Incurred sample reanalysis [Regulatives / Guidelines]
Hi sushil.pimpare,
After ISR investigation? Perhaps I get your question wrong but I am leaning towards a no. You usually use the original one for PK and stats, unless you have a root cause. The ISR value is typically used for ISR purpose only.
Note also that if you have a root cause it will sometimes -though not always- imply that more samples than just the ones used for ISR need a re-analysis.
❝ After ISR investigation (for the samples those are having % difference more that 50 %), Can we report and consider ISR value for PK and Stat analysis if it is mentioned in the SOP?
After ISR investigation? Perhaps I get your question wrong but I am leaning towards a no. You usually use the original one for PK and stats, unless you have a root cause. The ISR value is typically used for ISR purpose only.
Note also that if you have a root cause it will sometimes -though not always- imply that more samples than just the ones used for ISR need a re-analysis.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Incurred sample reanalysis sushil.pimpare 2017-06-06 07:53 [Regulatives / Guidelines]
- Incurred sample reanalysisElMaestro 2017-06-06 10:20
- Incurred sample reanalysis Ohlbe 2017-06-06 12:10