Bioequivalence and Bioavailability Forum • Different strengths

Different strengths – different ISV? [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2014-12-22 04:07 (4207 d 01:08 ago) – Posting: # 14134
Views: 10,044

Hi ElMaestro & Mittyri,

❝ I am aware of people have a theoretical concern about ISV varying with strength…

Are these the ones wearing waist-belts plus suspenders to exercise caution?

❝ … but I don't remember ever having seen solid data quantifying the phenomenon.

So do I.

❝ I think I would just use the ISV from the previous study if that's available.

Yep – with one possible exception. If you enter nonlinear PK (high doses: saturation of enzymes and/or transporters) genetics and day-to-day variability may become increasingly important. Add some % to the %. Don’t ask me how much. If in doubt, run a pilot.

@Mittyri: I would not worry in your case.

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Complete thread:

Different strengths – different ISV? mittyri 2014-12-21 18:04
- Different strengths – different ISV? ElMaestro 2014-12-21 20:42
  - Different strengths – different ISV?Helmut 2014-12-22 03:07
    - Different strengths – thanks for advice mittyri 2014-12-22 20:33
    - Planning the study based on the previous results mittyri 2015-02-11 19:23
      - Planning the study based on the previous results ElMaestro 2015-02-11 20:29
      - Conservatism Helmut 2015-02-12 13:31