Bioequivalence and Bioavailability Forum • BE study involving injectable device

BE study involving injectable device [Design Issues]

posted by Ohlbe – France, 2014-08-25 01:40 (4325 d 09:59 ago) – Posting: # 13424
Views: 6,447

Dear Dan and John,

❝ The aim of a BE study is to show differences in formulations. As long as there is no difference in the way of administration or in technical performance.

True. But if the administration device differs between the two products and there is a technical difficulty in administering one of them, this may result in a different bioavailability if patients don't do the administration properly. In this regard I think it makes sense to ask the subjects to self-administer the products.

—
Regards
Ohlbe

Complete thread:

BE study involving injectable device jag009 2014-07-23 15:17
- BE study involving injectable device Dr_Dan 2014-07-25 12:18
  - BE study involving injectable device jag009 2014-08-05 19:30
    - BE study involving injectable device Dr_Dan 2014-08-06 07:45
      - BE study involving injectable device jag009 2014-08-08 16:53
        
        BE study involving injectable device Dr_Dan 2014-08-10 23:48
        
        BE study involving injectable deviceOhlbe 2014-08-24 23:40
- BE study involving injectable device ElMaestro 2014-08-05 23:39