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急性毒性试验的方法学方面,尤其是半数致死剂量(LD50)的测定,在新药研发中具有应用价值。

Methodological aspects of acute toxicity testing particularly LD50 determinations present use in development of new drugs.

作者信息

Fowler J S, Rutty D A

出版信息

Acta Pharmacol Toxicol (Copenh). 1983;52 Suppl 2:20-30. doi: 10.1111/j.1600-0773.1983.tb02681.x.

Abstract

It is essential to have an adequate understanding of the acute toxic effects of a new drug. It may not be necessary however to blindly follow the full classical median lethal assay on every occasion. The LD50 was developed to obtain the maximum accuracy from a modest experimental size. The objective of the study and the limitations of the assay should not be overlooked however and undue precision should not be sought. Methodological aspects including species and maximum and minimum doses will be discussed. Other methods and approaches to acute toxicity will be recommended with a more broad approach to acute toxicity than lethality alone.

摘要

充分了解新药的急性毒性作用至关重要。然而,并非每次都有必要盲目遵循完整的经典半数致死量测定法。半数致死量(LD50)的提出是为了在适度的实验规模下获得最大的准确性。然而,不应忽视研究目的和该测定法的局限性,也不应追求过高的精确度。将讨论包括物种、最大和最小剂量在内的方法学方面。将推荐其他急性毒性的方法和途径,采用比单纯致死性更广泛的急性毒性研究方法。

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