Missed tablets administration in a steady state study [Study Assessment]
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?
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
- Missed tablets administration in a steady state study ElMaestro 2016-02-19 16:39
- Missed tablets administration in a steady state study BE-proff 2016-02-19 12:18
- Missed tablets administration in a steady state study BE-proff 2016-02-19 08:36
- BE with PP-population Helmut 2016-02-21 15:06
- BE with PP-population BE-proff 2016-02-25 07:53
- Missed tablets administration in a steady state study ElMaestro 2016-02-19 07:24