Office of Research, Division of Applied Veterinary Research, Center for Veterinary Medicine, Laurel, MD, USA.
J Vet Pharmacol Ther. 2021 Jan;44(1):58-67. doi: 10.1111/jvp.12897. Epub 2020 Aug 1.
This study was initiated to determine whether a comparative pharmacokinetic (PK) approach could be used to expand the pool of approved anthelmintics for minor ruminant species. Accordingly, the PK profiles of six anthelmintics (levamisole, albendazole, fenbendazole, moxidectin, doramectin, and ivermectin) in sheep, goats, and cattle were determined. The PK values determined for each anthelmintic included T , T , C , AUC, AUC/dose, and C /dose. The results of this study demonstrate that a comparative PK approach does not show commonality in the way these six anthelmintics are individually processed by these three ruminants. While some drugs demonstrated identical PK profiles between sheep and goats, none of these drugs demonstrated PK profiles in sheep and goats comparable to the PK profiles found in cattle. The results from this study suggest drug approval across these three ruminants is not a viable concept. However, the resulting PK profiles for each combination of drug and ruminant species represents a new dataset that can be used to support the US FDA Center for Veterinary Medicine's Minor Use/Minor Species indexing process for drug approvals in minor species such as sheep and goats.
这项研究旨在确定是否可以采用比较药代动力学(PK)方法来扩大已批准的小型反刍动物驱虫药的种类。因此,确定了六种驱虫药(左旋咪唑、阿苯达唑、芬苯达唑、莫昔克丁、多拉菌素和伊维菌素)在绵羊、山羊和牛中的 PK 特征。每种驱虫药的 PK 值包括 T 、 T 、 C 、 AUC、AUC/剂量和 C /剂量。本研究结果表明,比较 PK 方法并不能显示这六种驱虫药在这三种反刍动物中的个体处理方式具有共性。虽然有些药物在绵羊和山羊之间表现出相同的 PK 特征,但这些药物都没有在绵羊和山羊中表现出与牛中发现的 PK 特征相当的 PK 特征。本研究结果表明,在这三种反刍动物之间批准药物使用不是一个可行的概念。然而,每种药物与反刍动物种类组合的 PK 特征代表了一个新的数据集,可用于支持美国 FDA 兽医中心的小剂量/小物种索引过程,以批准绵羊和山羊等小型物种的药物使用。