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Preclinical Safety Testing

Meaning

Preclinical Safety Testing is the essential, initial phase of research and development for a new therapeutic agent, such as a hormone analog or peptide, conducted before any human trials are initiated. This testing involves comprehensive in vitro (cell culture) and in vivo (animal model) studies to assess the pharmacological activity, toxicity, and pharmacokinetic profile of the compound. The primary objective is to establish a preliminary safety margin and determine the initial safe starting dose for the subsequent first-in-human clinical trials, providing the critical data necessary for an Investigational New Drug (IND) application.