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Back to the forum  Query: 2017-10-17 02:06 CEST (UTC+2h)
 
sushil.pimpare
Junior

India,
2017-06-06 07:53

Posting: # 17446
Views: 927
 

 Incurred sample reanalysis [Regulatives / Guidelines]

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?
ElMaestro
Hero

Denmark,
2017-06-06 10:20

@ sushil.pimpare
Posting: # 17447
Views: 785
 

 Incurred sample reanalysis

Hi sushil.pimpare,

» 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.

I could be wrong, but…


Best regards,
ElMaestro

- since June 2017 having an affair with the bootstrap.
Ohlbe
Hero

France,
2017-06-06 12:10

@ sushil.pimpare
Posting: # 17450
Views: 770
 

 Incurred sample reanalysis

Dear Sushil,

Please follow the forum policy when posting, particularly under "Be polite".

» 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?

I agree with ElMaestro. Using the ISR result may not be accepted and should only be considered if:
- you have identified a root cause for the deviation. I mean a real root cause, not just something like "the analyst may have made a mistake when processing the sample"
- you can identify all samples affected by this same root cause and re-analyse them. Meaning, not just those already re-analysed for ISR and where you found a large difference.

One example could be a situation where the analyst failed to react on internal standard response deviation. You could go back to the raw data, identify all samples with IS deviation and re-analyse them.

Regards
Ohlbe
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