Does the admission procedure lack the fourth hurdle (socio-economic criteria)?

H J Hapke
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Abstract

Besides the 3 aspects of drug safety, ie stability, efficacy and harmlessness, a fourth hurdle for veterinary drug licensing is discussed: socio-economic criteria. These criteria have not yet been established and the scientific aspects are difficult to define. After discussion of the advantages and disadvantages of the fourth hurdle, the conclusion is that there is no need to introduce a fourth criterion into the admission procedure for veterinary drugs, feed additives or any other chemicals which increase animal health or promote their growth.

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入学程序是否缺少第四个障碍(社会经济标准)?
除了药品安全性的稳定性、有效性和无害性这三个方面,本文还讨论了兽药许可的第四个障碍:社会经济标准。这些标准尚未确立,科学方面也难以界定。在讨论了第四个障碍的利弊之后,结论是没有必要在兽药、饲料添加剂或任何其他提高动物健康或促进动物生长的化学品的准入程序中引入第四个标准。
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