吸入药物非临床安全性评价策略

Strategy for non-clinical safety evaluation of inhaled drugs

吸入给药的安全性风险主要源自药物的全身暴露和呼吸系统局部的高暴露以及持续滞留。虽然吸入制剂属于近年来发展较快的一类特殊剂型,但其安全性评价的关键点和评价标准尚未形成明确的共识,这也在一定程度上制约了吸入制剂的研发。本文对吸入给药时的关键考虑点进行了文献调研和经验总结,旨在促进吸入给药非临床安全性评价的标准化和规范化。

The safety of inhalation administration lies in the systemic exposure to drugs and high exposure of part of the respiratory system and sustained retention.Although inhalation is a special dosage form which has developed rapidly in recent years,there is no agreement on the key points and evaluation standards of safety evaluation,which restricts the research and development of inhalation preparations to a certain extent.This article reviewed and summarized the key considerations of inhalation administration,aiming to promote the standardization and normalization of non-clinical safety evaluation of inhalation administration.