Bioequivalence and Bioavailability Forum • Calculation of ISR deviation

Calculation of ISR deviation [Bioanalytics]

posted by Helmut – Vienna, Austria, 2013-04-25 04:00 (4812 d 03:33 ago) – Posting: # 10493
Views: 9,037

Dear Ohlbe,

❝ I was actually thinking of the white paper of the "Crystal City 3.5" meeting of 2008, by Douglas Fast et al.

OK, here we are:

% Difference = 100 × (Repeat – Original) / Mean

❝ Regarding the number of samples, do you know this paper by Hoffman ? Too much stats in it for my brain, but you should be able to understand it better ;-)

I like it. Of course it makes sense to come up with a number of samples depending on the variability. 5 (or 10%) of the study’s samples are arbitrary. Fig. 4 is telling: With a CV of 10% it is simply irrelevant whether 40 or 160 samples are tested.

Edit: R-code in this post.

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Complete thread:

Calculation of ISR deviation Helmut 2013-04-23 19:30
- Calculation of ISR deviation ElMaestro 2013-04-23 20:30
  - I see… Helmut 2013-04-23 22:08
  - Calculation of ISR deviation Roberto 2013-12-09 12:52
- Calculation of ISR deviation Ohlbe 2013-04-24 09:40
  - Calculation of ISR deviation Helmut 2013-04-24 14:07
    - Calculation of ISR deviation Ohlbe 2013-04-24 22:37
      - Calculation of ISR deviationHelmut 2013-04-25 02:00