Reference replicated designs [Regulatives / Guidelines]

posted by rajasekharkakarla – India, 2019-09-20 06:35  – Posting: # 20628
Views: 341

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

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