The sample size for the BE is directly poportional with power. However, the proposed/accepted power ingeneral is 80-90%. Consideration of power more than 90 % may end up the issue of ' 'Forced Bioequivalence' by regulatory.
Can any one please explain clearly the term 'Forced Bioequivalence' associated with larger larger sample size due to high power consideration?
http://forum.bebac.at/mix_entry.php?id=6596
Hope this will help you
Dear Srimanta,
look at the following links:
http://www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm304305.pdf
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070111.pdf
http://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/ucm052363.pdf
http://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/ucm052363.pdf
http://www.fda.gov/ohrms/dockets/ac/04/briefing/4034b1_07_bioequivalence%20requirments-draft.htm
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070246.pdf
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm377465.pdf
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm072872.pdf
http://www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm292669.pdf
I hope they will be helpful
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