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by epistasis
1052 days ago
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Phase 1: basic safety, some amount of dose-finding. Small number of patients. Phase 2: does it appear to work as intended, tested in a larger number of people Phase 3: is it better than alternatives. Then approval, followed by monitoring of the drug and side effects. There's also an additional phase of getting insurance to pay for the new drug, which can be the most difficult. https://www.cancer.org/cancer/managing-cancer/making-treatme... |
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Phase 1 is pretty big on safety: sentinel dosing, then gradually increasing doses until the established max is reached or until serious side effects show up. Generally also includes PK/PD aspects: what is the half-life, how long it’s detectable in the body, does this match the modeling? How is the drug eliminated? All this is used to refine the dosing (if need be) but also provides a lot of the information needed for the safety documentation.