Deficiencies ?? [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-01-26 11:47 (783 d 14:33 ago) – Posting: # 22190
Views: 2,140

Dear all,

I recently came across a deficiency letter of the Polish agency.
    Clinical documentation

    The applicant is asked to comment on the following questions regarding documentation on bioequivalence.
    Primary pharmacokinetic parameters determined Cmax and AUC(0-t) of ██████ of the test product against the reference product does not meet the assumption on the bioequivalence criteria contained in the guideline CPMP/EWP/QWP/1401/98 Rev. 1/Corr ** and in the Study protocol.
    1. […]
    2. Lack of a posteriori data on the power of statistical inference and at at the same time, lack of detailed criteria for estimating the sample size excludes the possibility of assessing whether the 90% confidence interval in the range of 80 – 125% for log-transformed pharmacokinetic parameters Cmax and AUC(0-t) of ██████ was designated with at least 80% power.
    3. ANOVA analysis of variance showed statistically significant (at a 5% significance level) differences in AUC(0-t) between investigational products, which further exacerbated the uncertainty about fulfillment of the bioequivalence criteria.

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