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The following message was posted to: PharmPK
Dear All,
Is it possible to proof BE for 2 different extended release dosage
forms:
capsules and tablets? I mean are there regulations consider that
situation
or it is impossible due to the fact that there are different dosage
forms
which cannot be compared with each other?
Thanks a lot,
Kamila Chwiloc
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The following message was posted to: PharmPK
Dear Kamila,
Yes is is perfectly possible and is in fact often done when a new
formulation of a drug is under development. Slow release forms tend to
produce greater variances and that demands bigger group sizes (24
minimum)
in your formal Phase 1 BE study. You might also have to consider a
proof of
efficacy equivalence that includes some absorption study samples. For
example when were asked to compare a novel topical spray of an analgesic
with a gel as part of proving efficacy equivalence to the regulatory
authorities we also took several Pk plasma samples. In a more recent
design
we are aiming to look at subcutaneous and knee synovial fluid
concentrations
of an NSAID following a new injection versus a topical gel.
Good luck
Andrew Sutton.
Andrew Sutton, MBBS, MD(London), FFA
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
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