Truncated 72 hours [NCA / SHAM]

posted by mmw – India, 2015-02-09 11:12 (2318 d 21:53 ago) – Posting: # 14389
Views: 7,449

Dear All,

We have conducted a truncated bio-equivalence study (truncation up to 72 hours as per European GL requirements). But it was found that around one-third of the study population did not turn up for 72.00 hours ambulatory sample.

Is their any impact on calculation of AUC due to number of missed sample? Could these subjects be excluded from statistical analysis? If yes, on what basis we exclude these subjects? However, this was not mentioned anywhere in guideline regarding exclusion of such subjects in truncated studies?



Edit: Category changed. [Helmut]

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