Drug Bioequivalence Page: 19
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19
important to detect. The choice of sample size
requires that the probability of failing to detect
important differences be small, when such differences
exist.
METHODS OF ANALYSIS
The experimental results of bioavailability studies
can be analyzed statistically in many different ways.
The statistical methods of analysis depend on (1) the
statistical model of the concentration-time curve,
(2) the statistical model of the various sources of
variation (for example, person-to-person variations,
or nonindependent measurements) , and (3) the
experimental plan that specified how the measure-
ments were to be made.
Perhaps the simplest way to use concentration-time
curves for comparing two drug 'products is not to
compare the entire curves but to compare charac-
teristics of the curves that are deemed important
with regard to the drug product under study--for
example, area under the curves, peak heights, or
rates of absorption. If only a single characteristic
is involved, an appropriate method of analysis is
the method of paired comparisons, in which each
individual generates a paired difference. There
are also adequate statistical procedures for the
comparison of two or more sets of variables, and
these, can be used when more than two drug products
are studied.
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United States. Congress. Office of Technology Assessment. Drug Bioequivalence Study Panel. Drug Bioequivalence, report, July 1974; [Washington D.C.]. (https://digital.library.unt.edu/ark:/67531/metadc39335/m1/23/: accessed April 17, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.