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Dear all ,
Can any body suggest me the BE study design (sample time points) for
Medroxy progesterone acetate
regards,
Viresh
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The following message was posted to: PharmPK
We performed some studies in the 1987 on medroxyprogesterone,
See Stockdale et al, Cancer Treatment Reports 1987, 71, 813-815.
Graham Mould, PhD
Consultant Pharmacist
Direct Tel: +44 (0) 1483 688304
Email: gmould.-at-.gcpl.co.uk
Surrey Technology Centre
Surrey Research Park, Occam Road
Guildford, Surrey GU2 7YG
www.gcpl.co.uk
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The following message was posted to: PharmPK
Hi Viresh!
I don't know which formulation and which dosage you'll employ for the BE
study and the indication of the treatment (hormonal therapy - where low
doses are employed - or palliative/anabolizing treatment where high
doses
are used).
However MPA is characterized from a long half-life (about 30-40 hours
in our
long experience on MPA PK) and could induce its hepatic metabolism.
In addition MPA is scarcerly soluble in water and difference in drug
formulation could induce different PK profile as we observed in the past
with two oral MPA formulation (sachet against oral suspension) after
high
dose administration.
So, I suggest you to follow the PK profile at least until 72-96 hours
after
the administration. We measured drug plasma levels 96 hours after a
single
HD dose.
After oral treatment we measured Cmax about 1-2 hours after the
administration. So you could take samples at time 0, 1, 2, 3, 4, 6, 8,
10,
24, 36, 48, 72 hours (possibly 96 hours).
Then for MPA it's important to evaluate the period influence.
The intersubject variability is also very high (also 60%) and you need a
sufficient number of subjects for the study.
If you want, I can send you our MPA PK data (published and not
published) so
you can have an idea of the problem.
Hope all these informations could be useful.
Best regards
Elena Strocchi
--
Elena Strocchi
Laboratorio di Farmacocinetica e Metabolismo
Dipartimento di Chimica Organica
Universita di Bologna
Viale Risorgimento, 4 - 40136 Bologna
E-mail strocchi.-a-.ms.fci.unibo.it
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Dear Elena / Viresh,
Just an opinion - (a) I just want to add that ideally the samples
should be taken till 3 to 4 half lives (as deemed feasible) .... comes
in handy while extrapolating AUC 0-infinity and documents underlying
basis for making such calculations, even if the authorities like FDA,
etc may have agreed to an early termination at 72 hours. (b) Also for
highly variable drugs, 4 period, replicate design (TRTR or RTRT dosing
pattern) can be taken into consideration. The design and Confidence
interval depends upon the nature of drug - i.e. whether the drug has
high inter or intra subject variability.
I suggest a biostatistician be consulted as well for the timepoints
and study design.
Dr. Gagandeep Singh
Sr. Consultant, Lifesciences - Cognizant Tech Soln
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