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RegisterPilot or pivotal ? [General Statistics]
Dear ElMaestro,
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 ?
❝ ❝ 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
Regards
Ohlbe
Complete thread:
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- Any of two tests and one reference libaiyi 2018-06-27 08:25
- Hey wait a moment.... ElMaestro 2018-06-27 08:29
- Hey wait a moment.... Helmut 2018-06-27 11:45
- Pilot or pivotal ? Ohlbe 2018-06-27 12:14
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- Hey, hey wait another moment.... d_labes 2018-06-28 19:48
- Hey, hey wait another moment.... Helmut 2018-07-03 17:22
- Old belives die hard d_labes 2018-07-04 13:28
- Hey, hey wait another moment.... Helmut 2018-07-03 17:22
- Pilot or pivotal ? Ohlbe 2018-06-27 12:14
- Hey wait a moment.... Helmut 2018-06-27 11:45
- Any of two tests and one reference Helmut 2018-06-27 00:33
- Two tests and one reference Helmut 2018-06-26 13:13
Ing. Helmut Schütz