PharmPK Discussion - Steady State Cmax

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• On 24 Jul 2006 at 15:20:59, "sukhbir singh" (sukhbir83.at.gmail.com) sent the message

Dear Participents
I performed a study in which a tablet is given after every 12 hr
interval.Analysis of data showes that Cmax by 2nd dose is less than
first dose which should idealy be otherwise.Could you please suggest
me to what factors I can assign this problem and how to justify this.
With regards
Sukhbir Singh
Statistical Analyst

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• On 27 Jul 2006 at 13:50:29, David Bourne (david.-a-.boomer.org) sent the message

The following message was posted to: PharmPK

Dear Dr. Singh,
Could you please provide your sample size, type of patients, fed/
fasting conditions, and the average +/- SD and median [range] of your
Cmax and Tmax values after the 1st, 2nd etc. dose. This might help to
interpret, if what you are observing is a systematic trend or just
large variability in the oral absorption of your drug.
Best regards
Juergen

--
Juergen Bulitta, MSc
Pharmacometrician, IBMP - Institute for Biomedical and Pharmaceutical
Research
Paul-Ehrlich-Str. 19, D-90562 Nurnberg-Heroldsberg, Germany

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• On 31 Jul 2006 at 18:15:41, David Bourne (david.-at-.boomer.org) sent the message

The following message was posted to: PharmPK

Hi Sukhbir,

You wrote: "Cmax by 2nd dose is less than first dose which should idealy
be otherwise". Could you provide some more information? I am interested
to know how the Cmax values looked liked further down the dosing
interval, e.g. after the 8th or 10th dosing. Also, what do you mean by
less? Are we talking about a small difference in the mean Cmax values or
is it that all individual Cmax values are (significantly) less at 12h
compared to the first dose?

Toufigh Gordi

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• On 31 Jul 2006 at 18:15:56, David Bourne (david.at.boomer.org) sent the message

The following message was posted to: PharmPK

Hi Sukhbir,

You wrote: "Cmax by 2nd dose is less than first dose which should idealy
be otherwise". Could you provide some more information? I am interested
to know how the Cmax values looked liked further down the dosing
interval, e.g. after the 8th or 10th dosing. Also, what do you mean by
less? Are we talking about a small difference in the mean Cmax values or
is it that all individual Cmax values are (significantly) less at 12h
compared to the first dose?

Toufigh Gordi

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