Guidance on dose level selection for regulatory general toxicology studies for pharmaceuticals

A key objective of this 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 application of the 3Rs. This is achieved by a series of recommendations that are considered good practice by the group. Designed to aid the reduction and refinement of 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.

Published in 2009. The document can be downloaded here.