| Description |
1 online resource (209 pages) : illustrations |
| Contents |
Chapter 1 Identification of Vaccine Targets -- chapter 2 Use of Animals for Vaccine Development -- chapter Validation and Standardization of Serologic Methods for Evaluation of Clinical Immune Response to Vaccines -- chapter Considerations in the Production of Vaccines for Use in Phase 1 Clinical Trials and Preparation of the Manufacturer's Protocol -- chapter 5 Helpful Hints for Preparing an IND Application -- chapter IND Submissions for Vaccines: Perspectives of IND Reviewers -- chapter Technology Transfer: What You Always Wanted to Know But Were Afraid to Ask -- chapter Appendix A Technology Transfer Terminology -- chapter Appendix B Material Transfer Agreement -- chapter Materials Receipt Agreement -- chapter Appendix C -- chapter Appendix D Small-Business Innovation Research (SBIR) Program -- chapter Appendix E Small Business Technology Transfer Research (STTR) Program -- chapter Development of a Transmission-Blocking Vaccine: Malaria, Mosquitoes, and Medicine -- chapter The Victories and Vexations of Vaccine Production-- The Varicella Vaccine -- chapter Acronyms and Abbreviations |
| Summary |
Designed with academic vaccine researchers in mind, this book presents a road map of 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. The result of the editors' own efforts to glean practical information on the steps necessary to manufacture, bottle, and test their vaccines for clinical trials, this book provides answers to researcher questions such as:How do I identify antigens that would produce effective vaccines?Can I produce a clinical lot of vaccine in my laboratory?How should a vaccine be bottled?Which FDA expectations must I meet?What is an IND application and how do I file it?Which CFRs apply to production of a vaccine? |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Lawrence C. Paoletti, Pamela M. McInnes |
| Subject |
Vaccines.
|
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Vaccines -- Testing
|
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Vaccines, Synthetic
|
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Research Design
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Clinical Trials
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Vaccines
|
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MEDICAL / Pharmacology
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Vaccines
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Vaccines -- Testing
|
| Form |
Electronic book
|
| Author |
Paoletti, Lawrence C.
|
|
McInnes, Pamela M.
|
| ISBN |
9781420048902 |
|
1420048902 |
|
9780367802042 |
|
036780204X |
|
