Preclinical Testing

Synonyms

Preclinical drug safety evaluation; Preclinical safety testing; Toxicity testing

Definition

The process of testing potential new therapies in animal and cell-based test systems prior to their study in patients in order to assure their potential safety and efficacy.

Characteristics

It was recognized many years ago that potential medicines were often “poisons” so that some form of screening in animal models was required before new drugs could be tried in patients. For all types of medicines, it has been generally agreed that these tests should take the form of both pharmacological and toxicological studies in animals to avoid patients being exposed to drugs that are excessively toxic or without evidence of potential efficacy. Added impetus has come from the Nuremberg Code that was formulated after the trials of the Nazi doctors convicted for the conduct of horrific medical experiments on prisoners. While this code deals primarily with the consent of volunteers and patients, one...