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

posted by Astea – Russia, 2019-10-20 23:59 (648 d 00:30 ago) – Posting: # 20711
Views: 6,623

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
21,592 posts in 4,514 threads, 1,532 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Friday 00:29 UTC (Europe/Vienna)

It is a capital mistake to theorise before one has data.    Arthur Conan Doyle

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