OnCo
termsTerm

Preclinical

aka pre-clinical, preclinical studies, preclinical study, preclinical data, preclinical evidence, preclinical models, preclinical model, preclinical development, preclinical stage, discovery stage, early research, bench to bedside, translational, translational research, IND-enabling, proof of concept, proof-of-concept, mechanistic studies

Everything done to a potential drug before it is given to a human: lab experiments, animal testing, and the safety and manufacturing work regulators require. Most candidates never make it out.

Preclinical development establishes that a drug hits its target, kills or slows tumours in cells and animals, can be made consistently, and is safe enough at the planned dose to test in people; toxicology in two species is normally required before the first human trial. 'Preclinical evidence' on this site means a claim supported only by such work, and the reader should discount it heavily: roughly 90% of drugs that enter human testing fail, and preclinical findings often do not reproduce even in other labs. Better models (organoids, humanised mice, patient-derived xenografts) and more rigorous reporting are attempts to shrink the gap between bench and bedside.

Category
Biology basics

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