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Vaccine Pre-clinical Toxicology Testing

Vaccine Designs/Concepts

Correlates of Immunity

Assay Development

Animal Models

Immunologic Adjuvants

Variation

International Studies

Behavior

Ethics

Vaccine Design and Methodologic Issues

Assay Validation

Vaccine Pre-clinical Toxicology Testing

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Flowchart 1: Product Development of a Vaccine Candidate

Flowchart 1: Product Development of a Vaccine Candidate Vaccine background, rationale, and justification for dose selection Manufacture GMP Pre-Clinical Toxicity Pre-IND Pre-IND manufacturing lot release Pre-clinical toxicology protocol(s) ICFs Pre-clinical toxicology GLP Prepare Investigators' Brochure Manufacture, control, and fill pre-clinical/clinical lot Certificate of Analysis pharmacology toxicology CMC IND pre-IND meeting request Vaccine background, rationale, and justification for dose selection Manufacture of Vaccine in GMP facility (GMP process development) Pre-Clinical Toxicity testing (protocol development) Phase 1 Clinical protocol (protocol development) Written pre-IND meeting request Pre-IND document CBER pre-IND meeting & recommendations Establish manufacturing process, lot release criteria, stability, uniformity Finalize pre-clinical toxicology protocol(s) Finalize Phase 1 clinical protocol(s), ICFs Pre-clinical toxicology testing in animals under GLP Prepare Investigators' Brochure Manufacture, control, and fill pre-clinical/clinical lot Final report(s) Certificate of Analysis, product characterization Prepare integrated pharmacology/toxicology section Prepare CMC document IND submission CBER review and comment, go/hold decision Phase 1 Clinical Trials


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Last updated January 23, 2003 (cs)