Vaccines From Concept to Clinic
A Guide to the Development and Clinical Testing of
Vaccines for Human Use
Pages: 224

Harvard Medical School, Boston, MA. Describes how a vaccine is taken from an idea in a researcher's imagination to the lab bench through preclinical evaluation, into the clinic for safety immuno- genicity and efficacy, and ultimately to commercialization as a licensed product. For clinicians and researchers. DNLM: Vaccines, Synthetic.
TOC:
Chapter 1 Identification of Vaccine Targets
Chapter 2 Use of Animals for Vaccine Development
Chapter 3 Validation and Standardization of Serologic Methods for Evaluation of Clinical Immune Response to Vaccines
Chapter 4 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 6 IND Application Submissions for Vaccines: Perspectives of IND Reviewers
Chapter 7 Technology Transfer: What You Always Wanted to Know But Were Afraid to Ask
Chapter 8 Development of a Transmission-Blocking vaccine: Malaria, Mosquitoes, and Medicine
Chapter 9 The Victories and Vexations of Vaccine Production--The Varicella Vaccine
Acronyms and Abbreviations
Index
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