Bioequivalence and Bioavailability Forum

Missed tablets administration in a steady state study [Study As­sess­ment]

posted by BE-proff – 2016-02-19 09:36 (3429 d 03:16 ago) – Posting: # 16009
Views: 7,605

Hi ElMaestro,

It's clear that money is the strongest motivator for people but what to do if all subjects have been already dosed and sampled and accountability showed missed administrations

What would you write in reports except statement of deviations?

Nobody can guarantee that a regulator will not reject your results saying they were obtained from deviated people

Complete thread:

• Missed tablets administration in a steady state study BE-proff 2016-02-18 17:56 
  • Missed tablets administration in a steady state study ElMaestro 2016-02-19 07:24
    • Missed tablets administration in a steady state studyBE-proff 2016-02-19 08:36
      • Missed tablets administration in a steady state study Ohlbe 2016-02-19 09:37
      • Missed tablets administration in a steady state study ElMaestro 2016-02-19 10:37
        • Missed tablets administration in a steady state study BE-proff 2016-02-19 12:18
          • Missed tablets administration in a steady state study ElMaestro 2016-02-19 16:39
            • Missed tablets administration in a steady state study BE-proff 2016-02-21 08:07
  • BE with PP-population Helmut 2016-02-21 15:06
    • BE with PP-population BE-proff 2016-02-25 07:53