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Leachables and Extractables Workshop Documents
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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) |
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- 附件 2 : DanNorwoodDay1.pdf
- 附件 3 : DanNorwoodDay2.pdf
- 附件 4 : DavidJacobsonKramDay1.pdf
- 附件 5 : DeGrazioDay2.pdf
- 附件 6 : DianePaskietChemSessionDay2.pdf
- 附件 7 : DianePaskietDay2.pdf
- 附件 8 : GordonHansenDay1.pdf
- 附件 9 : GuiragPoochikianDay2.pdf
- 附件 10 : HelenWinkleDay2.pdf
- 附件 11 : JimBlanchardDay1.pdf
- 附件 12 : LeeNagaoDay2.pdf
- 附件 13 : LeeNagaoWrapUpDay1.pdf
- 附件 14 : Polymer_Additives_PQRI_Poster.pdf
- 附件 15 : PQRI_AET_Poster.pdf
- 附件 16 : PQRI_MBT_Poster.pdf
- 附件 17 : PQRI_Peroxide_Elastomer_Extraction_Poster.pdf
- 附件 18 : PQRI_peroxide_workshop_poster.pdf
- 附件 19 : PQRI_Polypropylene_Extraction_Poster.pdf
- 附件 20 : PQRI_Recommendations_Poster.pdf
- 附件 21 : PQRI_Safety_Poster.pdf
- 附件 22 : RobertKroesDay1.pdf
- 附件 23 : Sulfur_Cured_Elastomer_PQRI_Poster.pdf
- 附件 24 : TerryTougasDay1.pdf
- 附件 25 : ThomasFeinbergDay2.pdf
- 附件 26 : TimMcGovernDay2.pdf
- 附件 27 : WolffDay1.ppt
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2015-09-22 21:55
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