Bioequivalence and Bioavailability Forum • FDA: DDI Interaction

FDA: DDI Interaction [Regulatives / Guidelines]

posted by jag009 – NJ, 2014-02-20 22:41 (4510 d 23:32 ago) – Posting: # 12467
Views: 5,141

Hi,

❝ We are sure that there shall be no/very less variability due to formulation as all the three products are manufactured by us on same platform with same excipients/process/manufacturing location, which is not the case in BE study as Test and reference product are based on different platforms/manufacturing process/location etc. Hence we want to remove this variability part from total variability while calculating sample size

How do you plan to remove this variability? :confused:

John

Complete thread:

Sample size + Limits Drug Interaction study hiren379 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 Interactionjag009 2014-02-20 21:41
    - FDA: DDI Interaction ElMaestro 2014-02-20 22:27