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吸入和鼻腔给药的毒理学研究

Toxicology Studies for Inhaled and Nasal Delivery.

作者信息

Wolff R K

机构信息

RK Wolff - Safety Consulting Inc, Fort Myers, Florida 33907, United States.

出版信息

Mol Pharm. 2015 Aug 3;12(8):2688-96. doi: 10.1021/acs.molpharmaceut.5b00146. Epub 2015 May 13.

Abstract

This review examines issues related to the toxicological testing of pharmaceuticals delivered by the inhalation or nasal route. The purpose of the toxicology studies is to conduct studies in animals that will aid the assessment of the safety of these agents delivered to patients. Inhalation toxicology studies present some unique issues because the dosing method differs from more standard administration methods such as oral or injection administration. Also, dose determination issues are more complex, particularly for inhalation administration since it is often difficult to determine the amount of material delivered to the lung both for patients and in animal toxicology studies.

摘要

本综述探讨了与通过吸入或鼻腔途径给药的药物毒理学测试相关的问题。毒理学研究的目的是在动物身上进行研究,以帮助评估这些给患者使用的药物的安全性。吸入毒理学研究存在一些独特的问题,因为给药方法不同于口服或注射给药等更标准的给药方式。此外,剂量确定问题更为复杂,尤其是对于吸入给药而言,因为在患者和动物毒理学研究中,往往难以确定输送到肺部的药物量。

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