ECVAM/2000/26 Improving the application of quantitative methods in validation work
The acceptance of quantitative methods in in-vitro studies has seen a steady increase over the last five years. ECVAM's Biostatistics Task Force report in the mid-1990s (Holzhutter et al., 1996) laid out clear guidelines for biologists in this field. Nevertheless, the application of more formal approaches to experimental design and statistical analysis is still far from complete in many studies. Furthermore, the regulatory paradigm often does not encourage the use of standard statistical techniques; for example, lowest detectable concentration levels in assays are defined in international guidelines as a simple multiple of standard deviation, rather than tests which are accepted in the statistical field as more reliable and more powerful. ECVAM -through the Biostatistics and Experimental Design Task Force -is currently defining a new approach to facilitate the improved acceptance of these methods into the development and validation process. This will cover a review of appropriate quantitative approaches that can be applied in the validation of alternative methods, as well as an educational element for the community as a whole. Furthermore, the Task Force programme will address the regulatory acceptance of these approaches.
Bibliographic Reference: Oral Report delivered at: INVITOX 2000, hosted by: European Society of Toxicology In Vitro, Alicante (ES) 25-28 October 2000
Record Number: 200013022 / Last updated on: 2001-01-24
Original language: en
Available languages: en