Pilot or pivotal ? [General Sta­tis­tics]

posted by Ohlbe – France, 2018-06-27 14:13 (819 d 09:40 ago) – Posting: # 18978
Views: 8,120

Dear ElMaestro,

» » OK, maybe if the product has a very low variability and the number of subjects remains very low, it could make sense and save time to directly go for the pivotal. Any experience ?

» Yes absolutely. The majority of dossiers are being accepted without pilot trials.

Sure, when you only have one test formulation. But when you hesitate between two ? Would you directly go for a pivotal where both test formulations would be compared to the reference, and then file whichever one passes ?


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