sushil.pimpare ☆ India, 2017-06-06 09:53 (2508 d 18:43 ago) Posting: # 17446 Views: 4,323 |
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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 ★★★ Denmark, 2017-06-06 12:20 (2508 d 16:16 ago) @ sushil.pimpare Posting: # 17447 Views: 3,809 |
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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. — Pass or fail! ElMaestro |
Ohlbe ★★★ France, 2017-06-06 14:10 (2508 d 14:26 ago) @ sushil.pimpare Posting: # 17450 Views: 3,802 |
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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 |