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Licensing and Approval of Antimicrobial Agents for Use in Animals

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  • Authors: Constança Pomba1, Boudewijn Catry2, Jordi Torren Edo3, Helen Jukes4
  • Editors: Frank Møller Aarestrup5, Stefan Schwarz6, Jianzhong Shen7, Lina Cavaco8
  • VIEW AFFILIATIONS HIDE AFFILIATIONS
    Affiliations: 1: Faculty of Veterinary Medicine, University of Lisbon and Antimicrobial and Biocide Resistance Laboratory, Centre for Interdisciplinary Research in Animal Health (CIISA), Lisbon, Portugal; 2: Sciensano, Brussels, Belgium; 3: European Medicines Agency, London, UK and Facultat de Veterinària, UAB, Cerdanyola del Vallès, Spain; 4: Veterinary Medicines Directorate, Addlestone, UK; 5: Technical University of Denmark, Lyngby, Denmark; 6: Freie Universität Berlin, Berlin, Germany; 7: China Agricultural University, Beijing, China; 8: Statens Serum Institute, Copenhagen, Denmark
  • Source: microbiolspec August 2018 vol. 6 no. 4 doi:10.1128/microbiolspec.ARBA-0016-2017
  • Received 05 April 2017 Accepted 21 February 2018 Published 02 August 2018
  • Constança Pomba, [email protected]
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  • Abstract:

    The importance of antimicrobial resistance and the urgent need to combat it has increased the already existent complexity of licensing and approval of antimicrobial agents for use in animals due to its possible impact on animal and public health. VICH—the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products—is the trilateral (European Union-Japan-United States) program that has the goal of harmonizing technical requirements for veterinary product registration. This article aims to describe the data requirements and testing necessary to build a registration file to obtain marketing authorization for a new antimicrobial agent for use in animals. This information is needed in the context of the risk assessment framework currently used in the approval of veterinary medicinal products containing antimicrobial substances. This framework considers the consequences of the uncontrolled quality of the antimicrobial product, the direct exposure of people to the antimicrobial product (human occupational safety and consumer safety), inadvertent exposure of organisms to the antimicrobial product (environmental safety), the antimicrobial product causing harm in the treated animals (target animal safety), and failure to achieve claims (efficacy). Approved veterinary medicines need to have a clear positive benefit associated with their use because of the risk to public health, animal health, and the environment. However, the presence of antimicrobials in the environment exerts a selective pressure for resistance genes in bacteria, and there is growing worldwide concern about the role of polluted soil and water environments in spreading antimicrobial resistance and the role of the contaminant resistome due to food-producing animal antimicrobial treatment. Additionally, the international developments regarding the categorization of critically important antimicrobials with the possible restrictions of use and the monitoring and surveillance of antimicrobial resistance in animals are reviewed.

  • Citation: Pomba C, Catry B, Edo J, Jukes H. 2018. Licensing and Approval of Antimicrobial Agents for Use in Animals. Microbiol Spectrum 6(4):ARBA-0016-2017. doi:10.1128/microbiolspec.ARBA-0016-2017.

