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Journal of pharmacological and toxicological methods
2016 Sep-Oct;81 75-87.

Social housing of non-rodents during cardiovascular recordings in safety pharmacology and toxicology studies.

Helen Prior, Anna Bottomley, Pascal Champéroux, Jason Cordes, Eric Delpy, Noel Dybdal, Nick Edmunds, Mike Engwall, Mike Foley, Michael Hoffmann, Robert Kaiser, Ken Meecham, Stéphane Milano, Aileen Milne, Rick Nelson, Brian Roche, Jean-Pierre Valentin, Gemma Ward, Kathryn Chapman
Author Information
  1. Helen Prior: National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), UK. Electronic address: helen.prior@nc3rs.org.uk.
  2. Anna Bottomley: National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), UK.
  3. Pascal Champéroux: Centre de Recherches Biologiques (CERB), France.
  4. Jason Cordes: Pfizer, USA.
  5. Eric Delpy: Biotrial, France.
  6. Noel Dybdal: Genentech, USA.
  7. Nick Edmunds: AstraZeneca, UK.
  8. Mike Engwall: Amgen, USA.
  9. Mike Foley: Covance, USA.
  10. Michael Hoffmann: Bayer, Germany.
  11. Robert Kaiser: Charles River Laboratories, USA.
  12. Ken Meecham: Envigo, UK.
  13. Stéphane Milano: WIL Research, France.
  14. Aileen Milne: Charles River Laboratories, UK.
  15. Rick Nelson: Abbvie, USA.
  16. Brian Roche: WIL Research, USA.
  17. Jean-Pierre Valentin: UCB Pharma, Belgium.
  18. Gemma Ward: GlaxoSmithKline, UK.
  19. Kathryn Chapman: National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), UK.
PMID: 27039257 DOI: 10.1016/j.vascn.2016.03.004

Abstract

INTRODUCTION: The Safety Pharmacology Society (SPS) and National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) conducted a survey and workshop in 2015 to define current industry practices relating to housing of non-rodents during telemetry recordings in safety pharmacology and toxicology studies. The aim was to share experiences, canvas opinion on the study procedures/designs that could be used and explore the barriers to social housing.
METHODS: Thirty-nine sites, either running studies (Sponsors or Contract Research Organisations, CROs) and/or outsourcing work responded to the survey (51% from Europe; 41% from USA).
RESULTS: During safety pharmacology studies, 84, 67 and 100% of respondents socially house dogs, minipigs and non-human primates (NHPs) respectively on non-recording days. However, on recording days 20, 20 and 33% of respondents socially house the animals, respectively. The main barriers for social housing were limitations in the recording equipment used, study design and animal temperament/activity. During toxicology studies, 94, 100 and 100% of respondents socially house dogs, minipigs and NHPs respectively on non-recording days. However, on recording days 31, 25 and 50% of respondents socially house the animals, respectively. The main barriers for social housing were risk of damage to and limitations in the recording equipment used, food consumption recording and temperament/activity of the animals.
CONCLUSIONS: Although the majority of the industry does not yet socially house animals during telemetry recordings in safety pharmacology and toxicology studies, there is support to implement this refinement. Continued discussions, sharing of best practice and data from companies already socially housing, combined with technology improvements and investments in infrastructure are required to maintain the forward momentum of this refinement across the industry.

Keywords

3Rs Dog Methods Minipig Non-human primate Non-rodents Safety pharmacology Social housing Telemetry Toxicology

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MeSH Term

Animals
Dogs
Drug Evaluation, Preclinical
Hemodynamics
Housing, Animal
Pharmacology
Primates
Safety
Social Environment
Surveys and Questionnaires
Swine
Swine, Miniature
Telemetry
Temperament
Toxicology
Journal Article
Article has an altmetric score of 2

Word Cloud

Created with Highcharts 10.0.0housingstudiessociallypharmacologyhouserecordingsafetytoxicologyrespondentsrespectivelydaysanimalsindustryrecordingsusedbarrierssocialSafetyResearchsurveynon-rodentstelemetrystudy100%dogsminipigsNHPsnon-recordingHowever20mainlimitationsequipmenttemperament/activityrefinementSocialINTRODUCTION:PharmacologySocietySPSNationalCentreReplacementRefinement&ReductionAnimalsNC3Rsconductedworkshop2015definecurrentpracticesrelatingaimshareexperiencescanvasopinionprocedures/designsexploreMETHODS:Thirty-ninesiteseitherrunningSponsorsContractOrganisationsCROsand/oroutsourcingworkresponded51%Europe41%USARESULTS:8467non-humanprimates33%designanimal94100312550%riskdamagefoodconsumptionCONCLUSIONS:AlthoughmajorityyetsupportimplementContinueddiscussionssharingbestpracticedatacompaniesalreadycombinedtechnologyimprovementsinvestmentsinfrastructurerequiredmaintainforwardmomentumacrosscardiovascular3RsDogMethodsMinipigNon-humanprimateNon-rodentsTelemetryToxicology

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