rajasekharkakarla ☆ India, 2019-09-20 08:35 (1652 d 06:08 ago) Posting: # 20628 Views: 1,740 |
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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 |