Drug Stability Testing: Destroying Drugs for the Purpose of Bringing Them t...
Date and time
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Description
Drug Stability Testing: Destroying Drugs for the Purpose of Bringing Them to Market
Presented by: Steven Baertschi, Ph. D., Baertschi Consulting LLC
Thursday, March 15, 2018 at 6:00 PM
Waters Corporation District Office, 18271 McDurmott E, Suite D, Irvine, CA 92614
Agenda:
- 6:00-6:30 PM Check-In and Networking
- 6:30-7:15 PM Dinner
- 7:15-8:30 PM Presentation and Discussion
Registration: Please register by March 12, 2018 using link below:
Attendance is by pre-registration only – no walk-ins please.
Registration fee includes dinner and presentation.
- Working Professional (includes consultants) - $40
- Working Professional/AAPS member - $35
- Student (full-time)/ Retired/ Unemployed (no consultants) - $15
Abstract:
The process of discovering and developing a new drug is complex, time-consuming, and expensive. One small part of delivering a safe and efficacious drug to the market is understanding the stability characteristics of both the unformulated and formulated compound. Stress testing (aka forced degradation) studies are fundamental to developing this understanding and can be used to predict both the stability and the potential degradation products / pathways of a drug. In this presentation, the foundational aspects of well-designed stress testing studies, the role in stability-indicating method development, in understanding degradation mechanisms, and in solving mass balance issues will be discussed in the context of real-world examples.
Biography:
Dr. Steven Baertschi is President of Baertschi Consulting, a firm specializing in solutions to the most difficult stability, impurity, solid state, analytical, and formulation issues. Retiring from Lilly in 2015, he brings 28+ years of experience in the pharmaceutical industry to his consulting firm, with a demonstrated track record of innovation and problem-solving. He obtained his PhD in Organic Chemistry in 1989 from Vanderbilt University joining Lilly that same year. Dr. Baertschi has organized / Chaired numerous scientific conferences / symposia on stress testing, stability, photostability, and impurities, and has published extensively in these areas, including two editions of a book on pharmaceutical stress testing / drug degradation. Dr. Baertschi is a member of the American Chemical Society (1980), the American Association of Pharmaceutical Scientists (AAPS, 1993), and is a Fellow of the AAPS (since 2007).
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