Dear Pakhi
As per EMEA GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE
Doc. Ref.: CPMP/QWP/EWP/1401/98 Rev. 1
It says as mentioned below
representative number of chromatograms or other raw data should be
provided covering the whole
concentration range for all standard and quality control samples as
well as the specimens analysed.
This should include all chromatograms from at least 20% of the
subjects with QC samples and calibration standards of the runs
including these subjects
regards
shakeel
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shakeel
shakee.salam@yahoo.com
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