E-drug: Generic quality (cont)
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Dear Dr. Smith,
In the Philippines, we used to require bioequivalence testing for
generic products that fall under what we call List B which means that
these are drugs that have narrow margin of safety, may pose
bioavailability problems because it is easily affected by factors
like age, food etc and for other similar reasons. Our
regulatory agency created an advisory board to decide on the
accreditation of institutions or agencies that wish to conduct
bioavailability test. However, there is no standard lab that can
validate their results.
This is a problem which I think, developed countries can help us.
When I did my bioequivalence studies for three rifampicin
formulations 2 years ago, I obtained results showing that the 3
formulations were not bioequivalent. I deliberately set aside
aliquots of my blood samples, unfortunately several months passed
with me unable to solicit help to help me validate my results. So I
guess it is for me to simply claim that my results are valid and
reliable and be challenged.
The Department of Pharmacology of UP College of Medicine had
performed several bioequivalence studies dating as far back 15 years
ago.Please be informed that more often than not our generic products
were bioequivalent with the originator drug or the drug dominating
the market. In fact, to our surprise, we
discovered two generic products from two multinationals failing the
test. So it is not true that generics from developed countries always
pass bioavailability test. I have replied to your message because as
the chair of the Department I am looking for agencies, institutions
or anybody who can serve as
our standard or reference lab. I hope you can help us.
Jody Vergeire-Dalmacion,MD
Department of Pharmacology and Toxicology
UP College of Medicine
547 Pedro Gil, Ermita 1000 Manila
Philippines
email:jund45@hotmail.com
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