Laura Carreiras
☆    

Portugal,
2022-05-11 13:11
(15 d 06:40 ago)

Posting: # 22969
Views: 222
 

 Effect group in full replicate Bioequivalence [Study Per­for­mance]

Dears,

In a in a bioequivalence study with a full replicate design conducted in more than one group, how shall the group participants be separated/divided?

For example,

Initially we have 3 groups but because of some constraints the washouts for a few participants had to be extended.

The participants will be added to the groups accordingly with the administration date of the first period (even if the other periods can have a different administration date) or the groups shall be formed accordingly with the date of administration of all the periods (for each group all the administration date of the 4 periods has to be the same)?


I hope I was clear.

Thank you for the help.


Edit: Category changed; see also this post #1[Helmut]
dshah
★    

India/United Kingdom,
2022-05-12 11:46
(14 d 08:04 ago)

@ Laura Carreiras
Posting: # 22973
Views: 171
 

 Effect group in full replicate Bioequivalence

Hello Laura!
Generally fully replicate study will be useful for HVD or NTI. In both the condition, the Swt and Swr will play a role in BE acceptance (Particularly AUC). Assuming this- it is better to group according to date of administration of all periods.
Regards,
Divyen
mittyri
★★  

Russia,
2022-05-14 22:30
(11 d 21:21 ago)

@ Laura Carreiras
Posting: # 22988
Views: 136
 

 Effect group in full replicate Bioequivalence

Dear Laura,

» The participants will be added to the groups accordingly with the administration date of the first period (even if the other periods can have a different administration date) or the groups shall be formed accordingly with the date of administration of all the periods (for each group all the administration date of the 4 periods has to be the same)?

I would use the groups with equal administration dates, so the periods are equal within the groups. It won't hurt (CIs won't significantly change) and does not raise the questions since you are following some internal logical rules (different period dates -> different groups).

Kind regards,
Mittyri
UA Flag
Activity
 Admin contact
22,105 posts in 4,630 threads, 1,566 registered users;
online 10 (0 registered, 10 guests [including 1 identified bots]).
Forum time: Thursday 19:51 CEST (Europe/Vienna)

Operational hectic replaces
intellectual calms.    Alexander Huiskes

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