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RegisterDBE tables for FDA submission [Regulatives / Guidelines]
Dear Members,
My question with regard to DBE tables for FDA submission studies.
Under Table 9 “Reanalysis of Study Samples”
Two sections are there
1) Number of samples reanalyzed
2) Number of recalculated values used after reanalysis
Can any one please explain me what is the difference between these two sections?
Thanks & regards,
Avinash Jain
My question with regard to DBE tables for FDA submission studies.
Under Table 9 “Reanalysis of Study Samples”
Two sections are there
1) Number of samples reanalyzed
2) Number of recalculated values used after reanalysis
Can any one please explain me what is the difference between these two sections?
Thanks & regards,
Avinash Jain
Complete thread:
- DBE tables for FDA submissionavinash 2014-01-27 11:59
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- DBE tables for FDA submission drgunasakaran1 2014-01-27 18:39
- DBE tables for FDA submission avinash 2014-01-28 04:47
- DBE tables for FDA submission drgunasakaran1 2014-01-27 18:39
Ing. Helmut Schütz