European law requires that experiments using animals go through a process of refinement before being conducted. The two papers presented by Dr. David Smith and Dr. Jon Richmond cover topics relating to laws and available guides and organizations that assist in the refinement process specifically for toxicology testing.
Dr. Smith's paper introduces the European Centre for the Validation of Alternative Methods (ECVAM) and The European Federation of Pharmaceutical Industries' Associations (EFPIA), which have together produced a "best practice" guide on the administration of substances in preclinical safety evaluation. In Dr. Smith's paper, details of the guide are presented including the guide's objectives, factors affecting the development of the guide, useful tables of best practice administration volumes and routes by common laboratory species, and a "decision tree" for selecting the optimal vehicle of delivery.
Smith emphasizes the correlations between refinement, validity of scientific data and ethical concerns. An example of a refinement technique is his recommendation that small-scale pilot studies be carried out on any new formulation before committing to larger-scale studies. He also discusses the use of setting a "limit dose" to substances. If a limit dose is exceeded, there could be scientific and welfare implications.
Dr. Richmond's paper presents a summary of findings from the British Home Office on elements of standardizing procedures and identifying best practices in toxicology testing within Britain. Specifically, this paper details refinements in terms of recommended limited dosing volumes per species, frequency and route. He discusses the implications of using these "best practices" for the enhanced welfare of the animal and for good scientific practices.
The full text of these papers is available in PDF format:
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