Bioequivalence and Bioavailability Forum

Hi ElMaestro,

Thanks to share your opinion

❝ We have a Flemish saying here in Gent. It goes like this:

❝ " Dans un bol ou saladier, râper les pommes de terre et saler. Ajouter un peu de farine, les oeufs et le persil. Faire chauffer une bonne quantité d'huile dans une poêle et verser la pâte par petites cuillerées. Bien faire dorer les beignets de chaque côté. Servir avec une bonne salade."

This part corresponds to a french receipe known as crique. I'm not sue it is intentional (I'm a native french speaker), but as far as I know, this taste good

❝ -which means in direct English translation: "It is better to be on the safe side when conducting bioequivalence studies."

I totally agree with your conclusion and since it appears that I have probably hands free I give you different options I computed based on Helmut ideas (One-sided, alpha=20%) :

One-sided, alpha=20%:
     10   15   20   30   40    50
4  21.4 32.4 43.8 68.7 97.2 131.1
6  15.6 23.6 31.6 48.2 65.8  84.8
12 12.7 19.1 25.6 38.7 52.1  66.0
16 12.2 18.3 24.4 36.9 49.5  62.5
24 11.6 17.5 23.3 35.1 47.1  59.3
32 11.3 17.0 22.7 34.2 45.8  57.6

Two-sided, alpha=20%:
     10   15   20    30    40    50
4  31.5 48.5 67.2 112.5 175.8 270.4
6  19.5 29.5 39.9  61.9  86.5 114.7
12 14.4 21.6 29.0  44.0  59.7  76.3
16 13.4 20.2 27.0  40.9  55.3  70.2
24 12.5 18.8 25.2  38.0  51.2  64.7
32 12.1 18.1 24.2  36.6  49.1  62.0

One-sided, alpha=5%:
     10   15    20    30    40    50
4  46.3 73.7 107.2 209.0 413.0 874.7
6  24.0 36.5  49.7  79.0 114.3 158.5
12 16.0 24.1  32.4  49.4  67.6  87.3
16 14.6 22.0  29.5  44.9  61.0  78.0
24 13.4 20.1  26.9  40.8  55.0  69.9
32 12.8 19.2  25.6  38.7  52.2  66.0

Two-sided, alpha=5%:
     10    15    20    30     40     50
4  69.4 118.7 192.5 539.3 1872.2 8200.5
6  29.3  44.9  61.8 101.8  155.1  230.5
12 17.6  26.6  35.8  55.1   76.1   99.4
16 15.8  23.9  32.0  48.9   66.8   86.1
24 14.2  21.3  28.6  43.4   58.8   75.1
32 13.4  20.1  26.9  40.8   55.1   70.0

If we assume that alpha=5% is too stringent, with alpha=20%, 16 people for a pilot study seems a good tradeof either one or two-sided.
Any opinions?