Bioequivalence and Bioavailability Forum • General remarks

General remarks [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2015-02-02 15:06 (3754 d 06:16 ago) – Posting: # 14353
Views: 22,604

Hi nobody,

❝ So: make your 25-28% something formulation…

Scaling depends on the CV_w of the reference. If you are able to manufacture a new product with smaller variability you get a reward in sample size (same widening of the AR but tighter CI). Example (T/R 0.9, 80% power, 4-period full replicate):

CV_wR CV_wT n 0.35 0.35 34 0.35 0.25 26

❝ …go with 31% in the study and you are on the lucky side of life, hu?

If you mean that the true CV_wR is 25–28% and you observe 31%, yes. You scale the AR to 79.44–125.89% although the reference is not highly variable. Lucky punch for the producer, slightly increased risk for the patient.

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Helmut Schütz

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Complete thread:

EMA oracle Helmut 2015-01-27 16:27 [RSABE / ABEL]
- EMA oracle nobody 2015-01-27 17:07
- Personal opinion ElMaestro 2015-01-27 17:56
- EMA oracle d_labes 2015-01-27 19:44
  - EMA oracle nobody 2015-01-28 09:04
    - EMA oracle ElMaestro 2015-01-28 13:11
- Response from Alfredo García-Arieta Helmut 2015-01-30 10:55
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        General remarks Helmut 2015-02-02 00:48
        
        General remarks nobody 2015-02-02 08:09
        
        General remarksHelmut 2015-02-02 14:06
        
        TIE: questions mittyri 2015-02-03 12:44
        
        TIE: questions Helmut 2015-02-03 13:24
        
        FDA RSABE & alpha inflation d_labes 2015-02-03 12:02
        
        FDA RSABE & alpha inflation Helmut 2015-02-03 12:22
        
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        FDA RSABE & alpha inflation Helmut 2015-02-03 13:41
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        New Zealand nobody 2015-02-02 08:07