Pilot or pivotal ? [General Sta­tis­tics]

posted by Ohlbe – France, 2018-06-27 16:13 (1674 d 20:27 ago) – Posting: # 18978
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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 ?

Regards
Ohlbe

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