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Pfizer to Demo Web-Based Degradation Profile Database
Efforts to benchmark forced degradation best practices continue at the 2nd Annual Forced Degradation Studies event on Feb 15-17 2005, in Washington DC. The 2005 program examines different stress testing conditions and techniques in greater depth through industry case studies. Particular attention will be paid to oxidative and photo stress testing. HIGHLIGHTS OF THE 2ND ANNUAL FORCED DEGRADATION STUDIES INCLUDE: -- Live Demo of A Structure Searchable Web-Based Degradation Profile Database for the Pharmaceutical Industry: Pfizer -- Ex-FDA representative on the Regulator's Perspective on Pharmaceutical Stress Testing -- Case Study on Completing a Forced Degradation Package for an NDA Filing: Pfizer -- Early Prediction of Pharmaceutical Oxidation Pathways by Computational Chemistry & Forced Degradation: Pfizer -- Photosensitized Singlet Oxygen-Mediated Degradation of an Angiotensin II Antagonist, Losartan Potassium: Merck
-- Using Forced Photostability Degradation Study Data to Drive Decision-Making During Pharmaceutical Development: Merck -- Mass Balance: Radiolabeled API to Determine Primary Degradation Products & Analytical Flaws: Purdue Pharma -- Developing an Automated Process for Forced Degradation Studies in Early Development: Johnson & Johnson -- Development of a Screening Model for Assessing Chemical Stability of Corticosteroids in Metered-Dose-Inhaler Formulations: 3M Pharmaceuticals -- Degradation Chemistry at Pre-Candidate Selection: Predictions, Studies, & Structural Elucidation: GlaxoSmithKline There is also a pre-conference seminar on Tues, Feb 15 2005, An Introduction to Stress Testing for Small Molecule Pharmaceuticals. THE COMPLETE AGENDA IS AVAILABLE FOR DOWNLOADING AT: http://mailiwant.com/links.jsp?linkid=17495&subid=2387848&campid=139309&type=0 TO REGISTER ONLINE: http://mailiwant.com/links.jsp?linkid=17496&subid=2387848&campid=139309&type=0 This is the only forum that fully addresses the complex issue of forced degradation studies for small molecule pharmaceuticals. Please register early, as we expect the conference to sell out. To register call 888-670-8200 US or 941-951-7885 Intl; 941-365-2507 fax; register@iirusa.com