Vaccines, from Concept to Clinic A Guide to the Development and Clinical Testing of Vaccines for Human Use

Lawrence C. Paoletti, Pamela M. McInnes

Hardback (29 Jul 1998)

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Publisher's Synopsis

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?

Book information

ISBN:	9780849311680
Publisher:	CRC Press
Imprint:	CRC Press
Pub date:	29 Jul 1998
DEWEY:	615.372
DEWEY edition:	21
Language:	English
Number of pages:	209
Weight:	613g
Height:	254mm
Width:	178mm
Spine width:	14mm