Change in curve changed the ratio of Cmax [Bioanalytics]

posted by Dr_Dan  – Germany, 2015-03-24 09:15 (3715 d 19:46 ago) – Posting: # 14604
Views: 12,258

Dear Compliance

❝ Please note that the difference between the concentration obtain during initial analysis and repeat analysis is around 10-12%.


Again: If you use a different method the absolute concentratiosn measured in the samples can be different from method to method since bioanalytical methods are "semi-quantitative". However, if both methods are accurate and precise the slope of the curve should not be different i.e. the ratio of Cmax should be the same. When applying another method all samples are affected in the same way, there can not be a difference between test and reference samples. It is therefore absolute unlogical to have a shift in Cmax from 102% to 87% without having differences in method performance.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan

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