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)