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RegisterBE at Steady state [Design Issues]
Dear Dr. Helmut
All the regulatory guidlines talks about conducting Bioequivalence study in single dose and at steady state conditions. For which type of drugs conducting a Bioequivalence study at steady state conditions is necessary.
For performing Bioequivalence study at steady state whether the sample size calculation is same as that of single dose study.
If Bioequivalence study is performed at steady state whether it will meet the acceptance criteria with small no of subjects than a single dose study.
Please guide me in these issues
Ahmed
All the regulatory guidlines talks about conducting Bioequivalence study in single dose and at steady state conditions. For which type of drugs conducting a Bioequivalence study at steady state conditions is necessary.
For performing Bioequivalence study at steady state whether the sample size calculation is same as that of single dose study.
If Bioequivalence study is performed at steady state whether it will meet the acceptance criteria with small no of subjects than a single dose study.
Please guide me in these issues
Ahmed
Complete thread:
- BE at Steady stateAhmed meeran 2006-09-12 06:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE at Steady state Helmut 2006-09-21 13:38
- BE at Steady state Ahmed meeran 2006-10-03 13:09
- Nonlinear PK (Sweden) Helmut 2006-10-03 13:55
- Nonlinear PK (Sweden) Ahmed meeran 2006-10-10 14:02
- Nonlinear PK (Sweden) Ahmed meeran 2006-10-30 11:27
- Steady state design (EU) Helmut 2006-10-30 13:40
- Nonlinear PK (Sweden) Helmut 2006-10-03 13:55
- BE at Steady state Ahmed meeran 2006-10-03 13:09
- BE at Steady state Helmut 2006-09-21 13:38
Ing. Helmut Schütz