PharmPK Discussion - CV%rez greater than 30%

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On 14 Jan 2005 at 11:54:49, "Jana Zigova" (zigova.at.vulm.sk) sent the message


Dear Colleagues,

does anyone of you have a link to publication where power curves for
sample size calc. in BE studies are published for CV%rez greater than 30%,
let's say for CV%rez = 40%?

Many thanks,

Jana Zigova,
VULM a.s. Modra, Slovakia

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On 14 Jan 2005 at 11:57:58, Navdeep Randhawa (Navdeep.Randhawa.at.biovail.com) sent the message


Hi Jana,

Although, I don't know of a reference that gives power curves for CV >
30% per say, below is a reference where they give sample sizes for CV >
30% (in table format) based on 90% power. They also give formulas that
allow you to calculate sample sizes based on desired power and CV%.
Depending on what you need this for, this may be a helpful reference.

Julious, S.A. Tutorial in Biostatistics - Sample sizes for clinical
trials with Normal data. Statistics in Medicine 2004; 23: 1921-1986.

Regards,
Nav

Navdeep Randhawa
Biostatistician, Pharmacokinetics and Statistics
Biovail Contract Research
Tel: (416) 752-3636

  Email: navdeep.randhawa.aaa.biovail.com
URL: www.biovail-cro.com

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