Bioequivalence and Bioavailability Forum

blood sampling [Study Performance]

posted by Pankaj Mishra – Mumbai, India, 2009-12-10 11:05 (5607 d 08:00 ago) – Posting: # 4456
Views: 22,893

Dear Ratnakar,

❝ Generally we have a window of 2 min for inhouse sampling and for ambulatory samples we have a window of 1 hr mentioned in the protocol, now my question is should we use actual time for all the deviation irrespective as mentioned above (i.e. even the sample is delayed by 1 min also) or for only those samples for which protocol deviation required to be filed?

❝

❝ Currently we have mentioned actual time to be considered for all the deviations even it is for 1 min also.

I think we should use an acceptable limit of ± 2 minutes for all the samples whether in-house or ambulatory and we can mention this in our SOP. Why 1 hr for ambulatory when that is also scheduled? I don't think any regulatory may have an objection on this approach except for those case where we have first point Cmax and half life is very low (e.g. 1 hr). In those cases we may restrict ourselves to 1 min of acceptable deviation.

Regards,
Pankaj Mishra

—
Pankaj Mishra

Complete thread:

blood sampling drdds 2007-11-03 11:42 [Study Performance]
- blood sampling Ohlbe 2007-11-04 00:29
- blood sampling Helmut 2007-11-04 01:13
  - blood sampling Ohlbe 2007-11-04 13:25
    - blood sampling Helmut 2007-11-04 13:45
      - blood sampling Dr.Tarak Parikh 2007-11-06 09:59
        
        First Time Cmax Helmut 2007-11-09 17:27
      - blood sampling ratnakar1811 2009-12-10 07:05
        
        blood samplingPankaj Mishra 2009-12-10 10:05
        
        blood sampling ratnakar1811 2009-12-10 12:46
        
        blood sampling Pankaj Mishra 2009-12-11 10:49
        
        Actual vs. scheduled time Helmut 2009-12-11 14:03
        
        blood sampling Helmut 2009-12-10 13:13
        
        blood sampling ratnakar1811 2009-12-11 10:16

blood sampling [Study Per­for­mance]

Complete thread:

blood sampling [Study Performance]