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Registerpharmacokinetic equivalent/bioequivalent [Design Issues]
Dear yuk,
Pharmaceutic equivalence is a evaluation of formulations according to a Pharmacopeia Monograph and dissolution profile evaluated by f2 (model independent method)
Bioequivalence is a evaluation of formulations considering the pharmacokinetic profile in vivo and the confidence interval (CI90%) to parameters AUC and Cmax (0.8-1.25)
Therefore, I do not know the concept of pharmacokinetic equivalence, maybe the right word is bioequivalence or relative bioavailability.
Regards
Daniel
Pharmaceutic equivalence is a evaluation of formulations according to a Pharmacopeia Monograph and dissolution profile evaluated by f2 (model independent method)
Bioequivalence is a evaluation of formulations considering the pharmacokinetic profile in vivo and the confidence interval (CI90%) to parameters AUC and Cmax (0.8-1.25)
Therefore, I do not know the concept of pharmacokinetic equivalence, maybe the right word is bioequivalence or relative bioavailability.
Regards
Daniel
Complete thread:
- pharmacokinetic equivalent/bioequivalent yvk 2007-04-25 05:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- pharmacokinetic equivalent/bioequivalentdrcampos 2007-04-25 15:26
- pharmacokinetic equivalent/bioequivalent yvk 2007-04-26 09:57
- pharmacokinetic equivalent/bioequivalent rahul_hi1234 2007-04-26 10:34
- pharmacokinetic equivalent/bioequivalent Jaime_R 2007-04-26 12:51
- pharmacokinetic equivalent?! Jaime_R 2007-04-26 13:50
- pharmacokinetic equivalent/bioequivalent rahul_hi1234 2007-04-26 10:34
- pharmacokinetic equivalent/bioequivalent yvk 2007-04-26 09:57
- pharmacokinetic equivalent/bioequivalentdrcampos 2007-04-25 15:26
Ing. Helmut Schütz