The use of veterinary drugs in food‐producing animals may result in the presence of low levels of drug residues in these edible, animal‐derived foods, with potential dietary exposure to humans. Since therapeutic doses of antibiotics have been shown to affect bacterial populations in the gastrointestinal tract microbiome and can also promote the emergence of antibiotic‐resistant bacteria, there is concern that animal drugs at residue level concentrations could also perturb the intestinal microbiome composition and modify the antimicrobial resistance profile of the human intestinal microbiota. This review provides updated information on the VICH GL#36(R2), on evaluating the safety of veterinary drug residues in animal‐derived foods and their effects on the human intestinal microbiome; discusses critical research knowledge gaps and challenges in evaluating the impact of drug residues in animal‐derived foods on the human intestinal microbiome; and analyzes integrated basic and applied research approaches, currently being conducted at FDA, on studies that specifically address key regulatory science questions. Moreover, this review aims to emphasize future research needs on scientific methodology and provides general recommendations on drug inactivation, bioavailability, and antimicrobial resistance, to improve the safety evaluation and risk assessment of antimicrobial residues and their impact on the gastrointestinal microbiota, with the goal of ensuring food safety.

中文翻译：

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动物源性食品中的抗菌药物残留：对人体肠道微生物组的潜在影响

在食用动物中使用兽药可能会导致这些可食用的动物源性食品中存在低水平的药物残留，并可能导致人类通过膳食接触。由于治疗剂量的抗生素已被证明会影响胃肠道微生物组中的细菌种群，并且还可以促进抗生素耐药细菌的出现，因此有人担心残留水平的动物药物也会扰乱肠道微生物组的组成并改变抗菌药物人类肠道微生物群的耐药性概况。本综述提供了 VICH GL#36(R2) 的最新信息，评估动物源性食品中兽药残留的安全性及其对人体肠道微生物群的影响；讨论评估动物源性食品中药物残留对人体肠道微生物组影响的关键研究知识差距和挑战；并分析目前在 FDA 进行的综合基础和应用研究方法，研究专门解决关键监管科学问题。此外，本综述旨在强调未来对科学方法的研究需求，并就药物灭活、生物利用度和抗菌素耐药性提供一般性建议，以改进抗菌素残留及其对胃肠道微生物群的影响的安全性评价和风险评估，目标是确保食品安全。目前正在 FDA 进行的研究专门解决关键的监管科学问题。此外，本综述旨在强调未来对科学方法的研究需求，并就药物灭活、生物利用度和抗菌素耐药性提供一般性建议，以改进抗菌素残留及其对胃肠道微生物群的影响的安全性评价和风险评估，目标是确保食品安全。目前正在 FDA 进行的研究专门解决关键的监管科学问题。此外，本综述旨在强调未来对科学方法的研究需求，并就药物灭活、生物利用度和抗菌素耐药性提供一般性建议，以改进抗菌素残留及其对胃肠道微生物群的影响的安全性评价和风险评估，目标是确保食品安全。