Bioequivalence and Bioavailability Forum

no of samples above ULOQ [Bioanalytics]

posted by Ken Peh – Malaysia, 2014-08-14 19:40 (4329 d 10:51 ago) – Posting: # 13379
Views: 13,112

Dear Members,

In a BE study involving 26 subjects, 20 subjects had drug level within standard calibration curve. However, the last 6 subjects had many points above ULOQ. We did not go for partial method validation as we thought the numbers would not be many. We continued the analysis until we completed all the samples.

We diluted and reanalyzed these samples. The total number of reanalyzed samples is about 11% of the total number of samples.

How many samples are allowed to be reanalyzed ? Will too many repeats invalid the study ? How many is considered as too many?

Your kind comment is highly appreciated.

Thank you.

Regards,
Ken

Complete thread:

• no of samples above ULOQKen Peh 2014-08-14 17:40 
  • no of samples above ULOQ ElMaestro 2014-08-14 19:28
  • Pattern? Helmut 2014-08-15 04:16
    • Pattern? Ken Peh 2014-08-17 20:31
      • Not deserving an answer? Helmut 2014-08-17 21:27
    • Combinatorics ElMaestro 2014-08-17 23:17
      • Well done! Helmut 2014-08-17 23:43
    • Pattern? ElMaestro 2014-08-18 23:54
      • Few runs? Helmut 2014-08-19 03:04
        • Few runs? ElMaestro 2014-08-19 23:32
          • Few runs? ElMaestro 2014-08-20 00:07
            • Hazelnut-sized brain Helmut 2014-08-20 11:27