Best Design of BE Studies (7) - BEBAC ⢠Consultancy Services for ...
Best Design of BE Studies (7) - BEBAC ⢠Consultancy Services for ...
Best Design of BE Studies (7) - BEBAC ⢠Consultancy Services for ...
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7/7 | Statistical <strong>Design</strong> and Analysis IIII<br />
Dose Proportionality<br />
in<strong>for</strong>ma<br />
life sciences<br />
Dose proportionality may be evaluated in a twostep<br />
procedure<br />
(Chow and Liu, <strong>Design</strong> and Analysis <strong>of</strong> Bioavailability and Bioequivalence<br />
<strong>Studies</strong>, Marcel Dekker, New York, pp 563–573 (3 rd ed 2009)<br />
Let Y be the response (AUC, C max ) and x the dose<br />
level. Since the standard deviation <strong>of</strong> Y increases<br />
with the dose, the primary assumption <strong>of</strong> dose proportionality<br />
is that the standard deviation <strong>of</strong> Y is proportional<br />
to x; that is,<br />
Var(Y) = x²σ²,<br />
where σ² consists <strong>of</strong> inter- and intrasubject<br />
variabilities.<br />
Bioequivalence and Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 2 • 19
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