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Tagged: Proof of Mechanism

The BBCR team designs Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies with the drug clinical plan and regulatory strategy in mind.

December 19th, 2019 | Proof of Mechanism

Proof of Mechanism (PoM) Usually in Healthy Volunteers, Phase 1 study Essential for the selection of appropriate dose for PoC, disease model and biomarkers Investigate drug concentration at the target site of action Investigate drug engagement with target molecular receptor or enzyme (e.g. Receptor binding Investigate if drug biological response after target binding match the […]

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