Guideline limit volumes for dosing animals in the preclinical stage of safety evaluation

Guideline limit volumes for dosing laboratory animals by oral and parenteral routes in the preclinical stage of safety evaluation were agreed following discussions by the Toxicology Subcommittee of the Association of the British Pharmaceutical Industry. The guideline values represent common practice rather than absolute maxima. Whilst the guideline values are expected to be of value to scientists and technical staff involved in study design and applicable to the majority of routine safety evaluation studies, scope remains to make the case for special investigations. The need to carefully consider animal welfare and physiology, current legislation, the use of appropriate dosing technology and formulations, and other practical aspects of study conduct, is emphasised.