Vaccines

  1. Vaccine Development and Regulation
    1. Preclinical Development
      1. Target Identification
        1. Pathogen Analysis
          1. Antigen Selection
            1. Immunogen Design
            2. Laboratory Studies
              1. In vitro Testing
                1. Proof of Concept Studies
                  1. Formulation Development
                  2. Animal Studies
                    1. Animal Model Selection
                      1. Safety Assessment
                        1. Acute Toxicity
                          1. Repeat Dose Toxicity
                            1. Reproductive Toxicity
                            2. Immunogenicity Testing
                              1. Antibody Responses
                                1. Cellular Responses
                                  1. Dose-Response Studies
                                  2. Efficacy Testing
                                    1. Challenge Studies
                                      1. Protection Correlates
                                  3. Clinical Development
                                    1. Phase I Trials
                                      1. First-in-Human Studies
                                        1. Dose Escalation
                                          1. Safety Monitoring
                                            1. Immunogenicity Assessment
                                              1. Participant Selection
                                              2. Phase II Trials
                                                1. Expanded Safety Assessment
                                                  1. Dose Optimization
                                                    1. Schedule Optimization
                                                      1. Immunogenicity Evaluation
                                                        1. Target Population Studies
                                                        2. Phase III Trials
                                                          1. Large-scale Efficacy Studies
                                                            1. Randomized Controlled Design
                                                              1. Statistical Considerations
                                                                1. Sample Size Calculation
                                                                  1. Primary Endpoints
                                                                    1. Secondary Endpoints
                                                                    2. Safety Monitoring
                                                                      1. Data Safety Monitoring Board
                                                                        1. Interim Analyses
                                                                        2. Regulatory Interactions
                                                                        3. Phase IV Studies
                                                                          1. Post-marketing Surveillance
                                                                            1. Real-world Effectiveness
                                                                              1. Long-term Safety
                                                                                1. Special Population Studies
                                                                              2. Regulatory Approval Process
                                                                                1. Regulatory Authorities
                                                                                  1. FDA in United States
                                                                                    1. EMA in Europe
                                                                                      1. WHO Prequalification
                                                                                        1. National Regulatory Agencies
                                                                                        2. Approval Pathways
                                                                                          1. Standard Approval Process
                                                                                            1. Accelerated Approval
                                                                                              1. Emergency Use Authorization
                                                                                                1. Conditional Marketing Authorization
                                                                                                2. Regulatory Requirements
                                                                                                  1. Chemistry, Manufacturing, and Controls
                                                                                                    1. Nonclinical Studies
                                                                                                      1. Clinical Studies
                                                                                                        1. Risk Management Plans
                                                                                                        2. Post-approval Obligations
                                                                                                          1. Periodic Safety Updates
                                                                                                            1. Risk Evaluation and Mitigation Strategies
                                                                                                              1. Post-marketing Studies
                                                                                                            2. Manufacturing and Quality Control
                                                                                                              1. Good Manufacturing Practices
                                                                                                                1. Facility Requirements
                                                                                                                  1. Personnel Qualifications
                                                                                                                    1. Documentation Systems
                                                                                                                    2. Production Processes
                                                                                                                      1. Cell Culture Systems
                                                                                                                        1. Primary Cells
                                                                                                                          1. Continuous Cell Lines
                                                                                                                            1. Viral Production
                                                                                                                            2. Fermentation Processes
                                                                                                                              1. Bacterial Production
                                                                                                                                1. Yeast Production
                                                                                                                                  1. Scale-up Considerations
                                                                                                                                  2. Purification Methods
                                                                                                                                    1. Chromatography
                                                                                                                                      1. Filtration
                                                                                                                                        1. Concentration
                                                                                                                                      2. Formulation Components
                                                                                                                                        1. Active Ingredients
                                                                                                                                          1. Adjuvants
                                                                                                                                            1. Aluminum Salts
                                                                                                                                              1. Oil-in-Water Emulsions
                                                                                                                                                1. Novel Adjuvants
                                                                                                                                                2. Stabilizers
                                                                                                                                                  1. Sugars
                                                                                                                                                    1. Amino Acids
                                                                                                                                                      1. Proteins
                                                                                                                                                      2. Preservatives
                                                                                                                                                        1. Thimerosal
                                                                                                                                                          1. Phenol
                                                                                                                                                            1. Benzyl Alcohol
                                                                                                                                                          2. Quality Control Testing
                                                                                                                                                            1. Identity Testing
                                                                                                                                                              1. Purity Testing
                                                                                                                                                                1. Potency Testing
                                                                                                                                                                  1. Safety Testing
                                                                                                                                                                    1. Sterility
                                                                                                                                                                      1. Endotoxin
                                                                                                                                                                        1. Residual DNA
                                                                                                                                                                      2. Fill and Finish Operations
                                                                                                                                                                        1. Aseptic Processing
                                                                                                                                                                          1. Container Closure Systems
                                                                                                                                                                            1. Labeling Requirements
                                                                                                                                                                            2. Batch Release Testing
                                                                                                                                                                              1. Lot Release Criteria
                                                                                                                                                                                1. Certificate of Analysis
                                                                                                                                                                                  1. Regulatory Oversight

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                                                                                                                                                                              2. Types of Vaccines

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                                                                                                                                                                              4. Vaccine Administration and Immunization Programs