Acute animal tests are not needed
European initiative finds that acute toxicity studies in
animals are not required prior to first - in - human clinical
trails.
In 2003, a European industry working group with
representatives from 13 pharmaceutical companies and 5
contract research organisations was established to assess how
acute toxicity data are used across the pharmaceutical
industry and to provide recommendations for strategies to
replace them. With help from the UK National Centre for the
Replacement, Refinement and Reduction of Animals in Research
and support from the European Federation of Pharmaceutical
Industries and Associations, the group found that acute
toxicity data were not used to terminate drugs from
development, support dose selection for
repeat dose studies in animals or to set doses in the first
clinical trials in humans. (Regul.Toxicol.Pharmacol. 5 Dec
2007; doi:10.1016/j.yrtph.2007.11.009).
Since the working group was set up, most companies have
reduced their use of these tests. Moreover the working group
has been communicating its findings to the wider
pharmaceutical community, particularly with the the
international Conference on harmonisation (ICH), which aims
to eliminate unnecessary test procedures during the research
and development of new medicines. The ICH has incorporated
the group's recommendations into its latest draft guidance on
preclinical test requirements.