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This question cites a specific drug, but could apply to any other drug.
Hydrochlorothiazide is not currently licensed as a single-drug
formulation in
the United Kingdom. It is, however, licensed in many other countries,
such as
Italy and Canada, and can be obtained in the UK. In a bioequivalence
study,
performed for regulatory purposes in the UK, can a new formulation of
hydrochlorothiazide be compared with a legal importation of a
formulation of
hydrochlorothiazide from another country?
Jeff Aronson
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For purposes of research it is okay as long as the reference
product is of good quality.
However where you plan to register the product in the UK you make
have to check with the British licensing authority for the guidelines.
s.o.o
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Dear Jeff
I think I might ask whether a classic BE study is strictly necessary
for a
regulatory reason because they are done to register a novel
formulation in a
market where a standard has been authorised and the manufacturer has
to show
that the new form meets the pharmacokinetic criteria of the established
product. In your case there is no standard in the UK so logically you
only need to establish that the profile of the new formulation
matches the
published profiles of successful formulations in other countries. If
that
does apply you would only need to assess the one formulation.
Against that however, you could regard using the formulation from
that other
country as a positive control for insurance against an unforeseen
problem
that would apply to both formulations. For example, your population
might
eliminate the drug faster than the one used years ago, so your apparent
bioavailability is that much lower and you would have no way of
explaining
it... A disaster in fact. Other factors such as storage conditions
of your
samples in transit might cause a deterioration of some kind and give
you the
same problem. In that way the relatively small extra cost of the second
doses plus assays might well be worthwhile.
Going back to the strict logic of regulatory requirements, a totally new
compound would have its absolute bioavailability assessed which
requires an
IV-Oral comparison ... and you are back to a two dose study. That
too could
be a logical procedure for you as you would be showing that you have an
acceptable bioavailability that matches those of the foreign
formulations,
and not necessarily the PK profiles themselves, which are more difficult
targets.
I think either study would do the job but I would probably do the
dual oral
formulation study, mainly because it would show that absorption was
acceptable anyway without actually measuring it. On the wider scale you
mention, I can also imagine that other less well known drugs in the same
situation would have to follow the IV-Oral route.
I hope this is helpful..
Andrew
--
Andrew Sutton,
Guildford Clinical Pharmacology Ltd.
The Technology Centre, Occam Road
Guildford, Surrey, UK. GU2 7YG
Tel: +44 (0)1483 455375. Direct: 688303
URL: www.gcpl.co.uk
Registered in England & Wales, No. 2934719
Registered Office: 8 Baker Street, London W1U 3LL
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The following message was posted to: PharmPK
Hi,
Such studies has to be approved by local regulatory
body and should follow their guidelines.
Regards,
Dr.Sridhar
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