通知公告
药学青年学者联合会第十八期学术报告通知

报告时间20201023日下午14:00~16:00

报告地点:中国药科大学(江宁校区)新药学院楼 401会议室

报告题目:Pharmacokinetic Considerations for Topically Applied Drugs

报告人Dr. Danyi Quan

主持人:张文丽 副教授,刘建平教授

 

专家介绍

        Dr. Danyi Quan(全丹毅博士)现任江苏集萃新型药物制剂技术研究所所长、美国爱科赛尔制药(Xel Pharmaceuticals)公司的创始人之一兼首席科学执行官、国际控释协会(CRS)提名委员会委员、CRS中国分会副主席20174月,全博士作为江苏省政府和江苏省产业技术研究院的特聘专家,负责筹建江苏新型药物制剂技术研究所。在创建 Xel公司前,她曾担任美国华生制药公司(现 Teva)研发部部长。全博士一直从事新型药物制剂(DDS)的研发,她及其团队在欧美、日本等国家具有丰富的透皮给药制剂研发经验,并掌握了国际领先的研发程序、实验模型及生产工艺中的核心技术和专有技术。

全博士早年毕业于中国药科大学药学系,留校任教5年,1987年作为第一届日本笹川奖学金获得者前往日本星药科大学攻读博士学位。在日本期间,全博士师从世界著名药剂学家永井恒司教授,在高端制剂领域打下了坚实的理论基础。1991年全丹毅博士前往美国加州大学旧金山分校医学院,跟随现代透皮制剂技术之父Howard I. Maibach教授从事博士后研究。全丹毅博士在美国知名制药企业工作超过30年,在新型药物制剂技术开发、产品研发和产业化领域具有丰富经验,对于科技成果转化和新技术的产业化更有独到见解。由她主持研发的透皮给药制剂已有十几种上市品种,专利及专有技术达20余项。

 

报告摘要

A topically applied drug is any medication that is applied to the body’s surface (e.g., skin) in order to achieve a desired local therapeutic effect. Many drug types fall under the umbrella of topical drugs, including lotions, creams, ointments, gels, foams, and patches. This lecture will focus on drugs applied directly to the skin and where a local response is desired.

Topically applied drugs often follow different requirements for pharmacokinetic (PK) assessment than drugs administered orally or intravenously. For topicals, many required studies are delayed until the final formulation is available and the final formulation strength and dosing regimen have been established in safety and efficacy trials. However, early studies for systemic exposure are advised to confirm assay sensitivity, safety cover, optimal dosing regimen and optimal sampling.

PK studies are required for topical drugs, even when systemic exposure is believed to be negligible or nonquantifiable. The nature of topical drugs can make these studies more complex to design and analyze. When designing these trials, consider the properties of the drug components and the anticipated use conditions.

Clinical pharmacology input is essential to optimize product designs, optimize pharmacokinetic profiles, and to help assess potential safety risks based on systemic exposure. A well thought out and timely clinical pharmacology development plan is essential for any new topically applied drug product.

中国药科大学药学院

药学院青年学者联合会

20201016



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