Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by Dr_Dan  – 2020-03-11 11:47 (500 d 12:49 ago) – Posting: # 21240
Views: 3,544

Hello ping4santosh,
Even if you aim at substitution indication (improvement of patient's compliance) presenting co-prescription data and therapeutic guidelines recommending the co-administration will not suffice as long as you are unable to present clinical data demonstrating safety and efficacy of the respective combination. IMHO it will be hard to identify a new FDC which can be approved without a phase III study (at least in western Europe).

Kind regards and have a nice day
Dr_Dan

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