Missing periods in replicate designs: kill the data? [RSABE / ABEL]

posted by Astea – Russia, 2019-10-21 01:59 (346 d 02:19 ago) – Posting: # 20711
Views: 5,327

Dear Helmut and other smart people!

» Are you talking to me?
Hey, you! Yes, you!

» Tricky – IMHO, case by case (should be laid down in an SOP or the SAP, of course). IIRC, Health Canada had a rule that 1 (one!) concentration is sufficient for Cmax and 3 (oh dear!) fo AUC. Gone with the wind. THX, HC.

Suppose we have only one measurable concentration and it is as high as Cmax of other periods. Even in this case formally we can calculate AUC for linear trapezoidal rule (depending on the rule for BLOQ data of course). And it can be more than 5 percent of geometric mean of other AUC in this period. Leave it or waste it - any choice will be wrong :no:

Complete thread:

Activity
 Admin contact
21,090 posts in 4,398 threads, 1,469 registered users;
online 8 (0 registered, 8 guests [including 5 identified bots]).
Forum time: Thursday 04:19 CEST (Europe/Vienna)

In these days, a man who says a thing cannot be done
is quite apt to be interrupted by some idiot doing it.    Elbert Green Hubbard

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5