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Exposure-Response Modeling
book

Exposure-Response Modeling

by Jixian Wang
July 2015
Intermediate to advanced content levelIntermediate to advanced
351 pages
10h 2m
English
Chapman and Hall/CRC
Content preview from Exposure-Response Modeling
Dose–response relationship, dose determination, and adjustment 271
9.5.4 Dose adjustment for causal effect determination: RCC
trials
Although dose adjustment may introduce bias, it can a lso be used to reduce
or eliminate the bias in exposure–re sponse r elationships, by controlling indi-
vidual patient’s exposure levels. It is often not possible to control individua l
concentrations, however, a partial control can be achieved by randomized con-
centration controlle d (RCC) trials (Sanathanan et al., 1991; FDA, 2003) in
which patients are randomized into two or three exposure ranges and the PK
exposure is measured repeatedly and the dose adjusted, if necessary, until
the individual expo sure level is within the range the patient is randomized
to. Design ...
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Publisher Resources

ISBN: 9781466573215