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We are going to conduct clinical study of three strengths of the
drug. During PK and Statistical analysis, we would like to calculate
Can somebody throw a light on this point?
Thanks in advance.
Thanks with Regards,
Veeda Clinical Research Pvt. Ltd.
Shivalik Plaza - A
Near IIM, Ambavadi
Ahmedabad 380015, India
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The following message was posted to: PharmPK
Dear Prakesh (and responders to questionnaire),
A questionnaire on methods used to assess dose proportionality was
posted on the PharmPK website. The questionnaire asked whether dose
normalisation or power model (Gough et al. Drug Information Journal
29:1039 1048) was used and whether beta (derived from power moel) was
estimated with confidence intervals. In addition, if a power model
under what circumstances dose proportionality was concluded; i.e.
one, CI includes unity or within prescribed limits based on Smith's
criterion (Smith: In Pharmacokinetics in Drug Development: Clinical
Design and Analysis, Volume 1, Bonate P., Howard D eds., 363-382. AAPS
Press, USA, 2004).
Of the 11 responders (6 pharmaceutical companies, 3 CROs and 2
consultants), 9 estimated an exponent from the power model with
intervals. Of these 9 responders, 5 claimed dose proportionality if the
exponent included unity, 3 have used the approach recommended by
Smith and 1
concluded dose proportionality if the exponent was close to unity.
Thus, testing of the hypothesis that beta=1 was the most common
however, this was not proposed by Gough et al., and Senn [Statistical
in drug development. Wiley: Chichester, 1997; pp 291 313] emphasised
"it will presumably not be adequate simply to test the null
\0x03B2 is equal to one".
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