Deficiencies 🇵🇱 [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-01-26 09:47 (82 d 19:46 ago) – Posting: # 22190
Views: 706

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.

Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 24 (0 registered, 24 guests [including 4 identified bots]).
Forum time: Monday 05:33 UTC (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz