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RegisterIncurred sample stability [Regulatives / Guidelines]
Dear Members,
In 2013 White Paper on recent issues in bioanalysis: there was a topic of Incurred sample stability (ISS). The same was not discussed in the draft guidance on Bioanalytical Method Validation released in September 2013 by FDA.
Is ISS a regulatory requirement for bioequivalence studies? If yes please guide me how to perform ISS? (Like minimum number of samples required, selection criteria of the samples and acceptance criteria)
Thanks & regards,
Avinash Jain
In 2013 White Paper on recent issues in bioanalysis: there was a topic of Incurred sample stability (ISS). The same was not discussed in the draft guidance on Bioanalytical Method Validation released in September 2013 by FDA.
Is ISS a regulatory requirement for bioequivalence studies? If yes please guide me how to perform ISS? (Like minimum number of samples required, selection criteria of the samples and acceptance criteria)
Thanks & regards,
Avinash Jain
Complete thread:
- Incurred sample stabilityavinash 2014-02-04 05:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Incurred sample stability Ohlbe 2014-02-04 09:17
- Incurred sample stability avinash 2014-02-04 09:44
- Incurred sample stability Ohlbe 2014-02-04 09:17
Ing. Helmut Schütz