Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-08-24 01:05 CEST (UTC+2h)
 
arl_stat
Junior

India,
2017-05-17 08:42

Posting: # 17363
Views: 826
 

 CDISC domains [Regulatives / Guidelines]

Hello Everybody,

Greetings to all!!

This is regarding the new CDISC requirement.

Is there list of domains that are mandatory to submit with this current requirements for BA/BE studies?


Thanks in advance.:-)
DavidManteigas
Regular

Portugal,
2017-05-17 10:28

@ arl_stat
Posting: # 17365
Views: 655
 

 CDISC domains

Hi arl_stat,

I'm not aware of any guidance stating which CDISC domains are "mandatory". From my perspective (and CDISC perspective also), you must submit all data collected under SDTM domains (except those used for operational purposes only, such as check questions). What you may ask, and it will depend on your personal view, is which ADaM datasets are necessary.

Regards,
David
arl_stat
Junior

India,
2017-05-20 08:41

@ DavidManteigas
Posting: # 17375
Views: 514
 

 CDISC domains

Thank You so much:-)
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,243 Posts in 3,687 Threads, 1,056 registered users;
15 users online (0 registered, 15 guests).

I try not to think with my gut.
If I’m serious about understanding the world,
thinking with anything besides my brain, as tempting as that might be,
is likely to get me into trouble.    Carl Sagan

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed