Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013.

Drug Des Devel Ther · 2016 · PMC5153257 · PMID 27994442

Europe PMC DOI

hedged sentence

0.4160

closest p · 8.3× alpha

0.4160

boldest claim

The sentences

failed to reach statistical significanceP =0.416not close (p > 0.1)

Safety factor and consequence of MRSD determination method The median safety factor was numerically much lower for the MABEL- or MED-based approach than for the other approaches, although this difference failed to reach statistical significance (10 vs 32.2–53, P =0.416, Table 2 ).

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