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RegisterNew FDA CDISC requirements for ANDAs [Regulatives / Guidelines]
Hi lechia,
Please, take a look at the Study data technical conformance guide. It is quite clear on what and how you should submit.
http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf
ADaM datasets are necessary for the analysis of the primary objective (Bioequivalence) so at least ADSL and ADPP should be submitted imo. It is up to you to decide wheter you need additonal ADaM datasets, just keep in mind that ADaM datasets purpose is to facilitate the review in case of SDTM domains require a lot of programing to generate the output of the primary objectives (tranpose, etc). If the ADaM dataset is just a "copy" of the SDTM domain with less variables and different variable names, I would use SDTM instead.
Please, take a look at the Study data technical conformance guide. It is quite clear on what and how you should submit.
http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf
ADaM datasets are necessary for the analysis of the primary objective (Bioequivalence) so at least ADSL and ADPP should be submitted imo. It is up to you to decide wheter you need additonal ADaM datasets, just keep in mind that ADaM datasets purpose is to facilitate the review in case of SDTM domains require a lot of programing to generate the output of the primary objectives (tranpose, etc). If the ADaM dataset is just a "copy" of the SDTM domain with less variables and different variable names, I would use SDTM instead.
Complete thread:
- New FDA CDISC requirements for ANDAs lechia 2016-09-19 21:37
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- New FDA CDISC requirements for ANDAsDavidManteigas 2016-09-22 10:47
- New FDA CDISC requirements for ANDAs lechia 2016-11-22 22:33
- New FDA CDISC requirements for ANDAsDavidManteigas 2016-09-22 10:47
Ing. Helmut Schütz