药典

【内容】
建模与模拟已被制药界认同作为为评价生物药剂学性质的有效方法，近几年，关于在药物早期研究及后期开发中应用建模与模拟方法的报道越来越多。
从2004年开始，美国FDA仿制药办公室（OGD）开始应用这些方法支持各种各样的法规监管活动。
本次网络讲座将讲解几个FDA仿制药办公室应用建模与模拟的案例，以便回答仿制药口服给药时生物药剂学性质的问题。
【讲解人】
Xinyuan (Susie) Zhang, Ph.D.
Staff Fellow
FDA审评中心仿制药办公室
Date: 11月18日晚上12点-凌晨1:30

Modeling and simulation have been recognized as valuable tools to assess biopharmaceutical performance. Applications of these tools in drug research and development have been reported increasingly.
Since 2004, the Office of Generic Drugs (OGD) at the US Food and Drug Administration (FDA) has started to apply these tools to support various regulatory activities.
This webinar provides a few examples of modeling and simulation in the OGD for the purpose of addressing biopharmaceutical performance questions for orally administered generic drug products.

Presenter:
Xinyuan (Susie) Zhang, Ph.D.
Staff Fellow
Office of Generic Drugs/CDER/FDA
Date: Wed, Nov 19, 2014 12:00 AM - 1:30 AM CST

会议报名链接：cuturl('http://www.pharmogo.com/technical.php?act=show&id=17')