E-drug: Bio-Equivalence
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Dear Colleagues!
I am interested to know if there are any pre-requisites of
Bio-Equivalence Studies by various Drug Control/Regulatory agencies
like USFDA, Canadian FDA, MCA UK and other similar agencies.
What are the specific generics or groups which require such a
pre-requisite of Bio-Equivalence studies before being considered for
granting registration/permission to market?
Are there any WHO guidelines available on the subject?
Naziruddin Ahsan
Secretary
Pharmacy Council of Pakistan
Islamabad, Pakistan.
ahsan@pharmacy.isb.sdnpk.org
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