Mechanism of Action Investigations

Understanding both the on-target and off-target pharmacodynamic effects of a therapeutic can support the proof-of-concept validation of the target and the selection of the development candidate. This preclinical work can establish a biomarker whose modulation can link in vitro studies and preclinical models to early clinical data to support the translational science required for successful drug development. Preclinical models can facilitate mechanism of action studies by providing a system that can be studied more intensively than can be done in clinical studies by enabling, for example, dosing at levels that may not be sustainable in patients or providing diseased and normal tissue that can be extracted and analyzed to better understand the effects of a compound on in vivo systems.

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