Preclinical safety evaluation using nonrodent species: an industry/welfare project to minimize dog use.
This review of the dog, the primary nonrodent species used in toxicology, and its use in the safety evaluation of pharmaceuticals, provides data on the number used in particular projects in an effort to establish a baseline from which some minimization can be measured. Opportunities for reduction and replacement, as identified by a European Industry/Welfare Steering Group, are discussed. The three distinct areas of potential approaches to minimize dog use are categorized as industrial cooperation/data sharing, achieving best practice in study design, and assessing the need for a particular study. The Steering Group prioritized the approaches based on the impact on the number of animals used, the impact on the welfare of the remaining animals, the potential for industry's acceptance of the scientific approach, the potential for regulators' acceptance of the validated approach, and the time/cost of evaluation or implementation. Examples of each category are presented, and the work needed to facilitate industry/regulatory change is discussed.
Smith
David
D
Toxicology, AstraZeneca, Cheshire, UK.
Broadhead
Caren
C
Descotes
Gerard
G
Fosse
Richard
R
Hack
Ruediger
R
Krauser
Klaus
K
Pfister
Rudolf
R
Phillips
Barry
B
Rabemampianina
Yvon
Y
Sanders
James
J
Sparrow
Sue
S
Stephan-Gueldner
Markus
M
Jacobsen
Soren Dyring
SD
D000826:Animal Testing Alternatives; D000827:Animal Welfare; D000818:Animals; D004285:Dogs; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D018675:Toxicity Tests / Q000379:methods*