Bioequivalence and Bioavailability Forum • Different strengths

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

posted by ElMaestro – Denmark, 2014-12-21 21:42 (4208 d 12:41 ago) – Posting: # 14129
Views: 10,013

Hi again mittyri,

❝ For exapmle, the formulation 50mg is registered and we're going to conduct the study with the formulation 100 mg.

❝ The drug has linear PK to 120 mg according to the literature.

❝ Could we plan our study with ISV derived from the previous data? Is it safe enough?

A difficult topic. I am aware of people have a theoretical concern about ISV varying with strength but I don't remember ever having seen solid data quantifying the phenomenon.
I think I would just use the ISV from the previous study if that's available.

—
Pass or fail!
ElMaestro

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