Refinements in the care and use of animals in toxicology studies-regulation, validation, and progress.
During the past decade, important advances have been made in the humane care and use of laboratory animals used in toxicology studies, and there is strong international interest by the pharmaceutical sector in continuing with this progress. Because of the potential influence on human health, safety studies are highly regulated, and implementing refinements in laboratory animal care and use may require an initial validation study to demonstrate a lack of effect on study outcome. This paper provides an overview of issues surrounding implementation of animal care refinements in toxicology laboratory settings, including regulatory constraints, conducting validation studies, current progress in refinements, and areas for future consideration.
Turner
Patricia V
PV
Pfizer Global Research and Development--Sheridan Park Laboratories, 2270 Speakman Dr., Mississauga, Ontario L5K 1B4, Canada.
Smiler
Kathleen L
KL
Hargaden
Maureen
M
Koch
Michael A
MA
D035661:Animal Care Committees / Q000639:trends*; D000818:Animals; D007756:Laboratory Animal Science / Q000331:legislation & jurisprudence* / Q000379:methods*; D014116:Toxicology / Q000379:methods*