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

posted by Helmut Homepage – Vienna, Austria, 2019-10-20 17:23 (1817 d 04:41 ago) – Posting: # 20710
Views: 10,650

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 However, with the current draft guidance from FDA for progesterone bioequivalence, this appears to be the immediate approach to be applied for SABE.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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
23,249 posts in 4,885 threads, 1,652 registered users;
43 visitors (0 registered, 43 guests [including 10 identified bots]).
Forum time: 22:05 CEST (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

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