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Mitesh Panchal ☆ India, 2015-08-30 06:54 (3556 d 18:03 ago) Posting: # 15363 Views: 6,249 |
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Hello Everyone, I have faced following issue, I have found concentration in pre-dose sample and that concentration is higher than last sample / time point of Period 01 (i.e. P02, pre-dose concentration is higher than its preceding sample). In such case we need to repeat the sample (i have repeated sample). My doubt is, If i found repeated value different from initial value then what to do? we need to accept which value??? (Initial / Repeated / we need to reported as NR) eg. Initial Value - 251 ng / mL Repeated Value - 0.oo ng / mL (totally different value) Please give me your suggestions. Regards, Mitesh Panchal |
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mittyri ★★ Russia, 2015-08-30 21:24 (3556 d 03:33 ago) @ Mitesh Panchal Posting: # 15364 Views: 5,130 |
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Dear Mitesh, I think you can find the answer in the following topics: here, here or here In a nutshell: EMA BE GL states: Reanalysis of study samples should be predefined in the study protocol (and/or SOP) before the actual start of the analysis of the samples. EMA bioanalytical method validation GL states that: In case of reanalysis because of positive pre-dose samples or because of a pharmacokinetic reason, the reanalysed samples should be identified and the initial value, the reason for reanalysis, the values obtained in the reanalyses, the finally accepted value and a justification for the acceptance should be provided Hope it helps — Kind regards, Mittyri |
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Mitesh Panchal ☆ India, 2015-08-30 22:14 (3556 d 02:43 ago) (edited on 2015-08-30 22:30) @ mittyri Posting: # 15365 Views: 5,149 |
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Ing. Helmut Schütz