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doi:10.1210/endo.142.12.8522 Ng FM, Sun J, Sharma L, Libinaka R, Jiang WJ, Gianello R

This guidance clarifies the need for developers to explicitly define context of use and demonstrate that a NAM is biologically relevant, technically robust, and fitforpurpose to support regulatory decisionmaking within that context

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Once things calm down, you can usually restart at the same or a lower dose