Bioequivalence and Bioavailability Forum • handling of missing data

handling of missing data [NCA / SHAM]

posted by gracehung – Taiwan, 2013-05-20 09:35 (4369 d 22:49 ago) – Posting: # 10603
Views: 22,496

I have one question about the handling of the missing data, and need your advice.
My question is:
As in BE study, One sample’s actual sampling time was miss recorded. However as according to protocol, this sample was analyzed by our analytical laboratory.

Considering from PK personnel’s aspect, as it was not specified in protocol, how would you handling this missed time point at statistical analysis?
Will this data be included in statistical analysis? If yes, what is the handling procedure?
If the data is excluded, what kind of method would you use in calculate your AUC?
1. Would you adapt interpolation method?
2. If yes, would you adapt logarithmic interpolation or linear interpolation?
Is there any guideline or reference document we could follow?

Complete thread:

handling of missing datagracehung 2013-05-20 07:35 [NCA / SHAM]
- Lin-up/log-down trapezoidal avoids most trouble Helmut 2013-05-20 14:22
  - Lin-up/log-down trapezoidal avoids most trouble yjlee168 2013-05-22 08:25
    - Multiple peaks: fallback to linear trapezoidal Helmut 2013-05-22 20:25
      - Multiple peaks: fallback to linear trapezoidal yjlee168 2013-05-22 21:57
        
        No interpolation Helmut 2013-05-22 23:25
        
        No interpolation yjlee168 2013-05-23 11:43
        
        Spaghetti & other pasta Helmut 2013-05-23 15:15
        
        Spaghetti & other pasta yjlee168 2013-05-23 20:47
        
        Spaghetti & other pasta Helmut 2013-05-23 21:29
        
        Spaghetti & other pasta yjlee168 2013-05-23 22:46
        
        Spaghetti & other pasta Helmut 2013-05-24 01:24
        
        Spaghetti & other pasta yjlee168 2013-05-24 09:17
        
        No interpolation Ken Peh 2013-05-30 19:55
        
        Different algos! Helmut 2013-05-30 22:38
        
        Different algos! Ken Peh 2013-06-03 17:52
        
        Calculate what? Helmut 2013-06-03 18:11
    - Lin-up/log-down trapezoidal example Helmut 2013-05-25 15:09
      - Lin-up/log-down trapezoidal example yjlee168 2013-05-25 19:45
- handling of missing data Ohlbe 2013-05-20 21:45
  - Sorry Helmut 2013-05-21 13:53
    - Sorry gracehung 2013-05-23 01:06
      - Uncertain time point Helmut 2013-05-23 01:35