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The following message was posted to: PharmPK
Hello Everyone,
I have a very basic question: What is the appropriate statistical
method
to establish dose proportionality? We had three dose level groups
(A, B,
C) in our study, our statistics only conducted bioequivalent test for
dose-justified Cmax and AUCs between each two (B vs. A, C vs A, and C
vs.
B) of the dose groups. The results are hard to explain, for some
criteria, bioequivalency was established between two comparisons (such
as
B vs. A, C vs. B), but not the third one (C vs. A). I understand that
the
bioequivalent test may be more strict, and provide more detailed
information. However, I believe there is a more simple statistic test
which can include all three dose levels in one comparison. Could any
one please give me some help for the appropriate method to establish
dose
proportionality? Any past experience or guidance document will be
highly
appreciated.
Thank you for your attention.
Weijiang
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The following message was posted to: PharmPK
A good acceptable method is that of Smith et al Pharm Res. 17: 1278
(2000)
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The following message was posted to: PharmPK
Dear Weijang:
A detailed report on how to assess dose proportionality was outlined in
"Assessment of Dose Proportionality: Report from The Statisticians in
the
Pharmaceutical Industry/PK UK Joint Working party" Kevin Gough et al.
Drug
Information Journal 1995 29(3), p 1039-48. In my opinion this article
gives
a road map in establishing dose proportionality.
Let me know if you need a copy of the article.
Good luck,
Prasad
Prasad NV Tata, M.Pharm., Ph.D., FCP
Manager-Pharmacokinetics
Mallinckrodt, Inc.
675 McDonnell Blvd.
Saint Louis, MO 63134
Tel: (314) 654-5325
Fax: (314) 654-9325
e-mail: prasad.tata.-a-.tycohealthcare.com
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