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Hi rajasekhar,
This is where you need an SOP and not a guideline.
Wit three values above the LLOQ the profile for that subject's data is rubbish but in the absence of an SOP you may need to include it still. Perhaps the EMA's Cmax:LLOQ requirement comes to some degree of rescue.
❝ Is there any regulation for minimum measurable concentrations to perform statistical analysis. please let me know is there any supportive guidelines for same.
This is where you need an SOP and not a guideline.
Wit three values above the LLOQ the profile for that subject's data is rubbish but in the absence of an SOP you may need to include it still. Perhaps the EMA's Cmax:LLOQ requirement comes to some degree of rescue.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- statistical evaluations rajasekhar 2017-02-18 11:36 [Regulatives / Guidelines]
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- statistical evaluationsElMaestro 2017-02-18 12:44
- statistical evaluations Ohlbe 2017-02-20 11:59
- statistical evaluations nobody 2017-02-20 14:35
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