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RegisterBioequivalence study of Aspirin [Regulatives / Guidelines]
Hi,
As per the european guidelines, the parent compound (not metabolite) should be used for bioequivalence evaluation and in case of prodrugs the metabolite may be used for bioequivalence.
Aspirin is metabolised to salicylic acid in the body and for the BE assessment whether aspirin (parent) or salicylic acid (metabolite) shall be used for the BE study for EU submission. From the literature it was observed that the concentrations of aspirin were observed for only 3 to 4 hours after drug adminsitration and later on the concentration of salicylic acid is predominently available for about 10 to 12 hours.
Please provide your opinion for the selection of aspirin or salicylic acid as the analyte for BE comparision.
Regards
As per the european guidelines, the parent compound (not metabolite) should be used for bioequivalence evaluation and in case of prodrugs the metabolite may be used for bioequivalence.
Aspirin is metabolised to salicylic acid in the body and for the BE assessment whether aspirin (parent) or salicylic acid (metabolite) shall be used for the BE study for EU submission. From the literature it was observed that the concentrations of aspirin were observed for only 3 to 4 hours after drug adminsitration and later on the concentration of salicylic acid is predominently available for about 10 to 12 hours.
Please provide your opinion for the selection of aspirin or salicylic acid as the analyte for BE comparision.
Regards
Complete thread:
- Bioequivalence study of AspirinDebbie 2011-01-31 16:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioequivalence study of Aspirin ElMaestro 2011-01-31 16:59
- BE or biowaiver ? Ohlbe 2011-01-31 23:34
- BE or biowaiver ? Debbie 2011-02-01 16:36
- BE or biowaiver ? manan 2011-02-02 07:06
- BE or biowaiver ? Debbie 2011-02-01 16:36
Ing. Helmut Schütz