Bioequivalence and Bioavailability Forum • Manual reintegration!

Manual reintegration! [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2008-08-28 14:44 (6138 d 17:36 ago) – Posting: # 2272
Views: 24,138

❝ IMHO, in any case the analytical 'quality' will decrease. The section should be deleted entirely - it's simply stupid.

Hi,

there is actually a relevant parallel in the preclinical standard package and certain types of human pharmacology studies. When (new) drugs are evaluated for the potential to provoke torsades-de-pointes (pardon my French!), it is done by ECG's coupled with software for semi-automated evaluation of the QT-intervals. As far as I know, the ECG software automatically finds/calculates/measures the QT-interval, while a technician goes manually through such data to verify the intervals are reasonably accurately identified. In certain cases (s)he may correct the interval but there is no requirement for printing copies of corrected and uncorrected ECG's, afaik. This is pretty much a similar situation, isn't it? It seems to work well for the ECG's that way. I am not aware of any people dropping dead because the software failed and the corrected and uncorrected QT was not printed.

The software companies might love the idea, though. It would give them an incentive to develop options to scan through audit trails, find chromatograms that have been manually integrated and print them out along with some brainy statistics on the impact of the manual corrections, all in a format suited to the European regulator's eye.

But after all, do thoughts about chromatolophystic integration really belong in the BE-guideline? If European regulators really have something important to say about integration of chromatograms for the bioanalysis for inv. of BE, wouldn't it be relevant to assume they would expect the same standards for PK analyses for other drugs than just the BE ones? If yes, then the whole issues does not belong in the BE guideline.
It would be much more relevant to simply write such things in a separate guideline dealing with bioanalysis in a general perspecitve - such a GL is much wanted anyway. All in all, my solution is:

Re-think the integration issues, possibly get inspiration from ICH E14.
Remove the integration issues from the BE guideline.
Get started on a general bioanalysis guideline and include the thoughts about integration there.

EM.

Complete thread:

Critical review of EU BE guideline (Rev.1) Helmut 2008-08-22 14:30 [Regulatives / Guidelines]
- Critical review of EU BE guideline (Rev.1) d_labes 2008-08-22 15:42
  - Critical review of EU BE guideline (Rev.1) Helmut 2008-08-23 02:02
    - Critical review of EU BE guideline (Rev.1) d_labes 2008-08-25 09:14
      - Variations Helmut 2008-08-25 11:06
- Critical review of EU BE guideline (Rev.1) Jaime_R 2008-08-23 16:47
  - Critical review of EU BE guideline (Rev.1) Ravi 2008-08-25 08:19
    - Two Stage Design Helmut 2008-08-25 11:43
      - Two Stage Design JPL 2008-08-28 09:44
        
        Two Stage Design Helmut 2008-08-28 11:50
        
        Two Stage Design d_labes 2008-08-28 12:09
        Sequential Design Helmut 2008-11-05 13:22
  - Critical review of EU BE guideline (Rev.1) banusunman 2008-08-26 16:56
    - Washout Helmut 2008-10-15 16:02
- Critical review of EU BE guideline (Rev.1) d_labes 2008-08-25 09:49
  - Critical review of EU BE guideline (Rev.1) Helmut 2008-08-25 12:11
    - Critical review of EU BE guideline (Rev.1) d_labes 2008-08-25 13:03
    - Urban legend? Helmut 2008-11-21 16:06
      - Urban legend? d_labes 2008-11-24 15:06
- Critical review of EU BE guideline (Rev.1) d_labes 2008-08-25 11:16
- Critical review of EU BE guideline (Rev.1), tmax, MRT, LZ d_labes 2008-08-25 11:32
  - Critical review of EU BE guideline (Rev.1), tmax, MRT, LZ Helmut 2008-08-25 13:10
  - tmax, nonparametrics Helmut 2008-10-13 15:38
    - tmax, nonparametrics d_labes 2008-10-14 08:33
      - tmax, nonparametrics Helmut 2008-10-14 11:29
      - tmax, Canadian approach Helmut 2008-11-21 15:41
        
        tmax, Canadian approach d_labes 2008-11-24 13:53
        
        Early exposure, Canadian approach: GMR only! Helmut 2009-02-08 00:44
        
        Early exposure, Canadian approach: GMR only! d_labes 2009-02-09 08:50
        
        tmax; another example Helmut 2008-12-25 15:59
- Automatic integration janmacek 2008-08-27 12:21
  - Automatic integration Ohlbe 2008-08-27 14:49
    - Manual reintegration! H_Rotter 2008-08-28 11:28
      - Manual reintegration!ElMaestro 2008-08-28 12:44
- Subject accountability, Proc MIXED or equivalent d_labes 2008-09-02 11:13
  - Subject accountability, Proc MIXED or equivalent Ohlbe 2008-09-02 15:20
    - Subject accountability, Proc MIXED or equivalent d_labes 2008-09-02 16:30
- partial AUC, early exposure d_labes 2008-09-03 08:35
- HVDs? Helmut 2008-09-23 12:52
  - HVDs? d_labes 2008-09-23 14:20
  - HVDs? Helmut 2009-01-20 14:33
  - E.g., omeprazole Helmut 2009-03-06 17:21
- BCS-based Biowaiver Helmut 2008-09-25 15:48
  - Dissolution update Helmut 2008-10-13 12:43
- EUFEPS workshop Helmut 2008-12-23 17:03