ISBN 9780849394669,Managing Biotechnology In Drug Development

Managing Biotechnology In Drug Development

Author:

Chi-Jen Lee

Publisher:

CRC Press

Rs1596 Rs1995 20% OFF

Availability: Out of Stock

(Free Delivery)

We Accept
ISBN 9780849394669
Check delivery information
 
ISBN 9780849394669
Publisher

CRC Press

Publication Year 1996
ISBN-13

ISBN 9780849394669

ISBN-10 084939466X
Binding

Hardback

Number of Pages 192 Pages
Language (English)
Subject

Engineering & Technology

Contents :

Chapter 1 Introduction
Chapter 2 Regulatory Aspects of the Development of Drugs an Biologics
Chapter 3 Strategies and Management
Chapter 4 Research Institutes and the Biotechnology Industry
Chapter 5 Product Development by Research Institutes and the Pharmaceutical Industry
Chapter 6 Future Perspective: Optimism, Despite It All
Appendix
Index
Features :
Presents evaluation methods for biotechnology-derived products, including characterization of expression vectors and rDNA products, physico-chemical characterization of rDNA proteins, and biological tests for identity and potency
Combines data and facts with personal anecdotes for reading ease
Spotlights key targets of inspection and regulatory action, including manufacturing operations, major equipment and facilities, manufacturing records, and quality assurance
Discusses the use of recombinant DNA technology, chemical synthesis, and immunological methods in vaccine development
Includes two extensive appendices highlighting summary basis of approval for important vaccines
Scroll