Pharmacokinetics linearity [Regulatives / Guidelines]
Dear PJS
Honestly, I do not understand your question. The originator demonstrated linearity after i.v. and oral administration (irrespectively of formulation type tablet or solution). I guess you develop an oral solution formulation whereas the originator is a solid oral formulation. In this case your formulation is no generic. In order to make reference to the originator´s dossier in a mixed application you need to show bioequivalence of your oral solution formulation against the solid oral formulation. Since the drug is a BCS class III substance it will become hard to achieve equivalence in terms of AUC and Cmax using the same strength. Good luck! I guess you will need a clinical study in order to demonstrate safety and efficacy.
I hope this helps.
Kind regards
Dr_Dan
Honestly, I do not understand your question. The originator demonstrated linearity after i.v. and oral administration (irrespectively of formulation type tablet or solution). I guess you develop an oral solution formulation whereas the originator is a solid oral formulation. In this case your formulation is no generic. In order to make reference to the originator´s dossier in a mixed application you need to show bioequivalence of your oral solution formulation against the solid oral formulation. Since the drug is a BCS class III substance it will become hard to achieve equivalence in terms of AUC and Cmax using the same strength. Good luck! I guess you will need a clinical study in order to demonstrate safety and efficacy.
I hope this helps.
Kind regards
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Pharmacokinetics linearity pjs 2015-05-20 10:25 [Regulatives / Guidelines]
- Pharmacokinetics linearity pjs 2015-05-28 12:26
- Pharmacokinetics linearity nobody 2015-05-28 13:44
- Pharmacokinetics linearity ElMaestro 2015-05-28 14:14
- Pharmacokinetics linearityDr_Dan 2015-05-28 14:32
- Pharmacokinetics linearity pjs 2015-05-28 14:58
- Pharmacokinetics linearity nobody 2015-05-28 15:50
- Pharmacokinetics linearity pjs 2015-05-28 16:11
- Pharmacokinetics linearity Dr_Dan 2015-05-29 09:03
- Pharmacokinetics linearity pjs 2015-05-28 16:11
- Pharmacokinetics linearity nobody 2015-05-28 15:50
- Pharmacokinetics linearity pjs 2015-05-28 14:58
- Pharmacokinetics linearityDr_Dan 2015-05-28 14:32
- Pharmacokinetics linearity ElMaestro 2015-05-28 14:14
- Pharmacokinetics linearity nobody 2015-05-28 13:44
- Pharmacokinetics linearity pjs 2015-05-28 12:26