Sriraj
☆    

India,
2016-11-25 11:14
(2681 d 02:28 ago)

Posting: # 16812
Views: 4,723
 

 FDA requirement for Safety data for ANDAs SDTM [Regulatives / Guidelines]

Dear Member,

May I know whether for generic drugs BA/BE studies submission do we to report the safety data in SDTM/ADaM standards. Generally only the PK data would be reported and safety observations are discussed in the report. Do we need to collect safety in CDISC standards and submit SDTM datasets, do we need to have Table, listings, Graphs to be provided to FDA for generic drug BA/Be submissions. Or is it ok to provide PK data like pc/adpc pp/adpp and provide a safety report based on CRF pages collected data.

Thank you,
SriKanTH (SriRaj).
DavidManteigas
★    

Portugal,
2016-11-26 20:09
(2679 d 17:33 ago)

@ Sriraj
Posting: # 16815
Views: 4,038
 

 FDA requirement for Safety data for ANDAs SDTM

Hi Sriraj,

Not surte if I understood your question.

According to FDA guidance, all data collected should be submitted, either safety, efficacy or other. Maybe you're talking about the datasets for the module 2.7. Not sure if, under the new requirements for data submission for ANDAs, those datasets should be submitted anyway. I would submit them anyway.

Regards,
David
Sriraj
☆    

India,
2016-12-01 11:28
(2675 d 02:13 ago)

(edited by Ohlbe on 2016-12-01 14:53)
@ DavidManteigas
Posting: # 16819
Views: 3,860
 

 FDA requirement for Safety data for ANDAs SDTM

Dear David,

Thank you for the reply. Sorry for not being clear, the question was w.r.t datasets and TLF submission for Safety in CDSISC standards for generic BA/BE studies submission. Do we need SDTM, ADaMs and TLF for Safety, or is it ok to provide the safety data/report based on CRF data. And provide the PK data in CDSISC standards.

Regards,
SriKanTH (SriRaj).


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]
DavidManteigas
★    

Portugal,
2016-12-02 11:22
(2674 d 02:19 ago)

@ Sriraj
Posting: # 16824
Views: 3,808
 

 FDA requirement for Safety data for ANDAs SDTM

Hi SriRaj,

The purpose of SDTM is to report all the data collected in the study in standard format. So imo you should submit all data of the study, regardless of being related to pk, safety or other (in my experience, we usually submit all the data collected in SDTM format even though much of them is listed in the appendices of the CSR). If you build TFLs based on SDTM transformed data, it should not be hard for you to provide the necessary datasets according to requirements. SDTM and ADaM are standards that allows operational efficiency, both for reviewers and manufacturers. Using them shouldn't be imposed by the FDA but embraced by manufacturers.

Regarding ADaM, unlike SDTM it is more open to interpretations. At least ADSL and ADPP should be created. Whether datasets for safety should also be created, I believe it is a matter of personal choice, since in BABE you don't work that much on safety data to be interesting to have ADAE and other safety datasets built.

Regards,
David
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