Vaccines
From Concept to Clinic: A Guide to the Development and Clinical Testing of Vaccines for Human Use
Seiten
1998
Crc Press Inc (Verlag)
978-0-8493-1168-0 (ISBN)
Crc Press Inc (Verlag)
978-0-8493-1168-0 (ISBN)
This text examines 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. It provides information on the steps necessary to manufacture, bottle and test vaccines for clinical trials.
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?
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?
Lawrence C. Paoletti, Pamela M. McInnes
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.
| Erscheint lt. Verlag | 29.7.1998 |
|---|---|
| Zusatzinfo | 23 Tables, black and white |
| Verlagsort | Bosa Roca |
| Sprache | englisch |
| Maße | 178 x 254 mm |
| Gewicht | 589 g |
| Einbandart | gebunden |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Dermatologie |
| Medizin / Pharmazie ► Medizinische Fachgebiete ► Laboratoriumsmedizin | |
| Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie | |
| Studium ► Querschnittsbereiche ► Infektiologie / Immunologie | |
| Naturwissenschaften ► Biologie | |
| Technik | |
| ISBN-10 | 0-8493-1168-3 / 0849311683 |
| ISBN-13 | 978-0-8493-1168-0 / 9780849311680 |
| Zustand | Neuware |
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