3 period full replicate [RSABE / ABEL]

posted by Dr_Dan  – Germany, 2015-06-24 18:43 (3250 d 19:54 ago) – Posting: # 14978
Views: 29,223

Dear Detlew

❝ The full replicate 3-period design has the sequences TRT / RTR as is stated in your post and of course has T and R replicated. Not in each subject, but if balanced in half of ntotal each. And this design of course allows the evaluation of the intra-subject variabilities of T and R separately.


I think the question is whether a replication in only half of ntotal is sufficient in order to scale or ???

❝ So what's the problem of the "leading European regulatory authority"?

❝ Especially in the light of ElMaestro's remark that only the intra-subject variability of R is of any regulatory concern if scaled ABE is aimed for :confused:.


With regard to ElMaestro's reply: in a former statement the "leading European regulatory authority" had no problem with full replicate design (=4 periods and 6 possible sequences) and half replicate designs (3 periods and 3 sequences). A full replicate 3-period design would not work according to their argumentation since a 3 period design implicity needs 3 sequences.
I do not know why. Maybe you have an idea?
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan

Complete thread:

UA Flag
Activity
 Admin contact
23,029 posts in 4,834 threads, 1,641 registered users;
29 visitors (0 registered, 29 guests [including 6 identified bots]).
Forum time: 14:37 CEST (Europe/Vienna)

The most erroneous stories are those we think we know best–
and therefore never scrutinize or question.    Stephen Jay Gould

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