Pharmacokinetics linearity [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2015-05-28 16:32 (3543 d 16:13 ago) – Posting: # 14868
Views: 4,466

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

Kind regards and have a nice day
Dr_Dan

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