Biotechnology And Safety Assessment

Front Cover
John A. Thomas
CRC Press, Jun 30, 1993 - Medical - 350 pages
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In this volume, experts from academe, industry, and public health institutes discuss the issues involved in toxicology evaluation, safety assessment, and regulation of biotechnology-derived drugs, foods, and plant products. Coverage includes recombinant DNA agents, monoclonal antibodies, recombinant hormones and other proteins, biotechnology-derived drug delivery systems, gene therapy for genetic diseases, and genetically engineered plants and plant products. Full consideration is given to key methodological issues in product development and testing, such as use of "in vitro" and "in vivo" toxicology tests, choice of animal models, and use of transgenic animal models and genetically altered species to study human diseases. The book includes an appendix describing available animal models and a glossary of terms, definitions, and acronyms.
 

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Contents

Their Development Safety and Efficacy
1
Safety Assessment of Biotechnology Products
23
ToxicologyEvaluation of BiotechnologyDerived Products
37
Clinical Pharmacology of rDNA Agents
59
Drug Delivery Systems and Recombinant Proteins
79
In VitroIn Vivo Toxicology
97
Biotransformation of Xenobiotics
131
Some Concepts of Gene Therapy and Genetic Diseases
163
Transgenic Animal Models and Genetically Altered Species
179
Safety Evaluation of Genetically Engineered Plants and Plant
199
BiotechnologyDerived
213
Glossary of Terms Definitions and Acronyms
245
Index
261
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