Perez M K
J Toxicol Environ Health. 1977 Dec;3(5-6):837-57. doi: 10.1080/15287397709529618.
Before a new drug is approved for use in food-producing animals, data are required which demonstrate that food derived from the animal does not contain unsafe residues. Also, an analytical method for residues must be provided which is practicable for government surveillance and enforcement activities. Residue information is derived by using radiolabeled drugs to study metabolism in the animal for which the drug is intended. Residues in the edible tissues are characterized, and the amount of residues and their rates of depletion from the different tissues after cessation of drug treatment are determined. Bioassays with laboratory animals are used to study the toxicity of the drug and its important metabolites and to establish tolerance limitations. From this information, the conditions for the analytical method are established--that is, the compound(s) measured (the marker), the tissue (target tissue) monitored to ensure control of "total residue", and the required sensitivity. The method is subjected to validation in government laboratories and must meet the Food and Drug Administration's standards of precision, accuracy, specificity, and practicability. Finally, the method is used in simulated field trials to establish the required withdrawal time after drug treatment before the animals can be marketed for their milk or for slaughter for food.
在一种新药被批准用于食用动物之前，需要有数据证明来自动物的食品不含有不安全的残留。此外，必须提供一种残留分析方法，该方法对于政府的监测和执法活动是可行的。残留信息是通过使用放射性标记药物来研究药物在目标动物体内的代谢情况而获得的。对可食用组织中的残留进行表征，并确定停药后不同组织中残留的量及其消除速率。用实验动物进行生物测定，以研究药物及其重要代谢物的毒性，并确定耐受限度。根据这些信息，确定分析方法的条件，即测定的化合物（标志物）、监测的组织（目标组织）以确保对“总残留”的控制以及所需的灵敏度。该方法要在政府实验室进行验证，并且必须符合食品药品监督管理局的精密度、准确度、特异性和实用性标准。最后，该方法用于模拟田间试验，以确定药物治疗后动物能够上市销售其牛奶或屠宰以供食用之前所需的停药时间。
