Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-06 10:21 (1507 d 06:07 ago) – Posting: # 21215
Views: 6,540

Hello Friends,

I am struggling with a project to find out the studies that we would require to register a fixed dose combination product in EU.

Basically we are trying to combine two different injections (One antibiotic and one antipyretic). Both the products are registered as individual API injection in EU. One product requires high pH for solubility and another is low pH. In order to combine these two that are stable at two different pH, we have added a stabilizer. Technically, it is feasible to combine both injections to make it one injection.

As we know, we don't need to do BA/BE study in case of Immediate release products to register the generic versions, can we extend the similar logic to a Fixed Dose Combination of two Immediate release products that are individually registered and we don't need to do any in-vivo studies?

Do we need to do any In-vivo study? If yes, what all do we need to do? Do we also need safety studies along with BA/BE? Do we need to do efficacy too?

Please help me with your inputs.

Thanks a lot in advance.
Best regards
SKM

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