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

posted by Helmut Homepage – Vienna, Austria, 2019-10-20 15:23  – Posting: # 20710
Views: 4,450

Hi Nastia,

» Dear smart people!

     ^^^^ [image] Are you talking to me?


» should we try to keep as much data as possible for the analysis?

In principle yes – as long as the outcome is meaningful. ;-)

» 1). How would you advice to deal with subjects, who have only one (2,3..) points over LLOQ in one of the periods? […]

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.

» 2). What was the real reason for FDA to develop an algorithm for NTIDs with only complete data?

No idea. The same is applicable to all RSABE-methods of the FDA.

» […] theoretically it is possible to use all the data even with incomplete data.

Sure.

» Why then FDA just throw data of subjects with incomplete data to the bin?

Again – no idea.

» Is not it unethical? (I can't understand this point)

IMHO, it is and we are not alone with this conclusion.*

If SABE is applied, subjects with one missing R observation should be eliminated […]. This is unprecedented in our experience in a regulated bioequivalence setting. Traditionally, one does not exclude data unless there is a scientifically or clinically valid reason to do so. However, with the current draft guidance from FDA for progesterone bioequivalence, this appears to be the immediate approach to be applied for SABE.




Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
20,811 posts in 4,355 threads, 1,448 registered users;
online 22 (1 registered, 21 guests [including 13 identified bots]).
Forum time: 12:08 CEST (Europe/Vienna)

One of the symptoms of an approaching nervous breakdown
is the belief that one’s work is terribly important.    Bertrand Russell

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