References

1. Randell AW, Whitehead AJ. 1997. Codex Alimentarius: food quality and safety standards for international trade. Rev Sci Tech 16:313–321 http://dx.doi.org/10.20506/rst.16.2.1019. [PubMed]
2. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2003. VICH Harmonized Tripartite Guideline GL27. Guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/antimicrobial-safety.html.
3. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2008. VICH Harmonized Tripartide GL43. Target animal safety for veterinary pharmaceutical products. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/environmental-safety.html.
4. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration Center For Veterinary Medicine. 1996. CVM GFI #49. Target animal safety and drug effectiveness studies for anti-microbial bovine mastitis products (lactating and non-lactating cow products). https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm053411.htm.
5. European Medicines Agency. 2017. Guideline on the conduct of efficacy studies for intramammary products for use in cattle. EMA/CVMP/344/1999-Rev.2. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/01/WC500220206.pdf.
6. Storey S. 2005. Challenges with the development and approval of pharmaceuticals for fish. AAPS J 7:E335–E343 http://dx.doi.org/10.1208/aapsj070232. [PubMed]
7. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2001. VICH harmonized tripartide guideline GL6. Environmental impact assessment (EIAS) for veterinary medicinal products (VMPS) - ECOTOXICITY PHASE I. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/environmental-safety.html.
8. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2004. VICH harmonized tripartide GL38. Environmental impact assessment (EIAs) for veterinary medicinal products (VMPs): ecotoxicity phase II. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/environmental-safety.html.
9. Joint FAO/WHO Expert Committee on Food Additives (JECFA). 2016. Guidance document for the establishment of acute reference dose (ARfD) for veterinary drug residues in food. http://www.who.int/foodsafety/chem/jecfa/Guidance_ARfD.pdf.
10. Spaepen KRI, Van Leemput LJJ, Wislocki PG, Verschueren C. 1997. A uniform procedure to estimate the predicted environmental concentration of the residues of veterinary medicines in soil. Environ Toxicol Chem 16:1977–1982 http://dx.doi.org/10.1002/etc.5620160930.
11. Manaia CM. 2017. Assessing the risk of antibiotic resistance transmission from the environment to humans: non-direct proportionality between abundance and risk. Trends Microbiol 25:173–181 http://dx.doi.org/10.1016/j.tim.2016.11.014. [PubMed]
12. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2009. VICH harmonized tripartide guideline GL33. Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
13. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2002. VICH harmonized tripartite guideline GL31. Studies to evaluate the safety of residues of veterinary drugs in human food: repeat-dose (90-day) toxicity testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
14. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2004. VICH harmonized tripartite guideline GL37. Studies to evaluate the safety of residues of veterinary drugs in human food: repeat-dose (chronic) toxicity testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
15. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2001. VICH harmonized tripartite guideline GL22. Studies to evaluate the safety of residues of veterinary drugs in human food: reproduction testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
16. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2001. VICH harmonized tripartite guideline GL23. Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
17. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2002. VICH harmonized tripartite guideline GL32. Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
18. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2012. VICH harmonized tripartite guideline GL36. Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/antimicrobial-safety.html.
19. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2016. VICH harmonized tripartide GL54. Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD). http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
20. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2011. VICH harmonized tripartite guideline GL46.Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/metabolism-and-residue-kinetics.html.
21. European Medicines Agency. 2016. Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances. EMA/CVMP/627/2001-Rev.1. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/02/WC500200984.pdf.
22. European Medicines Agency. 2010. Guideline on statistical principles for veterinary clinical trials. EMA/CVMP/EWP/81976/2010. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500097081.pdf.
23. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). 2000. VICH harmonized tripartite guideline GL9. Good clinical practice. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-efficacy/good-clinical-practice.html.
24. Australian Pesticides and Veterinary Medicines Authority. 2009. Veterinary Manual of requirements and guidelines. Part 10. Special data: antibiotic resistance.
25. Graveland H, Wagenaar JA, Heesterbeek H, Mevius D, van Duijkeren E, Heederik D. 2010. Methicillin resistant Staphylococcus aureus ST398 in veal calf farming: human MRSA carriage related with animal antimicrobial usage and farm hygiene. PLoS One 5:e10990 http://dx.doi.org/10.1371/journal.pone.0010990. [PubMed]
26. Persoons D, Haesebrouck F, Smet A, Herman L, Heyndrickx M, Martel A, Catry B, Berge AC, Butaye P, Dewulf J. 2011. Risk factors for ceftiofur resistance in Escherichia coli from Belgian broilers. Epidemiol Infect 139:765–771 http://dx.doi.org/10.1017/S0950268810001524. [PubMed]
27. Vose D, Acar J, Anthony F, Franklin A, Gupta R, Nicholls T, Tamura Y, Thompson S, Threlfall EJ, van Vuuren M, White DG, Wegener HC, Costarrica ML, Office International des Epizooties ad hoc Group. 2001. Antimicrobial resistance: risk analysis methodology for the potential impact on public health of antimicrobial resistant bacteria of animal origin. Rev Sci Tech 20:811–827 http://dx.doi.org/10.20506/rst.20.3.1319. [PubMed]
28. World Organisation for Animal Health (OIE). 2011. Terrestrial Animal Health Code, chapter 6.10. www.oie.int/doc/ged/D10905.pdf.
29. Codex Alimentarius Commission. 2005. Code of practice to minimize and contain antimicrobial resistance. CAC/RCP 61-2005. http://www.fao.org/input/download/standards/10213/CXP_061e.pdf.
30. Codex Alimentarius Commission. 2011. Guidelines for risk analysis of foodborne antimicrobial resistance. CAC/GL 77-2011. www.fao.org/input/download/standards/11776/CXG_077e.pdf.
31. World Trade Organization. 2018. The WTO agreement on the application of sanitary and phytosanitary measures (SPS agreement). https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm#fnt1.
32. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine. 2003. Evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern. CVM GFI # 152. https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052519.pdf.
33. European Medicines Agency. 2015. Guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals. EMA/CVMP/AWP/706442/2013. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500183774.pdf.
34. Health Canada, Veterinary Drugs Directorate. 2005. Current thinking on risk management measures to address antimicrobial resistance associated with the use of antimicrobial agents in food-producing animals. http://www.hc-sc.gc.ca/dhp-mps/vet/antimicrob/amr-ram_rep-rap_06_05-eng.php.
35. Joint Expert Technical Advisory Committee on Antibiotic Resistance (JETACAR). 1999. The Use of Antibiotics in Food-Producing Animals: Antibiotic-Resistant Bacteria in Animals and Humans. Appendix 8. Antibiotic imports to Australia, 1992-97. Commonwealth Department of Health and Aged Care and Commonwealth Department of Agriculture, Fisheries and Forestry, Canberra, Australia.
36. EMEA/CVMP. 2006. Reflection paper on the use of fluoroquinolones in food producing animals: precautions for use in the SPC regarding prudent use guidance. EMEA/CVMP/416168/2006-FINAL). http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf.
37. EMEA/CVMP. 2009. Revised reflection paper on the use of 3rd and 4th generation cephalosporins in food producing animals in the European Union: development of resistance and impact on human and animal health. EMEA/CVMP/SAGAM/81730/2006-Rev.1. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004307.pdf.
38. EMA/CVMP. 2011. Reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf.
39. EMA/CVMP. 2010. Opinion following an Article 35 referral for all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Quinolones_containing_medicinal_products/vet_referral_000039.jsp&mid=WC0b01ac05805c5170.
40. EMA/CVMP. 2012. Opinion following an Article 35 referral for all veterinary medicinal products containing systemically administered (parenteral and oral) 3rd and 4th generation cephalosporins intended for use in food producing species. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Cephalosporins/vet_referral_000056.jsp&mid=WC0b01ac05805c5170.
41. European Medicines Agency. 2013. Reflection paper on the risk of antimicrobial resistance transfer from companion animals. EMA/CVMP/AWP/401740/2013. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500181642.pdf.
42. Pomba C, Rantala M, Greko C, Baptiste KE, Catry B, van Duijkeren E, Mateus A, Moreno MA, Pyörälä S, Ružauskas M, Sanders P, Teale C, Threlfall EJ, Kunsagi Z, Torren-Edo J, Jukes H, Törneke K. 2017. Public health risk of antimicrobial resistance transfer from companion animals. J Antimicrob Chemother 72:957–968. [PubMed]
43. World Health Organization, Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR). 2016. Critically Important Antimicrobials for Human Medicine, 4th rev. 2013. http://apps.who.int/iris/bitstream/10665/251715/1/9789241511469-eng.pdf?ua=1.
44. WHO. 2017. WHO guidelines on use of medically important antimicrobials in food-producing animals. World Health Organization, Geneva, Switzerland.
45. World Organisation for Animal Health. 2015. OIE list of antimicrobial agents of veterinary importance. http://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/Eng_OIE_List_antimicrobials_May2015.pdf.
46. European Medicines Agency. 2014. Answers to the requests for scientific advice on the impact on public health and animal health of the use of antibiotics in animals. EMA/381884/2014. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/07/WC500170253.pdf.
47. European Medicines Agency. 2016. Sales of veterinary antimicrobial agents in 29 European countries in 2014. EMA/61769/2016. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2016/10/WC500214217.pdf.
48. European Medicines Agency, Committee for Medicinal Products for Veterinary Use (EMA/CVMP). Opinion following an Article 35 referral for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species. http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Colistin_35/WC500093733.pdf.
49. Catry B, Cavaleri M, Baptiste K, Grave K, Grein K, Holm A, Jukes H, Liebana E, Navas AL, Mackay D, Magiorakos A-P, Romo MAM, Moulin G, Madero CM, Pomba MCMF, Powell M, Pyörälä S, Rantala M, Ružauskas M, Sanders P, Teale C, Threlfall EJ, Törneke K, Van Duijkeren E, Torren Edo J. 2015. Use of colistin-containing products within the European Union and European Economic Area (EU/EEA): development of resistance in animals and possible impact on human and animal health. Int JAntimicrob Agents 46:297–306. [PubMed]
50. Catry B, Threlfall J. 2009. Critically important antimicrobial--or not? Clin Infect Dis 49:1961–1962, author reply 1962–1963 http://dx.doi.org/10.1086/648502.
51. RONAFA. 2017. EMA and EFSA Joint Scientific Opinion on measures to reduce the need to use antimicrobial agents in animal husbandry in the European Union, and the resulting impacts on food safety. EFSA J 15:e4666. doi:10.2903/j.efsa.2017.4666.
52. Pardon B. 2012. Morbidity, mortality and drug use in white veal calves with emphasis on respiratory disease. PhD thesis, Ghent University, Ghent, Belgium.
53. Catry B, Duchateau L, Van de Ven J, Laevens H, Opsomer G, Haesebrouck F, De Kruif A. 2008. Efficacy of metaphylactic florfenicol therapy during natural outbreaks of bovine respiratory disease. J Vet Pharmacol Ther 31:479–487 http://dx.doi.org/10.1111/j.1365-2885.2008.00981.x. [PubMed]
54. Filippitzi ME, Sarrazin S, Imberechts H, Smet A, Dewulf J. 2016. Risk of cross-contamination due to the use of antimicrobial medicated feed throughout the trail of feed from the feed mill to the farm. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 33:644–655 10.1080/19440049.2016.1160442.
55. Catry B, Dewulf J, Maes D, Pardon B, Callens B, Vanrobaeys M, Opsomer G, de Kruif A, Haesebrouck F. 2016. Effect of antimicrobial consumption and production type on antibacterial resistance in the bovine respiratory and digestive tract. PLoS One 11:e0146488 http://dx.doi.org/10.1371/journal.pone.0146488. [PubMed]
56. Barnum DA, Newbould FH. 1961. The use of the California mastitis test for the detection of bovine mastitis. Can Vet J 2:83–90. [PubMed]
57. Giguère S. 2017. Treatment of infections caused by Rhodococcus equi. Vet Clin North Am Equine Pract 33:67–85. [PubMed]
58. NethMap. 2016. Consumption of antimicrobial agents and antimicrobial resistance among medically important bacteria in The Netherlands in 2015. http://www.wur.nl/upload_mm/0/b/c/433ca2d5-c97f-4aa1-ad34-a45ad522df95_92416_008804_NethmapMaran2016+TG2.pdf.
59. Hanon J-B, Jaspers S, Butaye P, Wattiau P, Méroc E, Aerts M, Imberechts H, Vermeersch K, Van der Stede Y. 2015. A trend analysis of antimicrobial resistance in commensal Escherichia coli from several livestock species in Belgium (2011-2014). Prev Vet Med 122:443–452 http://dx.doi.org/10.1016/j.prevetmed.2015.09.001. [PubMed]
60. Catry B, Van Duijkeren E, Pomba MC, Greko C, Moreno MA, Pyörälä S, Ruzauskas M, Sanders P, Threlfall EJ, Ungemach F, Törneke K, Munoz-Madero C, Torren-Edo J, Scientific Advisory Group on Antimicrobials (SAGAM). 2010. Reflection paper on MRSA in food-producing and companion animals: epidemiology and control options for human and animal health. Epidemiol Infect 138:626–644 http://dx.doi.org/10.1017/S0950268810000014. [PubMed]
61. DANMAP. 2016. DANMAP 2015: Use of Antimicrobial Agents and Occurrence of Antimicrobial Resistance in Bacteria from Food Animals, Food and Humans in Denmark. http://www.danmap.org/∼/media/Projekt%20sites/Danmap/DANMAP%20reports/DANMAP%20%202015/DANMAP%202015.ashx.
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2018-08-02
2018-08-16

