The Problems of the Safety Evaluation of Biotechnology Derived Drugs

被引:0
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作者
L.CAPRINO
G.TOGNA
机构
[1] Institute
[2] Institute of Medical pharmacology IV Chair of Pharmacology University of Rome "La Sapienza"
[3] P.le A.Moro 5
[4] 00185 Rome
[5] Italy
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The Problems of the Safety Evaluation of Biotechnology Derived Drugs;
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摘要
Recent years have witnessed rapid advances in the toxicologic assessment of biotechproducts.Safety assessment of a biotech product is a complex and multiple process.This includes a knowledge of its pharmaco-biological characteristics,and identifyingthe target patient population and the proposed clinical application. To make a decision on the safe human application(the products are administering tohumans for therapeutic purposes),besides the identity and purity of the final product,
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页码:413 / 418
页数:6
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