RESUMO
The presence of health issues (diarrhea, poor body condition) in non-human primates can impact animal welfare, confound toxicity study data, and lead to animal exclusion from studies. A working group cosponsored by DruSafe and 3Rs Translational and Predictive Sciences Leadership Groups of the IQ Consortium conducted a survey to benchmark quarantine, pre-study screening, husbandry, and veterinary care practices and their impact on NHP health. Nineteen companies participated in the survey providing separate responses for studies conducted in-house and at Contract Research Organizations from 3 regions (North America (NA), Europe and Asia) for an aggregate of 33 responses. A majority of responding companies conducted studies at North America CROs (39%) or in-house (36%) using primarily Chinese (33%) or Cambodian (27%) and to a lesser extent Vietnam (18%) or Mauritian (15%) origin NHPs. Forty-Five percent of responses had pre-study health issues (fecal abnormalities, etc.) on ≥ 1 studies with the highest incidence observed in Vietnam origin NHPs (80%). The survey suggested variable pre-screening and quarantine practices across facilities. Husbandry practices including behavioral assessments, environmental enrichment and consistent diets were associated with a lower incidence of health issues. The survey also benchmarked approaches used to diagnose and manage abnormal feces in NHPs and has provided strategies to minimize impact on NHP health. The survey highlighted opportunities for harmonizing screening criteria across industry and for improving tracking and sharing of health screening results, leading to further refinement of NHP veterinary care practices, higher quality studies, and reduced NHP use.
Assuntos
Benchmarking , Primatas , Animais , Bem-Estar do Animal , Inquéritos e QuestionáriosRESUMO
A clinical veterinarian working in a safety assessment testing facility must balance animal welfare concerns with the attainment of sound, reproducible data necessary for regulatory studies. Drawing on her experience as a clinical veterinarian with specialty training in the field of toxicology, and past experience as a Study Director on safety assessment studies, the author describes practices that facilitate the veterinarian's role to ensure animal welfare on safety assessment studies.
Assuntos
Comitês de Cuidado Animal/organização & administração , Experimentação Animal/normas , Bem-Estar do Animal/normas , Ciência dos Animais de Laboratório/métodos , Médicos Veterinários , Experimentação Animal/legislação & jurisprudência , Bem-Estar do Animal/legislação & jurisprudência , Estados Unidos , United States Department of Agriculture , United States Food and Drug AdministrationRESUMO
Best practices result from a partnership between law, science, and the people working with the animals on regulated studies. In an ideal setting, people working with animals observe and study animal behavior as influenced by different housing and handling paradigms. These observations are published to create a body of science, and laws are promulgated based on the science. The ideal world does not exist, but there are certain components of best practices common to all species. These components include study design, housing, social contact, diet/feed, enrichment devices, and human interaction. This paper outlines how the forces of law, science, and people work to create best practices for species in regulated studies, specifically mice, rats, rabbits, dogs, and nonhuman primates.