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Dear all,
Does anyone know why bioequivalence studies for extended release formulations have to be performed at steady-state? Any comments will be appreciated.
Best regards
joan
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The following message was posted to: PharmPK
Not all ER tablets require Steady state BE. It depends on molecule and
indications
Regards
Chander Kazipeta
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Dear Chander,
Thanks for your help. Where can i find more information about this subject?
Best regards
joan
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The following message was posted to: PharmPK
Dear Joan,
In the future please give us more informations. ;-)
Regulations are different on this planet.
For an overview see here:
http://bebac.at/Guidelines.htm
Good luck,
Helmut
-
Ing. Helmut Schuetz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
web http://bebac.at/
forum http://forum.bebac.at/
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Dear Sir,
Steady state design are normally indicated in the following cases:
1. Dose or time dependant pharmcokinetics
2. Some modified release products (in addition to single dose investigations). Not for all extended release formulations.
3. Where problems of sensitivity preclude sufficiently precise plamsa concentration measurements after single dose administration.
4. If the intraindividual variability in the plasma concentration or disposition precludes the possibility of demonstrating the bioequivalence in a reasonably sized single-dose study and this variablity is reduced at a steady state.
For Extended Release tablets formulations that are likely to accumulate (i.e., AUCX / AUCI < 0.8), safety requires that steady-state studies be performed in addition to the single-dose studies. Where the AUCX / AUCI ratio cannot be reliably determined, accumulation must be assumed to occur.
The recommendation of doing steady state studies for extended release formulation depends on the molecule.
Thanks & Regards,
Dr.S.Gunasakaran,MD,
Azidus Research Laboratories, Chennai.
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