Biotechnology And Safety AssessmentJohn A. Thomas 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. |
Contents
Their Development Safety and Efficacy | 1 |
Safety Assessment of Biotechnology Products 23 | 23 |
ToxicologyEvaluation of BiotechnologyDerived Products | 37 |
Clinical Pharmacology of rDNA Agents 59 | 67 |
Drug Delivery Systems and Recombinant Proteins 72 | 79 |
In VitroIn Vivo Toxicology | 97 |
Biotransformation of Xenobiotics | 131 |
Other editions - View all
Common terms and phrases
absorption acid activity administration animal models antigen assay biotechnology biotransformation blood bone marrow cancer cell lines cellular chemical chromosome clinical trials cloned colony-stimulating factor compounds conjugation culture cytokines cytotoxicity Diabetes Diabetes mellitus disease dosage dose effects efficacy endpoints enzyme erythropoietin evaluation exposure function gene therapy gene transfer genetically engineered glutathione GM-CSF Goldberg Hepatitis hormone hybridoma immune immunologic infection inhibition insect-resistant cotton insertion insulin Interferon Interleukin-2 irritation Kuru disease liposomes lymphocytes Mary Ann Liebert mechanism metabolism methods mice microorganisms molecular molecules monkey monoclonal antibodies mouse mutation novel foods oligonucleotides organ oxidation patients peptides Pharm pharmaceutical pharmacodynamic pharmacokinetic Pharmacol pharmacologic phase plants polymers potential preclinical 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