Minimisation of dog use in the safety assessment of pharmaceuticals: Progress with the EFPIA/RSPCA/FRAME dog project

Critical evaluation of the use of dogs in biomedical research and testing in Europe

“…thus, a preliminary prediction of dose levels for 14-or 28-day studies can be made based on a low number of animals used (9-12 animals showed best results). After a thorough review, harmonization of the principal study design was proposed, which led to a reduction in dog use by applying the optimized design and endpoints (Smith et al, 2005) Phase 2 consisted of a data-sharing initiative to avoid unnecessary duplication of studies within pesticide, chemical and pharmaceutical sectors. the authors also supported the development of a central database of animal experiments, including a vehicle database containing in vivo toxicological information on non-active formulation ingredients (vehicles, solvents, excipients, preservatives, etc.)…”

“…A 2006 survey in the UK showed that the removal of control recovery groups might be able to save 120 dogs per year, but some companies are still concerned about the scientific and regulatory repercussions of that question (Smith et al, 2007).…”