Biotechnology And Safety Assessment
John A. Thomas
CRC Press, Jun 30, 1993 - Medical - 350 pages
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.
What people are saying - Write a review
We haven't found any reviews in the usual places.
Their Development Safety and Efficacy
Safety Assessment of Biotechnology Products
ToxicologyEvaluation of BiotechnologyDerived Products
Clinical Pharmacology of rDNA Agents
Drug Delivery Systems and Recombinant Proteins
In VitroIn Vivo Toxicology
Biotransformation of Xenobiotics
Other editions - View all
absorption acid activity administration animal models antigen assay biochemical biotechnology biotransformation blood bone marrow cancer cell lines cellular chemical chromosome clinical trials cloned colony-stimulating factor compounds conjugation CSFs culture cytochrome cytokines cytotoxicity Diabetes Diabetes mellitus disease dosage dose effects efficacy endpoints enzyme erythropoietin evaluation exposure function gene therapy gene transfer genetically engineered GM-CSF Goldberg Hepatitis hybridoma immune immunologic infection inhibition insect-resistant cotton insertion insulin Interferon interleukin-2 irritation liposomes lymphocytes Mary Ann Liebert mechanism metabolism methods mice microorganisms molecular molecules monkey monoclonal antibodies mouse mutation novel foods oligonucleotides organ oxidation patients peptides pharmaceutical pharmacodynamic pharmacokinetic Pharmacol pharmacologic phase plants polymers potential preclinical protein recombinant human regulatory response result retroviral safety assessment sequence specific studies substrate syndrome TABLE target techniques test systems therapeutic tion tissue toxicity Toxicol toxicology transgenic animals tumor Unspecified vector viral virus vitro vitro toxicology vivo xenobiotic yes yes yes