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RegisterBioequivalence criteria for endogenous drug [Regulatives / Guidelines]
Dear Mr.Pash413,
The primary Pharmacokinetic parameters need to estimated for Endogenous substances are Cmax, AUC0-t and AUC0-inf. Bioequivalence criteria need to evaluated for Cmax, AUC0-t and AUC0-inf. FDA will not usually accept, if you submit AUC0-inf data only as supportive evidence excluding from Bioequivalence criteria.
The primary Pharmacokinetic parameters need to estimated for Endogenous substances are Cmax, AUC0-t and AUC0-inf. Bioequivalence criteria need to evaluated for Cmax, AUC0-t and AUC0-inf. FDA will not usually accept, if you submit AUC0-inf data only as supportive evidence excluding from Bioequivalence criteria.
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Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- Bioequivalence criteria for endogenous drug pash413 2012-02-03 12:15 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioequivalence criteria for endogenous drugdrgunasakaran1 2012-02-04 05:31
Ing. Helmut Schütz