This popular book delineates how a vaccine develops from an idea in a researcher's imagination, to the lab bench, through preclinical evaluation, and into the clinic for safety and immunogenicity. Based on the results of the editors' own efforts to glean practical information on the steps necessary to manufacture, bottle, and test their vaccines for clinical trials, the book provides answers to numerous questions posed by researchers. The chapters outline basic approaches to vaccine development in its earliest stages, explain how to set up quantitative assessments of antibody responses to…mehr
This popular book delineates how a vaccine develops from an idea in a researcher's imagination, to the lab bench, through preclinical evaluation, and into the clinic for safety and immunogenicity. Based on the results of the editors' own efforts to glean practical information on the steps necessary to manufacture, bottle, and test their vaccines for clinical trials, the book provides answers to numerous questions posed by researchers. The chapters outline basic approaches to vaccine development in its earliest stages, explain how to set up quantitative assessments of antibody responses to vaccines, and give helpful hints on making vaccines in the laboratory.
Identification of Vaccine Targets. Use of Animals for Vaccine Development. Validation and Standardization of Serologic Methods for Evaluation of Clinical Immune Response to Vaccines. Considerations in the Production of Vaccines for Use in Phase 1 Clinical Trials and Preparation of the Manufacturer's Protocol. Helpful Hints for Preparing an IND Application. IND Application Submissions for Vaccines: Perspectives of IND Reviewers. Technology Transfer: What You Always Wanted to Know But Were Afraid to Ask. Development of a Transmission-Blocking Vaccine: Malaria, Mosquitoes, and Medicine. The Victories and Vexations of Vaccine Production -The Varicella Vaccine.
Identification of Vaccine Targets. Use of Animals for Vaccine Development. Validation and Standardization of Serologic Methods for Evaluation of Clinical Immune Response to Vaccines. Considerations in the Production of Vaccines for Use in Phase 1 Clinical Trials and Preparation of the Manufacturer's Protocol. Helpful Hints for Preparing an IND Application. IND Application Submissions for Vaccines: Perspectives of IND Reviewers. Technology Transfer: What You Always Wanted to Know But Were Afraid to Ask. Development of a Transmission-Blocking Vaccine: Malaria, Mosquitoes, and Medicine. The Victories and Vexations of Vaccine Production -The Varicella Vaccine.
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