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Non-Clinical Studies

Meaning

Non-Clinical Studies are a mandatory set of in vitro (test tube) and in vivo (animal model) investigations conducted prior to human trials to assess the safety profile and biological activity of a new therapeutic agent, such as a hormone or drug candidate. These studies provide critical data on pharmacokinetics (ADME: absorption, distribution, metabolism, excretion) and toxicology, establishing a preliminary therapeutic index and identifying potential target organ toxicities. In the hormonal health space, they are essential for informing the initial safe dosing range and predicting potential human side effects before a compound is administered to a patient population.