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

posted by Astea – Russia, 2019-10-21 01:59 (453 d 15:53 ago) – Posting: # 20711
Views: 5,713

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
21,303 posts in 4,441 threads, 1,487 registered users;
online 5 (0 registered, 5 guests [including 5 identified bots]).
Forum time: Saturday 16:53 CET (Europe/Vienna)

If you can’t solve a problem, then there is an easier problem
you can solve: find it.    George Pólya

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