Abstract:

The importance of antimicrobial resistance and the urgent need to combat it has increased the already existent complexity of licensing and approval of antimicrobial agents for use in animals due to its possible impact on animal and public health. VICH—the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products—is the trilateral (European Union-Japan-United States) program that has the goal of harmonizing technical requirements for veterinary product registration. This article aims to describe the data requirements and testing necessary to build a registration file to obtain marketing authorization for a new antimicrobial agent for use in animals. This information is needed in the context of the risk assessment framework currently used in the approval of veterinary medicinal products containing antimicrobial substances. This framework considers the consequences of the uncontrolled quality of the antimicrobial product, the direct exposure of people to the antimicrobial product (human occupational safety and consumer safety), inadvertent exposure of organisms to the antimicrobial product (environmental safety), the antimicrobial product causing harm in the treated animals (target animal safety), and failure to achieve claims (efficacy). Approved veterinary medicines need to have a clear positive benefit associated with their use because of the risk to public health, animal health, and the environment. However, the presence of antimicrobials in the environment exerts a selective pressure for resistance genes in bacteria, and there is growing worldwide concern about the role of polluted soil and water environments in spreading antimicrobial resistance and the role of the contaminant resistome due to food-producing animal antimicrobial treatment. Additionally, the international developments regarding the categorization of critically important antimicrobials with the possible restrictions of use and the monitoring and surveillance of antimicrobial resistance in animals are reviewed.

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Figures

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FIGURE 1

Partial decision tree/flow diagram for veterinary medicinal products used for aquaculture according to the Ecotoxicity Phase II VICH Harmonized Tripartide Guideline GL38 ( 8 ).

Source: microbiolspec August 2018 vol. 6 no. 4 doi:10.1128/microbiolspec.ARBA-0016-2017
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Image of FIGURE 2
FIGURE 2

Chain of events that may lead from use of antimicrobials in animals to a compromised antimicrobial treatment in humans.

Source: microbiolspec August 2018 vol. 6 no. 4 doi:10.1128/microbiolspec.ARBA-0016-2017
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Tables

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TABLE 1

Derivation of ADI from data

Source: microbiolspec August 2018 vol. 6 no. 4 doi:10.1128/microbiolspec.ARBA-0016-2017
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TABLE 2

Risk analysis frameworks in the approval of veterinary medicinal products containing antimicrobial substances

Source: microbiolspec August 2018 vol. 6 no. 4 doi:10.1128/microbiolspec.ARBA-0016-2017
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TABLE 3

Summary of WHO recommendations on use of medically important antimicrobials in food-producing animals

Source: microbiolspec August 2018 vol. 6 no. 4 doi:10.1128/microbiolspec.ARBA-0016-2017
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TABLE 4

Categories of antimicrobials according to the annex of the FDA guidance

Source: microbiolspec August 2018 vol. 6 no. 4 doi:10.1128/microbiolspec.ARBA-0016-2017

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