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Vaccine Pre-clinical Toxicology Testing

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Vaccine Pre-clinical Toxicology Testing

Previous - Pre-clinical Safety Testing of Candidate Vaccines | Next - Pre-IND and IND Submissions

Flowchart 3: Pre-clinical Safety Testing

Flowchart 3: Pre-clinical Safety Testing Local & Systemic Toxicology Repeated dose: over dose range, mimicking proposed clinical protocol GLP GLP Protocol including endpoints Raw Data GLP GLP Report(s) Specialized Pre-clinical toxicology and safety testing Genetic Toxicity Other product-specific safety Assay parameter optimization Plan to apply sensitive method to detect vaccine in tissues Primer design, Assay parameter optimization Biodistribution GLP GLP Protocol including endpoints Raw Data Vaccine integration into genome in tissues where there is persistent distribution No persistence found Evaluate positive tissues from biodistribution study Separate target from genomic DNA to confirm or disprove integration GLP GLP Report(s) Raw Data Pharmacology toxicology Prepare integrated pharmacology/toxicology section Reproductive Toxicology Tumorigenicity IND IND Submission


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Last updated January 23, 2003 (cs)