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RegisterBE at Steady state [Design Issues]
Dear Dr. Helmut,
Thanks for your clarification on the issues of steady state BE. When one of my colleague submitted dossier for fluoxetine 20 mg capusule in Sweden it has been queried by Swedish authorities why we had submitted a single dose study on fluoxetine for estabilishing BE. Reason for this is (given by swedish authorities) both fluoxetine and its metabolite nor fluoxetine follows nonlinear kinetics. As per their view, "for substances with nonlinear kinetics normally BE should be estabilshed during the most saturated condtion achieved therapeutically" (Whether it means Steady State conditions ??!!)
Kindly help me in providing a proper justification.
Thanks for your clarification on the issues of steady state BE. When one of my colleague submitted dossier for fluoxetine 20 mg capusule in Sweden it has been queried by Swedish authorities why we had submitted a single dose study on fluoxetine for estabilishing BE. Reason for this is (given by swedish authorities) both fluoxetine and its metabolite nor fluoxetine follows nonlinear kinetics. As per their view, "for substances with nonlinear kinetics normally BE should be estabilshed during the most saturated condtion achieved therapeutically" (Whether it means Steady State conditions ??!!)
Kindly help me in providing a proper justification.
Complete thread:
- BE at Steady state Ahmed 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 stateAhmed 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 stateAhmed meeran 2006-10-03 13:09
- BE at Steady state Helmut 2006-09-21 13:38
Ing. Helmut Schütz