Carry-over [General Sta­tis­tics]

posted by dshah  – India/United Kingdom, 2023-10-03 18:34 (149 d 05:03 ago) – Posting: # 23734
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Dear Achivewin!

❝ Good point...... but CRLs won't leave you without these questions.... somehow regulators seems to be obsessed with that borderline "Carry-over"

How many % of subjects had carryover? If its more than 5% of Cmax, generally the exclusion criteria cover it so that subject is not considered for statistical evaluation. If more than 20% subject has carry over effect (more than 5%Cmax value), than an investigation would be needed but this indicates that washout period was insufficient.

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