The study and the characterization of the pharmacological activity of drug candidates of animals is often hampered by its late highlighting of a toxicity. This toxicity can be linked to the primary and secondary activity of the compound, the product of degradation, but also at its preparation. Our experience highlights that the quality of the drug candidate (composed of a synthesis or a purified extract) and other preparation are very variable and put often problems during the development of new therapies.
We recommend a fast evaluation of the preclinical safety of the pharmacological products which are in development in order to save time and money. The following steps can consequently identify unwanted effects linked to the administration of pharmacological products, which can be used in expensive animal models.
To prevent problems, the safety of the pharmacological products is evaluated with a pharmacokinetic study which needs to adapt to the specific animals. The evaluation made by a unique administration can show a sharp intoxication, while a repeated administration on multiple day can bring to light the poisoning and alteration of the biological functions. The amount of safety verification of a pharmacological product consists the most to determine the maximal dose tolerated by its preparation.