<OFCAC856B2.D90C4F07-ONC1256F00.002397C9-C1256F00.00250115@UNICEF.ORG>
Sender: owner-e-drug@usa.healthnet.org
Precedence: bulk
E-drug: Re: WHO prequalification withdrawals and bio-tests
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[Thanks Murtaday, I did not have time to elaborate. I agree with you.
KM]
KM comments, correctly, that "Not all regulatory authorities require
bioequivalence for all generic products, only for certain products with
small therapeutic window", but Fransisco also asks "So, Bioequivalence
is not a quality test?". As connecting the two issues could possibly be
also confusing and misinterpreted, I thought I could add what is
hopefully not anymore confusing, by responding to Fransico's question
through my opinion that "to the extent that bioequivalence is a
determinant of whether or not a product, when used correctly, performs
according to predetermined standards, to the same extent, it is clearly
a quality problem"
Murtada M. Sesay
Technical Officer (Pharmaceuticals)
UNICEF Supply Division
UNICEF Plads, Freeport
DK-2100
Denmark
Telephone: +45 3527 3098
Facsimile: +45 3526 9421
E-mail: msesay@unicef.org
For every child
Health, Education, Equality, Protection
ADVANCE HUMANITY
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