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Dear All,
Can any one throw some light on the basic difference among Average,
Population and Individual Bioequivalence?
I believe that Average bioequivalence has certain draw backs like it
cannot address the subject-formulation effect. If so, then why we prefer
Average bioequivalence for non-replicate studies and why cant use
Population BE.
Also, is Individual BE preferred for Replicate designs or any other
better alternatives?
Thanks in advance.
Regards
Joseph
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The following message was posted to: PharmPK
Dear Joseph,
ABE is based on population mean comparison however PBE and IBE
employs aggregate criteria that combine information on difference in
bioavailability between formulation mean and difference in
bioavailability variation of formulation between and within subject.
I think for IBE atleast needs a replicate design.Its primary
objective was to introduce to add Subject*formulation Interaction.
A major difference in ABE, PBE and IBE is that in ABE test problem
can easily be translated to the test problem on the original scale,
however PBE & IBE is a function of both location and scale parameters
which can only be defined on ln-scale.
Hope this helps.
Regards,
Vikesh Shrivastav
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