Buch, Englisch, 224 Seiten, Format (B × H): 185 mm x 262 mm, Gewicht: 612 g
From Concept to Clinic: A Guide to the Development and Clinical Testing of Vaccines for Human Use
Buch, Englisch, 224 Seiten, Format (B × H): 185 mm x 262 mm, Gewicht: 612 g
ISBN: 978-0-8493-1168-0
Verlag: Taylor & Francis Inc
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?
Zielgruppe
Academic and Professional Practice & Development
Autoren/Hrsg.
Fachgebiete
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Labormedizin
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Medizinische Mikrobiologie & Virologie
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Klinische und Innere Medizin Allergologie
Weitere Infos & Material
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.
