References
- European Commission [EC]. 2009. Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council. OJ. L. 152:11–22.
- European Commission [EC]. 2010. Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin. OJ. L. 15:1–72.
- European Medicines Agency [EMA]. 2022. Guideline on determination of withdrawal periods for edible tissues, EMA/CVMP/SWP/735325/2012 Rev.2; [accessed 2023 Jan 20]. https://www.ema.europa.eu/en/documents/scientific-guideline/adopted-guideline-determination-withdrawal-periods-edible-tissues-revision-2_en.pdf.
- European Medicines Agency [EMA]. 2021. Guideline on determination of withdrawal periods for milk, EMA/CVMP/SWP/735418/2012 Rev.1; [accessed 2023 Jan 20]. https://www.ema.europa.eu/en/documents/scientific-guideline/adopted-guideline-determination-withdrawal-periods-milk-revision-1_en.pdf.
- European Union [EU]. 2017. Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products. OJ. L 095:1–163.
- European Union [EU]. 2019. Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC. Pe/45/2018/Rev/1. OJ. L 4:43–167.
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products [VICH]. 2015. VICH guideline 49: Guidance for industry: studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: validation of analytical methods used in residue depletion studies; [accessed 2022 Aug 02]. https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl49-studies-evaluate-metabolism-residue-kinetics-veterinary-drugs-food-producing-animals_en.pdf.
- R Core Team. 2020. R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria; [accessed 2022 Aug 02]. https://www.r-project.org/index.html.
- Slob W. 1994. Uncertainty analysis in multiplicative models. Risk Anal. 14(4):571–576.
- U.S. Food and Drug Administration [FDA]. 2016. General principles for evaluating the human food safety of new animal drugs used in food-producing animals. Guidance for industry; [accessed 2022 Dec 13]. https://www.fda.gov/media/70028/download.
- Wallis WA. 1951. Tolerance intervals for linear regression. In: Neyman J, editor. Proceedings of the 2nd Berkeley Symposium on Mathematical Statistics and Probability, July 31–August 12, 1950. Vol. 2. Berkeley (CA): Statistical Laboratory of the University of California; p. 43–51.
- Young DS. 2010. Tolerance: an R package for estimating tolerance intervals. J Stat Program. 36(5):1–30.