Weber N E
Toxicol Eur Res. 1982 Sep;4(5):271-5.
Due to the use of radiolabeled drugs and feed additives in residue evaluation of preclearance approval of new animal drug applications (NADAs), metabolites including those which are covalently bound are detected in the edible tissues of target food animals. Isolation and characterization of these residues is often a difficult task. The approach taken is to couple safety assessment with development of the required residue information. An outline of data development is made in the context of toxicity assessment. Unless otherwise adjusted, the sponsor's method of residue analysis and drug withdrawal time reflect responsibility of all drug residues of toxicological concern found in edible tissues. The use of bioavailability studies and how they interact with safety evaluation is developed. Focus is brought to the specific problem of covalently bound residues and a framework for their assessment is presented.
由于在新动物药品申请（NADA）清除前批准的残留评估中使用了放射性标记药物和饲料添加剂，在目标食用动物的可食用组织中检测到了包括共价结合代谢物在内的代谢物。分离和鉴定这些残留通常是一项艰巨的任务。所采用的方法是将安全性评估与所需残留信息的开发相结合。在毒性评估的背景下制定了数据开发大纲。除非另有调整，申办者的残留分析方法和停药时间反映了在可食用组织中发现的所有具有毒理学关注的药物残留的责任。阐述了生物利用度研究的应用以及它们与安全性评估的相互作用。重点关注共价结合残留的具体问题，并提出了评估框架。
