ABSTRACT
Approach to the study of processing effects on the potency of platelet concentrates using concurrent paired study designs. See References 59, 60, 61.
concurrent, unpaired study and a one-group paired sequential study, or a one-group paired
concurrent study. The latter study has largely been performed in vitro, and in vivo when double isotope labeling techniques are available, such and Indium and Chromium.(58,61) Paired
sequential studies or two-group concurrent studies can be performed in vitro, or in vivo using single isotopic tests. Assessing the number of studies which needs to be performed is a function
of the degree of difference to be detected (power) at any defined statistical probability level
(Figure 9). Adopting this approach towards an analysis of processing of the various activities
associated with the generation of a final end product will ultimately result in data which could
meaningfully influence the quality of products ultimately transfused (Figure 10).
