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Is signature of the subject necessary on dosing label or form in BE studies?

April 26, 2017dosing form Label necessary signature Subject

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Is signature of the subject necessary on dosing label or form in BE studies?

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CHP: No. A BA/BE study is a Phase I (confined) study and the medication is given to the subject by the study staff – usually in a paper ‘medicine cup’ and not in a bottle as one would do on a multiple dose Phase III ambulatory study. In this case, there is no dosing label.