Bioequivalence and Bioavailability Forum • BE Study Appropriate or not for I.M formulation

Neo
☆

2012-01-03 13:55
(5287 d 16:18 ago)

(edited on 2012-01-03 15:19)
Posting: # 7856
Views: 3,095

BE Study Appropriate or not for I.M formulation [Regulatives / Guidelines]

Dear Members,

I need an opinion on the following situation.

Parenteral Innovator product (Active ingredient A, Excipients B, C, D).
Parenteral New formulation (Active ingredient A, Excipients B, C, F).

Both Innovator and new formulation are intended for same ROA (I.M), have same active ingredient salt and are for same indication.

The differences are:

Innovator inj has X mg of active ingredient (A) in total injection volume of 3ml. New formulation also has X mg of active ingredient (A) but in total injectable volume of 2mL.
The new formulation replaces an excipient D of Innovator product, with another excipient F. F has documented use as excipient in pharmaceutical preparations in other approved products in EU member states.

Pilot BE has shown bioequivalence of the products.

Question is will a pivotal BE study be sufficient for getting marketing authorization or any additional clinical studies are needed, with special reference to EU..

Thanks in advance,
Neo

Neo
☆

2012-01-06 11:53
(5284 d 18:20 ago)

@ Neo
Posting: # 7874
Views: 2,506

BE Study Appropriate or not for I.M formulation

Post reply

Dear Helmut,

As I am new to this forum, I am slightly confused as to whether my previous querry on BE study for an IM formulation, has been posted properly so that it is viewable by the members. I have seen that your kindself and most members reply very promptly to new posts and the answers are very informative. Pls let me know if I need to follow additional steps to post my querry / expect a reply.

Regards,
Neo

Helmut
★★★

Vienna, Austria,
2012-01-06 14:30
(5284 d 15:44 ago)

@ Neo
Posting: # 7876
Views: 2,469

‘Fast’ replies

Post reply

Dear Neo,

welcome to the forum!

❝ I am slightly confused as to whether my previous querry […] has been posted properly so that it is viewable by the members.

No worries; if you can see it others see it as well.

❝ I have seen that your kindself and most members reply very promptly to new posts and the answers are very informative. Pls let me know if I need to follow additional steps to post my querry / expect a reply.

See here. We are posting in our spare time. I’m afraid that sometimes a question (like yours) is not trivial and can’t be answered in a quickshot. Since you are targeting EMA, many regular European posters are still on holidays and didn’t visit the forum in the past ~10 days. Please be patient – sooner or later you can expect a reply. THX for understanding.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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