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RegisterReference replicated designs [Regulatives / Guidelines]
Dear All,
As per FDA guidelines "We recommend that if the predose value is greater than 5 percent of Cmax, you drop the subject from all BE study evaluations".
Is it applicable for fully replicated designs also, if i got greater than 5% Cmax in period 4 whether i need to exclude the subject from entire study or can we use available data for Swr calculations if subject completed two reference treatment periods.
Thanks&Regards,
Rajasekhar
As per FDA guidelines "We recommend that if the predose value is greater than 5 percent of Cmax, you drop the subject from all BE study evaluations".
Is it applicable for fully replicated designs also, if i got greater than 5% Cmax in period 4 whether i need to exclude the subject from entire study or can we use available data for Swr calculations if subject completed two reference treatment periods.
Thanks&Regards,
Rajasekhar
Complete thread:
- Reference replicated designsrajasekharkakarla 2019-09-20 06:35 [Regulatives / Guidelines]
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