Bioequivalence and Bioavailability Forum • Sample size + Limits Drug Interaction study

Sample size + Limits Drug Interaction study [Regulatives / Guidelines]

posted by hiren379 – India, 2014-02-19 14:38 (4514 d 19:05 ago) – Posting: # 12446
Views: 5,907

Hello friends,
We have developed a combination product [Drug A + Drug B] and we are planning a drug interaction study.
Design: 3 way cross over with following arms
Arm 01: Drug A alone
Arm 02: Drug B alone
Arm 03: Drug A + Drug B (Newly developed combination product)

Is it mandatory for USFDA that Cmax, AUC meet the traditional BE limits of 80 - 125 for claiming no DDI?
If the study fails for meet 80-125 limits, is it possible to justify on clinical grounds that such an effect is of no clinical relevance?
How to calculate sample size of DDI studies?
Since all the three products are developed by us on the same platform, we can assume zero / minimal variability associated with formulation difference. Is there any method to calculate the sample size based on true intrinsic variability of molecule only? This can reduce our sample size to some extent.

Complete thread:

Sample size + Limits Drug Interaction studyhiren379 2014-02-19 13:38
- FDA: DDI Interaction Helmut 2014-02-19 14:29
  - FDA: DDI Interaction hiren379 2014-02-19 14:51
    - FDA: DDI Interaction Helmut 2014-02-19 15:36
    - FDA: DDI Interaction jag009 2014-02-20 21:41
    - FDA: DDI Interaction ElMaestro 2014-02-20 22:27