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Challenging the requirement for acute toxicity studies – workshop report published

As part of a collaboration between the NC3Rs and the European pharmaceutical industry a working group of 15 international companies have been sharing and analysing the value of data from single dose rodent acute toxicity studies. The conclusion from this extensive review is that the information obtained from conventional acute toxicity studies is of little or no value in the pharmaceutical development process.

This scientifically driven approach has led to a challenge of the regulatory requirement for acute toxicity studies prior to first-in-man studies. To support discussions on the regulatory requirement for acute toxicity testing the NC3Rs held a workshop in London in November 2006 where the working group presented its findings to regulators from Japan, Europe and the US. Discussion at the workshop indicated that the recommendations of the working group are likely to be reflected in the new draft ICHM3 guidance. The work and the objectives of the group have the support of both EFPIA and PhRMA.

A report of the workshop is now available and it concludes that toxicity data are:

Extremely limited, concentrating on minimum lethal and maximum non-lethal doses.
Of less use than other, less harmful, animal tests that are superior for deciding appropriate doses for further animal studies.
Not particularly useful for information on the nature of toxic effects, which are better evaluated in other routine studies.
Not, in practice, used to set doses in the first human clinical trials because other routine studies provide more informative data.

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