Drudge J H, Lyons E T
Am J Vet Res. 1977 Oct;38(10):1581-6.
The critical test is the primary method used for the efficacy evaluation of drugs against the major internal parasites (bots, ascarids, large strongyles, small strongyles, and pinworms) of the horse. The critical test determines: (1) spectrum of activity, (2) effectiveness of removal, (3) pattern of discharge, and (4) physical condition of each species of these parasites. General characteristics of the major parasitisms of the horse are discussed briefly. Criteria of the critical test also are considered including: (1) number of tests, (2) strain variation and drug resistance, (3) selection of test horses, (4) diagnosis of parasitic species, (5) numbers of parasites, (6) minimal efficacy requirements, and (7) other parasitic species. The controlled test principally is used on a selected basis for the small nematodes in the proximal portion of the digestive tract which cannot be properly evaluated by the critical test, or for other limited objectives. Clinical trials are discussed briefly but are invaluable supplements to the critical and controlled tests in the total assessment of a drug as a new product or for continued effectiveness in clinical use. Experimental procedures used in the conduct of drug evaluations should not be rigidly prescribed but should reflect input by the individual investigatior.
关键试验是用于评估药物对马的主要体内寄生虫(胃蝇蛆、蛔虫、大型圆线虫、小型圆线虫和蛲虫)疗效的主要方法。关键试验可确定:(1)活性谱,(2)清除效果,(3)排出模式,以及(4)这些寄生虫各物种的身体状况。简要讨论了马主要寄生虫病的一般特征。还考虑了关键试验的标准,包括:(1)试验次数,(2)菌株变异和耐药性,(3)试验马的选择,(4)寄生虫物种的诊断,(5)寄生虫数量,(6)最低疗效要求,以及(7)其他寄生虫物种。对照试验主要在选定的基础上用于消化道近端的小型线虫,这些线虫无法通过关键试验进行适当评估,或用于其他有限目的。简要讨论了临床试验,但在全面评估一种药物作为新产品或其临床使用中的持续有效性时,临床试验是对关键试验和对照试验的宝贵补充。进行药物评估所采用的实验程序不应严格规定,而应反映个体研究者的意见。