Bioequivalence and Bioavailability Forum • About "PK repeats"

About "PK repeats" [Software]

posted by Ohlbe – France, 2009-09-15 00:01 (6115 d 18:13 ago) – Posting: # 4200
Views: 19,125

Dear Helmut,

❝ why did it never happen to me? Pure chance or because I always state what is planned not only in an SOP but also in the protocol? I’m guessing that a lot of troubles are originating from all types of post-hoc ‘decisions’.

Agreed.

❝ We still reanalyse not only the ‘suspect value’, but neighbouring values as well. These values serve as internal validators.

Yes, I still do like this concept.

❝ ❝ IMHO it is a real pity that regulators are allergic to "PK repeats".

❝

❝ Are they? Is it because repeats are generally badly documented or do you think that there are other reasons?

Paranoia is the other reason, I guess. Afraid that the lab might repeat some samples so that borderline 90 % CI switch from the wrong side of the border to the right. Would take quite a few repeats for AUC, but not that many for Cmax. But then we're back to the discussion on blind review by an experienced pharmacokineticist.

❝ Maybe Pharsight should consider a code for such a value ('Rejected' instead of 'Missing'?). Numerically it could be handled like a missing one – but it❝ should be clear in the output that an experimental result exists.

Suggestion supported.

Regards
Ohlbe

—
Regards
Ohlbe

Complete thread:

BLQ values in Winnonlin Dr. Harish L. Rao 2009-09-10 07:53
- BLQ values in Winnonlin Ohlbe 2009-09-11 00:18
  - BLQ values in Winnonlin > Status codes tool SDavis 2009-09-11 08:13
    - BLQ values in Winnonlin > Status codes tool Ohlbe 2009-09-11 22:19
      - Irregular profiles Helmut 2009-09-14 17:11
        
        About "PK repeats"Ohlbe 2009-09-14 22:01
        
        About "PK repeats" Helmut 2010-10-21 15:51
        
        About "PK repeats" Ohlbe 2010-10-21 16:38
        
        About "PK repeats" Helmut 2010-10-21 17:01
        
        About "PK repeats" Ohlbe 2010-10-21 17:32
        
        slowly going off-topic Helmut 2010-10-21 18:47
        
        About "PK repeats" ElMaestro 2010-10-21 16:56
        
        About "PK repeats" Helmut 2010-10-21 18:02
        
        BLQ Values in Winnonlin Dr. Harish L. Rao 2009-09-15 05:45