美国
16:30-18:00
与临床相关的质量标准设定及实例
The presentation will focus on various approaches to establish Clinically Relevant Dissolution Specifications for Immediate Release solid oral dosage forms
Key in-put, information needed, and challenges
A roadmap for the development of Clinically Relevant Specifications
Examples for In-Vivo In-Vitro Relationships/Correlations
Application of Clinically Relevant Dissolution specifications throughout product life-cycle management
溶出方法开发历程（一期至三期）
摘要：
•
The presentation will discuss the strategy of dissolution method development for conventional and enabled drug product, including solubility consideration, dissolution mechanism, and method sensitivity
•
Regulatory dissolution and biorelevant dissolution
Case study of predictive dissolution to inform formulation selection.
Andreas Abend,默沙东，美国
