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Falisa_Mustafa ☆ Malaysia, 2012-01-20 05:06 (4881 d 15:30 ago) Posting: # 7969 Views: 2,825 |
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hi, i would like to seek some advice regarding the analysis of study sample from regulatory point of view. scientifically, would it be acceptable to not analyze all study samples from a in a single run (i.e multiple runs) as long as the bioanalytical method has completely been validated and documented acceptable inter-assay variability?. is there any justification behind the acceptance of single / multiple run(s) analysis results? is there any references/guidelines that i can refer to regarding this matter? thanx! |
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Helmut ★★★   Vienna, Austria, 2012-01-20 14:22 (4881 d 06:14 ago) @ Falisa_Mustafa Posting: # 7981 Views: 2,249 |
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Dear Mustafa! ❝ […] from regulatory point of view. ❝ ❝ scientifically, would it be acceptable to not analyze all study samples from a in a single run (i.e multiple runs) as long as the bioanalytical method has completely been validated and documented acceptable inter-assay variability?. ❝ is there any justification behind the acceptance of single / multiple run(s) analysis results? Regulatory or scientific POV?.  ❝ is there any references/guidelines that i can refer to regarding this matter? See EMA’s GL (2011) Section 5.1. I would go with a single batch whenever possible. Even if you have low inter-batch variability, you might see a certain shift within the plasma profiles. If samples are analyzed in a cross-over manner, AUC and Cmax should not be affected, but estimating the elimination might give you headaches. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz