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Social housing of non-rodents during cardiovascular recordings in safety pharmacology and toxicology studies.
Prior, Helen; Bottomley, Anna; Champéroux, Pascal; Cordes, Jason; Delpy, Eric; Dybdal, Noel; Edmunds, Nick; Engwall, Mike; Foley, Mike; Hoffmann, Michael; Kaiser, Robert; Meecham, Ken; Milano, Stéphane; Milne, Aileen; Nelson, Rick; Roche, Brian; Valentin, Jean-Pierre; Ward, Gemma; Chapman, Kathryn.
Afiliação
  • Prior H; National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), UK. Electronic address: helen.prior@nc3rs.org.uk.
  • Bottomley A; National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), UK.
  • Champéroux P; Centre de Recherches Biologiques (CERB), France.
  • Cordes J; Pfizer, USA.
  • Delpy E; Biotrial, France.
  • Dybdal N; Genentech, USA.
  • Edmunds N; AstraZeneca, UK.
  • Engwall M; Amgen, USA.
  • Foley M; Covance, USA.
  • Hoffmann M; Bayer, Germany.
  • Kaiser R; Charles River Laboratories, USA.
  • Meecham K; Envigo, UK.
  • Milano S; WIL Research, France.
  • Milne A; Charles River Laboratories, UK.
  • Nelson R; Abbvie, USA.
  • Roche B; WIL Research, USA.
  • Valentin JP; UCB Pharma, Belgium.
  • Ward G; GlaxoSmithKline, UK.
  • Chapman K; National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), UK.
Article em En | MEDLINE | ID: mdl-27039257
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Meio Social / Hemodinâmica / Abrigo para Animais Tipo de estudo: Guideline Aspecto: Determinantes_sociais_saude Limite: Animals Idioma: En Revista: J Pharmacol Toxicol Methods Assunto da revista: FARMACOLOGIA / TOXICOLOGIA Ano de publicação: 2016 Tipo de documento: Article País de publicação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Meio Social / Hemodinâmica / Abrigo para Animais Tipo de estudo: Guideline Aspecto: Determinantes_sociais_saude Limite: Animals Idioma: En Revista: J Pharmacol Toxicol Methods Assunto da revista: FARMACOLOGIA / TOXICOLOGIA Ano de publicação: 2016 Tipo de documento: Article País de publicação: Estados Unidos