Guidance on dose level selection for regulatory general toxicology studies for pharmaceuticals
Robinson S, Chapman K, Hudson S, Sparrow S, Spencer-Briggs D, Danks A, Hill R, Everett D, Mulier B, Old S, Bruce C


A key objective of the NC3Rs/LASA collaboration is to provide practical guidance for Study Directors and other toxicologists working in the field of regulatory toxicology. This document is aimed specifically at scientists that are new to, or training in, the role of Study Director. Drawing on the knowledge and experience of the working group members, the guidance document is intended to supplement the process of training and mentoring of Study Directors to improve the scientific outcome of regulatory general toxicology studies and to promote the the 3Rs. This is achieved by a series of recommendations that are considered good practice by the group. The guidance provided in this document has the potential to make substantial progress in reducing and refining animal use in this area, through avoiding unnecessary exposure of animals to marked adverse effects thereby reducing inadvertent morbidity and mortality and avoiding potential repetition of toxicology studies.
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