Dear SirBack to the Top
Please let me know what precausions and parameters i should
take under consideration while conducting parallel Bioequivalence
Secondly there is any limit to take the no of subjects in a BE study of
highly variable drug?
I would really appriciate your help.
Thanking you in anticipation.
Department of Bioequivalence and Clinical Research
Almebic Pharmaceuticals Ltd.
Dear YogeshBack to the Top
There are some factors which ultimately together define for which type
of study one should go.... like half life. Usually drugs which are
having longer half life require to be done in parallel way.
Regarding sample size of study, you have to justify for the samples
size taken for the conducting bio-study. There are some studies with
120 volunteers and accepted by regulatory bodies.
Hope this will serve you at some what extent.
Dept. of .Pharmacokinetics,
GLENMARK RESEARCH CENTRE
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