These recommendations provide a clear guide for the minimum clinical pathology that
should be included in a toxicology safety evaluation study. Clinical pathology
requirements in toxicity guidelines cannot be considered in isolation but must form part
of a coherent approach to the testing strategy. The need for a certain degree of flexibility
and judgement in what should be measured, over and above the stated minimum
recommendations, is clearly of paramount importance in this approach. Strict adherence
to a list of prescribed measurements, some of which are either not applicable or
completely irrelevant, benefits neither those who provide the data nor those who receive
the data. Both the OECD Shadow Toxicology Group and the IHCPT Committee hope
that their recommendations will serve as the basis for international harmonization of
clinical pathology testing guidelines developed by various government regulatory
agencies and professional standards organizations. For the toxicologist or study director
developing a study protocol for the safety assessment of a new compound they provide
clear guidance of which tests should always be included.