Pre-clinical and Clinical Trails

Preclinical development, also known as preclinical studies and nonclinical studies, is a phase of drug development that starts before clinical trials (testing on humans) can start. It is during this phase that crucial feasibility, iterative testing, and drug safety data are gathered.

Determining the safe dose for the first-in-man study and evaluating a product's safety profile are the primary objectives of pre-clinical research. Products could include novel pharmaceuticals, medical devices, gene therapy treatments, and diagnostic equipment.

Only one out of every 5,000 molecules that start drug research and advance to the preclinical stage of development end up being authorized drugs.


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