Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-03-11 14:24 (266 d 23:41 ago) – Posting: # 21246
Views: 3,174

Dear SKM,

First of all: please follow the forum policy. See also this post #5. The forum administrators and moderators had to edit each and every one of your response messages. Persistent non-compliance may result in your account being blocked without further notice.

» Awaiting your thoughtful response!

We all post in our free time. See also also this post #9. To quote it: A reasonable waiting period is two weeks or if the thread has left the entry page of the forum. If you're in a hurry: hire a consultant.

» The dosing frequency for both the product is just one time treatment.

One-time antipyretic :confused:

» When we have both the product similar in it's posology, why do we need two pricks? Won't it suffice as the rationale of FDC?

Nope. Please read the guidance I pointed to you. Again, the "comfort" part is not sufficient if these are not two existing active principles which are always to be administered together, and this combination is written in both SmPC. So why this particular antipyretic, while there are so many on the market ? Why give an antipyretic SC or IM ? Many antipyretics are available as solutions or suspensions for patients who have difficulties swallowing tablets. If the subject is unable to swallow anything: he'll have an IV line and will be able to receive antipyretics available for IV administration, so no extra prick anyway.

» I don't see any reason for safety and efficacy study requirement.

Drug A may have an acceptable tolerability when administered alone. Drug B may have an acceptable tolerability when administered alone. It doesn't mean that if you inject drug A + drug B together at the same injection site, + some solubiliser not contained by drug A and drug B in their marketed formulations, you will still have an acceptable tolerability, particularly at the injection site.

Regards
Ohlbe

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