Bioequivalence and Bioavailability Forum • BE study involving injectable device

BE study involving injectable device [Design Issues]

posted by Dr_Dan – Germany, 2014-07-25 14:18 (4351 d 14:59 ago) – Posting: # 13312
Views: 6,825

Dear John
In order to understand your question could you please provide some more information? Are you talking about some kind of intramuscular/subcutaneous depot formulation? Is the device biodegradable or must it be removed by surgery?
In general such devices act over a long period of time and therefore you will end up with a parallel group design. Variability strongly depends on the solubility of the drug, the release mechanism and the metabolism of the study participants. To my experience the variability will be comparably high.
Kind regards
Dr_Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

BE study involving injectable device jag009 2014-07-23 15:17
- BE study involving injectable deviceDr_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 device Ohlbe 2014-08-24 23:40
- BE study involving injectable device ElMaestro 2014-08-05 23:39