Recommendations for the Application of Biostatistical Methods during the Development and Validation of Alternative Toxicological Methods

Assessment of the relevance and reliability of alternative toxicological methods requires the application of biostatistical methods. This report contains the recommendations of the ECVAM Task Force on Biostatistics for the appropriate use of biometrical methods, and for closer collaboration between biostatisticians and experimental toxicologists in the development and validation of alternative methods. The main objectives of these recommendations are to improve the compatibility of the results obtained from different studies, and to prevent the misinterpretation of statistical analyses. The following points are discussed: a) the general importance of biostatistics in the development and validation of alternative tests; b) optimisation of study designs; c) statistical characterisation and processing of toxicological data; and d) the analysis of relationships which may exist between data obtained from various tests. In particular, the establishment of appropriate prediction models which are able to predict the toxic effects likely to occur in vivo from the results obtained in an in vitro test system is discussed. The members of the Task Force hope that this report will help to stimulate discussions among biostatisticians and experimental toxicologists about how the proper application of biostatistical methods can improve the design and evaluation of alternative toxicological methods.

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