Bioequivalence and Bioavailability Forum

Missing values [Study Performance]

posted by ElMaestro – Denmark, 2008-07-31 12:38 (6544 d 11:13 ago) – Posting: # 2113
Views: 20,789

❝ ❝ "Exclusion of data can never be accepted on basis of stat analysis or ❝ for PK reasons alone."

❝ IMHO defining ‘critical regions’ of the profile in the protocol is not a bad idea. No “[…] PK reasons alone”, but common sense added!

❝ If one wants to come up with a hard-core justification of the ‘critical regions’: perform PK modeling (pilot study or literature data) and plot the partial derivatives of parameters vs. time; extremes (min/max) will indicate most influential time points. Remark: never seen this in a protocol – maybe freaks like me do it at home. :cool:

Hi,

Dat's a good point to make, HS.
But I think the current trend is towards more 'cook book' and less science or judgment. It might be difficult to make a recipe for this situation which is not based on some degree of subjectivity (subjectivity- sometimes disguised as 'common sense' - is something that can be tricky to handle for regulators as well as applicants, I think). Let me emphasize, I like the idea nevertheless.
However, I could also imagine regulators thinking "Plan the study well, make sure it is robust towards 'eventualities'. If the loss of two samples (or whatever) is remotely/reasonably possible then of course a study should be planned so that such an event does not scr¤w it all up. If a study is planned well it will not be necessary to fiddle around with data." or something along those lines.

N'est-ce pas?

EM.

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Edit: Full quote removed. Please see this post! [Jaime]

Complete thread:

Missing values ratnakar1811 2008-04-02 14:07 [Study Performance]
- Missing values Helmut 2008-04-02 14:54
  - Missing values atish_azad 2008-07-29 11:03
    - Missing values ElMaestro 2008-07-29 11:21
      - Missing values Helmut 2008-07-29 21:40
        
        Missing valuesElMaestro 2008-07-31 10:38
        
        Missing values Helmut 2008-07-31 14:36
    - Missing values Helmut 2008-07-29 21:18
- Missing values martin 2008-07-29 13:56
  - Missing values Helmut 2008-07-29 22:18
    - Missing values martin 2008-07-30 10:28
      - ITT vs. PP data sets Helmut 2008-07-30 13:30
      - Missing values d_labes 2008-07-30 13:39
        
        Missing values Helmut 2008-07-30 14:34
        Missing values martin 2008-07-30 14:50
        
        Missing values Helmut 2008-07-30 17:14
        
        Missing values d_labes 2008-07-31 09:18

Missing values [Study Per­for­mance]

Complete thread:

Missing values [Study Performance]