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RegisterFDA 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).
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).
Complete thread:
- FDA requirement for Safety data for ANDAs SDTMSriraj 2016-11-25 10:14 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA requirement for Safety data for ANDAs SDTM DavidManteigas 2016-11-26 19:09
- FDA requirement for Safety data for ANDAs SDTM Sriraj 2016-12-01 10:28
- FDA requirement for Safety data for ANDAs SDTM DavidManteigas 2016-12-02 10:22
- FDA requirement for Safety data for ANDAs SDTM Sriraj 2016-12-01 10:28
- FDA requirement for Safety data for ANDAs SDTM DavidManteigas 2016-11-26 19:09
Ing. Helmut Schütz