Abstract
During development of any drug candidate, use of more than one laboratory and/or multiple analytical procedures is common. Both situations often warrant a cross validation study, however, presently there is no clear consensus on the best study design for this. Moreover there are varying views on the scenarios for which a cross validation study may be appropriate. Here the term ‘cross validation’ is differentiated from ‘abbreviated validation’, and a study design which accounts for assay variability (inter- and intra-batch) is presented in detail and proposed for application to inter-laboratory and inter-assay comparisons. The procedure uses estimations of inter- and intra-batch variability to calculate the number of replicates and batches necessary for the cross validation analysis of the data using analysis of variance, and a confidence interval approach is discussed.
Published Version
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