Bioequivalence and Bioavailability Forum

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

posted by BE-proff – 2016-02-18 18:56 (3428 d 13:38 ago) – Posting: # 16007
Views: 8,685

Hi All,

Let's assume that I want to conduct steady state study with the following terms:

- Test and Reference are administered in 7 days; 8th day is a PK-session with blood sampling
- Test is to be taken twice a day
- Reference is to be taken 3 times a day
- 2 period, cross-over study

Drug accountability done by a CRA showed several missed administrations of medications.

Is it possible to assess how missed administrations influenced on concentrations and therefore on PK-parameters?

Complete thread:

• Missed tablets administration in a steady state studyBE-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 study BE-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