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The following message was posted to: PharmPK
We wanted to know that if potency difference between test and
reference product is exactly 5%, then is it acceptable as Bio-batch.
The study is for WHO submission.
According to me, it should be OK, since guidelines mentions that
"difference should preferably not more than +/-5%". However, I would
like to know your views.
Dr. Ashish Mungantiwar
Macleods Pharmaceuticals Limited,
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