A good practice guide to the administration of substances and removal of blood, including routes and volumes

This article is the result of an initiative between the European Federation of Pharmaceutical Industries Associations (EFPIA) and the European Centre for the Validation of Alternative Methods (ECVAM). Its objectives are to pr ovide the researcher in the safety evaluation laboratory with an up-to-date , easy-to-use set of data sheets to aid in the study design process whilst at the same time affording maximum welfare considerations to the experiment al animals. Although this article is targeted at researchers in the European Pharmaceut ical Industry, it is considered that the principles underpinning the data s ets and refinement proposals are equally applicable to all those who use th ese techniques on animals in their research, whether in research institutes , universities or other sectors of industry. The implications of this artic le may lead to discussion with regulators, such as those responsible for ph armacopoeial testing. There are numerous publications dealing with the administration of test sub stances and the removal of blood samples, and many laboratories also have t heir own 'in-house' guidelines that have been developed by custom and pract ice over many Sears. Within European Union Directive 86/609EEC(1) we have a n obligation to refine experiments to cause the minimum amount of stress, W e hope that this article will provide background data useful to those respo nsible for protocol design and review. This guide is based on peer-reviewed publications whenever possible, but wh ere this is not possible we have used 'in-house' data and the experience of those on the working party (as well as helpful comments submitted by the i ndustry) for a final opinion. The guide also addresses the continuing need to refine the techniques associated with the administration of substances a nd the withdrawal of blood, and suggests ways of doing so. Data-sharing bet ween laboratories should be encouraged to avoid duplication of animal work, as a cll as sharing practical skills concerning animal welfare and scienti fic problems caused by 'overdosing' in some way or another, The recommendat ions in this guide refer to the 'normal' animal, and special consideration is needed, for instance, during pregnancy and lactation. Interpretation of studies may be confounded when large volumes are administered or excessive sampling employed, particularly if anaesthetics are used. Copyright (C) 200 1 John Wiley & Sons, Ltd.