February 2007
Beginner to intermediate
464 pages
16h
English
book
Pharmaceutical Statistics Using SAS
by Ph. D. Alex Dmitrienko, Ph. D. Christy Chuang-Stein, Sr. Ralph B. D'Agostino
Content preview from Pharmaceutical Statistics Using SAS
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4.7. Limits of Quantification and Range of the Assay
The upper and lower limits of quantitation (ULOQ and LLOQ) of an analytical procedure are the lowest and highest amounts of the targeted substance in the sample that can be quantitatively determined under the prescribed experimental conditions. As a consequence, the range of an analytical procedure is the range between the lower and upper limits of quantitation for which the analytical procedure was demonstrated to have a suitable level of measurement error.
In practice, the information needed to establish the limits of quantitation and the associated range is already available in the measurement profile plot. As proposed by Hubert et al. (1999) and Hubert et al. (2004), the limits of quantitation ...
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