Vaccines, Blood & Biologics
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Risk Mitigation Strategies to Address Potential Procoagulant Activity in Immune Globulin Products Presentations
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Session I
- Session I: Panel Discussion (PDF - 129KB) [ARCHIVED]
- OCTAGAM®, Intravenous Immunoglobulin Associated With Thrombotic Events (PDF - 584KB) [ARCHIVED]
- Factor XIa and Thrombosis (PDF - 1.3MB) [ARCHIVED]
- IGIV and Thromboembolism Handout FDA Meeting 5/17/2011 (PDF - 166KB) [ARCHIVED]
IG- Associated Thrombotic Adverse Events – Pharmacovigilance (PDF - 205KB) [ARCHIVED]Potential Causes of Thrombotic Events in IGIV Treatment (PDF - 1MB) [ARCHIVED]Analysis of Spontaneously Reported Thromboembolic Events (TEE) for Patients Under IVIG Treatment, 2005 – 2010 (PDF - 227KB) [ARCHIVED]Laboratory Investigations of Products Associated with Thrombotic Events (PDF - 445KB) [ARCHIVED]Laboratory Investigations of Intravenous Immunoglobulin (IVIG) Products Associated with Thromboembolic Events (PDF - 397KB) [ARCHIVED]NIBSC Investigation on Thrombogenicity Tests for IVIG (PDF - 860KB) [ARCHIVED]Retrospective Claims Claims-Based Cohort Study of Immune Globulin Administration and Occurrence of TEEs (PDF - 213KB) [ARCHIVED]Retrospective Claims Claims-Based Cohort Study of Immune Globulin Administration and Occurrence of TEEs (Addendum) (PPT - 82KB)Adverse Event Reports to FDA for Immunoglobulins and TEEs (PDF - 131KB) [ARCHIVED]Mechanisms of Thrombosis (PDF - 694KB) [ARCHIVED]
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Session II
Manufacture of Immunoglobulin Therapies Relationship to Thrombogenicity (PDF - 761KB) [ARCHIVED]Minimizing Procoagulant Impurities in IGIV Products Baxter's Approach (PDF - 384KB) [ARCHIVED]Characterization of proteolytical Activity in IgG (PDF - 336KB) [ARCHIVED]Procoagulant Activity Trend Analysis During the Manufacturing of IVIG (PDF - 989KB) [ARCHIVED]Risk Mitigation Strategies to Address Procoagulant Activity in Immune Globulin Product (PDF - 1.1MB) [ARCHIVED]Findings from Two Mathematical Models of Thrombus Formation Under Flow: FXI and FXIa, When Do They Matter? (PDF - 2.1MB) [ARCHIVED]Session II: Manufacturer´s Experience (PDF - 103KB) [ARCHIVED]
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