Bioequivalence and Bioavailability Forum • IS carry-over?

IS carry-over? [Bioanalytics]

posted by Emrah Soner Özdeş – Turkey, 2014-11-27 11:28 (3832 d 12:51 ago) – Posting: # 13927
Views: 14,147

Hi again Helmut. The previous values were from another study. Here are the values from the current study and the thing you ask for.

Conc: 0.00
Re-analysis 1: 2.63
Re-analysis 2: 2.15
Means of Reanalyses: 2.39
Reported Conc: NR

❝ ❝ It is reported as "Fault in the sample processing".

❝

❝ OK, but how can you know that? Was anything documented in the lab journal like “I’m not sure whether I added the IS to this sample”?

I guess I wont be able to access lab journals.

❝ NR because “duplicate repeats were more than 20 percent different from one another”. That’s a matter of perspective:

❝ Re-analysis 1: 8.76 (+21.0% of 7.24, –9.5% of x)

❝ Re-analysis 2: 7.24 (–19.9% of 8.76, +9.5% of x)

❝ Obviously the decision to not report the value was based on the first replicate – why not on the second? Looks like an ambiguity in the SOP. :cherry picking:

In case of these values original value is 0.00 which makes the situation more interesting i guess. Flow Chart states that If duplicates differ from each other more than 20%, the next step is checking whether difference between each duplicate and original is more than 20%. According to Lab, the difference is more than %20 and hence the value is "NR". But in my opinion it is "Not Applicable" to find the percent difference from a value of "0.00"

❝ Can you give us:

❝ – The LLOQ and ULOQ of the method.

1.31 - 193.21 ng/mL

❝ – The concentration of samples analyzed in the batch before and after the doubtful value.

❝ – The concentration of samples of the subject’s profile before and after the doubtful value + their sampling time points.

0.0-0.00
0.8-2.52
1.5-10.79
3.0-32.81
4.5-61.07
5.0-69.93
5.5-76.10
6.0-76.64
6.5-83.04
7.0-89.39
7.5-84.73
8.0-88.83
10.0-89.91
12.0-64.55
24.0-17.11
48.0-4.74
72.0-NR

❝ – The ranges of C_max-values in the study.

43.41 - 170.70 ng/mL

Regards

Complete thread:

Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 07:25
- Handling "Not Reportable" Data ElMaestro 2014-11-21 07:34
  - Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 07:54
    - Handling "Not Reportable" Data nobody 2014-11-21 08:07
      - Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 08:18
        
        Handling "Not Reportable" Data ElMaestro 2014-11-21 09:53
        Handling "Not Reportable" Data nobody 2014-11-21 11:11
        
        Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 16:14
        
        IS carry-over? Helmut 2014-11-21 16:45
        
        IS carry-over? nobody 2014-11-21 17:19
        IS carry-over? Emrah Soner Özdeş 2014-11-24 08:58
        IS carry-over?Emrah Soner Özdeş 2014-11-27 10:28
        
        Another story! Helmut 2014-11-27 14:21
        
        Another story! Emrah Soner Özdeş 2014-11-28 10:00
        Another story! nobody 2014-11-28 10:18
    - Handling "Not Reportable" Data AngusMcLean 2014-11-28 19:09
      - EMA and similar regulations… Helmut 2014-11-28 19:16
        
        EMA and similar regulations… jag009 2014-12-01 19:54