In drug development, “proof-of-concept” refers to a part of the clinical study that aims to proof the therapeutic concept.
Synonyms
PoC
Detailed description
The “Proof-of-concept” study takes place at the beginning of the clinical phase when a substance has already demonstrated its efficacy in animal studies and preliminary investigations concerning its safety have been successful. Its purpose is to show whether the substance of interest does actually influence disease-relevant mechanisms.
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