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Dear All,
Please suggest, for Reference scaled BE study, If any subject completed one test and one reference
can be considered for statistical analysis?
Regards
Narayana Kumar
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Dear Mr Narayanakumar,
Usually, in reference scaled BE study, subjects who completed all the periods of the study will be
taken for statistical analysis.
Regards,
Dr S Gunasakaran MD,
Head - Clinical Research & Medical Affairs,
Azidus Laboratories Ltd,
Chennai.
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FDA provided guidance for RSBE. You have to use two reference in your design (TRR, RTR). This has to
be approved by FDA. RSBE is for CV>30%.
Hope it helps.
Kam Zhang
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Dear Narayana,
In SABE BE study, the subjects who completed one test and one reference treatments could be used for
average BE analysis of pk parameters (cmax and
/ auc), if the reference variability less than 30%.
The subjects who completed all the periods ( one test and two reference treatments) will be
considered for scalling BE, if reference variability of any pk parameter is greater than 30% (i.e.
reference variability greater than 0.294).
Regards
Chandra
chandra sekhar
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Dear Mr. Narayanakumar,
Yes. You can consider the subject for bioequivalence analysis.
Regards,
Venkatesan
Team Lead - Statistics
venkatesan Mudaliar
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Dear Kumar
Cant be considered for RSAB
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Dear All,
Please suggest, for Reference scaled (four period fully replicate) BE study, Can we consider any
subject who have completed only three period with one test and two references for PK and stat
calculation.
Please provide reference.
Regards
Narayana Kumar
Narayanakumar R
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