Posters

• Introduction To Polymer Additives And Stabilization
• The Analytical Evaluation Threshold
• Analysis of Mercaptobenzothiazole (MBT) Compounds from Sulfur Cured Rubber by a Liquid Chromatography
• Case Study: Method Optimization and Extractables Characterization of a Peroxide Cured Rubber
• Controlled Extraction Study "Unknown" Elastomer
• Controlled Extraction Study On Polypropylene Test Article
• Summary of the PQRI Leachables and Extractables Recommendations
• Safety Qualification Thresholds for Leachables in OINDP
• Validation Of Extractables And Leachables Method For A Sulfur-Cured Elastomer

Presentations

• Day 1
• Workshop on Leachables and Extractables (Terry Tougas)
• Challenges in Orally Inhaled and Nasal Drug Products (Gordon Hansen)
• Leachables and Extractables in OINDP: An FDA Perspective (Alan Schroeder)
• Threshold Of Toxicological Threshold Of Toxicological Concern (TTC) In Risk Assessment (Robert Kroes)
• Derivation and Justification of Safety Thresholds (Doug Ball)
• Best Practices for Leachables and Extractables Testing (Daniel Norwood)
• Specifics of Safety Recommendations (David Jacobson Kram)
• Development and Justification of a Safety Concern Threshold (Mark Vogel)
• Development and Justification of Qualification Threshold (Ron Wolf)
• Safety Qualification Process and Application of Thresholds (James Blanchard)
• Wrap Up of Day 1, Looking Forward to Day 2 (Lee Nagao)
• Day 2
• Opening Remarks – Day 2 (Diane Paskiet)
• Container Closure System Components Composition and Selection (Fran DeGrazio)
• Controlled Extraction Studies (Tom Feinberg)
• Leachable Studies and Routine Extractables Testing (Diane Paskiet)
• Development and Application of the Analytical Evaluation Threshold (Daniel Norwood)
• Summary of Discussions (Lee Nagao)
• Safety Recommendations: Science and Process (Tim McGovern)
• Best Practices Recommendation: Regulatory Science Strategies (Guirag Poochikian)
• Direction for Leachables/Extractables (Helen Winkle)