Toxicity testing of peptide for human use

The extent and design of animal tests to obtain information on the possible risks involved with the use of a new peptide in man is still a matter of dispute. It might be relevant to carry out subacute or prolonged toxocity studies in animals also on peptides of human origin to evaluate the possible risk involved if systematically administered peptides reach distant target organs in much higher concentrations than normally, especially peptides whose biological action is close to the site where they are secreted. It seems possible to handle synthetic analogues of naturally occurring peptides similar to any other synthetic compound concerning toxocity testing in animals. Improved methods of peptide synthesis and of chemico-physical characterization may in the future decrease the problem of differences between batches. Today tests should be carried out on hypotensive effect in cats and perhaps also a subacute toxocity study undertaken in animals on each batch prepared by the solid phase technique.