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Dear Members,
This is regarding the above mentioned subject, can anybody help me out
in designing the protocol (design, statistical analysis etc.) for
Bioequivalence study based on the urinary excretion data. I am not
able to locate the detailed information/ guidelines on designing the
protocol based on the urine excretion data.
If anybody is having the article or sample study protocol it will be
more helpful to me.
Thanking in advance.
Ratnakar Jadhav
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The following message was posted to: PharmPK
Hi Ratnakar,
I have done a relative bioavailability and food effect study using
urine data many years ago (the study design was that of a
bioequivalence study). The justification for the use of urinary
excretion data was that the plasma concentrations were below the LOQ
of the available method.
The study was then published and here is the reference.
Pharmacodynamics and relative bioavailability of cabergoline tablets
vs solution in healthy volunteers.
Persiani S, Sassolas G, Piscitelli G, Bizollon CA, Poggesi I,
Pianezzola E, Edwards DM, Strolin Benedetti M.
J Pharm Sci. 1994 Oct;83(10):1421-4.
Be aware that you need to be in the same situation (plasma
concentrations below BLQ at most of the times post-dosing) to justify
the conduction of a BE study based on urinary excretion data only. In
my case I also added some PD data to further support BE.
I hope this helps.
Good luck.
Stefano
--
STEFANO PERSIANI, Ph.D.
Director
Translational Sciences and Pharmacokinetics Department
ROTTAPHARM | MADAUS
R&D Division
Rottapharm Spa
Via Valosa di Sopra, 9
20052 Monza - ITALY
stefano.persiani.aaa.rottapharm.com
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The following message was posted to: PharmPK
It would seem that attempts to improve the analytical method should made
before resorting to urine measurements. If the method LLOQ cannot be
improved by concentration, optimizing columns and detection then urine
might
be acceptable. But it would be too chronolgically remote to draw any
rigorous PK or PD associations.
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The following message was posted to: PharmPK
Dear Mr. Ratnakar,
There are quite a few instance where we can measure the drug only in
the urine and we have to prove BE with data obtained from urine. The
protocol can be prepared just like a routine BE protocol with urine
collection procedures and the Parameters to be measured (such as Aet
and Ae inf), which is available in guidelines such as EMEA or FDA.
You can make use of the following Guidelines given by FDA for a
similar BE study with Urine,
Guidance for Industry Potassium Chloride Modified-Release Tablets and
Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing
Regards
Joseph
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