E-DRUG: RFI: Bioequivalence and generics registration (10)
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Hi Anonymous
I am joining this discussion a little late. I hope not to repeat what others
have said.
I also work in a developing country and can offer some practical advice..the
first is very simple..please use your tehnical knowledge as a pharmacist to
determine what is the best solution for each individual drug. As you have
rightly pointed out, the pharmacokinetics and dynamics of each drug molecule
and formulation will determine the nature of the quality assessment
required.
Secondly, from my experience again, I do not think the cost of doing B.E
studies would greatly increase drug prices...may be slightly, in which case,
it is better to pay a little more for a guarantee of quality than spend more
money treating people for "treatment failure"
Thirdly, again as you mentioned, some of the very cheap drugs are the ones
which are problematic...diazepam injection, prednisolone tablets,
griseofulvin tablets- it is up to you to determine the level of quality that
is acceptable and cost effective for the country . Definately, surrogate
indicators like GMP, WHO certification come to mind
Finally, the proof of the pudding is in the eating...it is therefore
important to have postmarketing surveillance or at least keep in touch with
the medical professionals who prescribe/dispense these drugs as this
feedback will inform the future direction of individual drug registration
protocols.
Atieno Ojoo
pharmacist
Kenya
atisojoo@yahoo.co.uk
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