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Safety Evaluation of Biotechnology Derived Products
Some Aspects of the Preclinical Safety of Drugs Produced By Recombinant
Government Regulatory Position in the Federal Republic of Germany
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activity administration agents animal model antibody formation antigen approach appropriate approval assessment biological biotechnical products biotechnology products case-by-case cell chemical chimpanzees clinical trials compounds contaminants cynomolgus monkeys detect discussion Editors Vol effects endogenous evaluation of biotechnology experience experimental Galbraith GM-CSF growth hormone guidelines helper T cells Hendrickx high dose human proteins immune response immunogenicity increased insulin Intended For Human interferon interleukin-2 intravenous Japanese laboratory lymphokines macaque manufacturing material Mexico State University monoclonal antibodies neutralizing antibodies nonhuman primates normal observed organs patients peptides pharmaceutical pharmacokinetic pharmacological physiological potential preclinical evaluation preclinical safety Primate Research Institute procedures proteins rats recombinant DNA technology regulatory agencies regulatory positions relevant reproductive rhesus monkeys rodents safety evaluation safety studies safety testing scientific similar species selection Stoll substance Table teratogenic Teratology therapeutic toxicity studies toxicity testing toxicological toxicological testing ug/kg variation vitro vivo weeks xenobiotics yg/kg Zbinden