ryraman2661
☆    

India,
2023-05-15 15:03
(394 d 21:00 ago)

Posting: # 23554
Views: 1,832
 

 Design for the EMA [Regulatives / Guidelines]

Dear Members,

I have one point to be discussed in the forum.

For Bioequivalence studies for EU submission, can we compare capsules VS tablets of same drug, and same strength.

If yes, whether both Cmax and AUC (total) to be included in the criteria? or we can compare only AUC (total).
What are the others points to be taken care.

Members can give their opinion.

Thanks

Raman
Chennai


Edit: Subject line changed; see also this post #2. [Helmut]
Helmut
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Vienna, Austria,
2023-05-15 15:40
(394 d 20:23 ago)

@ ryraman2661
Posting: # 23556
Views: 1,533
 

 BE for the EMA

Hi Raman,

❝ For Bioequivalence studies for EU submission, can we compare capsules VS tablets of same drug, and same strength.


Yes (see the applicable guideline about ‘pharmaceutical alternatives’).

❝ If yes, whether both Cmax and AUC (total) to be included in the criteria?


What do you mean by ‘AUC (total)’? You need to demonstrate BE for Cmax and AUC0-tlast (alternatively AUC0-72).

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ryraman2661
☆    

India,
2023-05-16 10:04
(394 d 01:59 ago)

@ Helmut
Posting: # 23558
Views: 1,545
 

 BE for the EMA

Thanks Mr. Helmet


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut] ≠ Helmet
Ohlbe
★★★

France,
2023-05-16 10:51
(394 d 01:12 ago)

@ Helmut
Posting: # 23559
Views: 1,493
 

 BE for the EMA

Dear Raman,

❝ ❝ For Bioequivalence studies for EU submission, can we compare capsules VS tablets of same drug, and same strength.


❝ Yes (see the applicable guideline about ‘pharmaceutical alternatives’).


... but only for immediate release products. Not for modified release. See section 1.2 of the guideline and article 10(2)(b) of Directive 2001/83/EC.

Regards
Ohlbe
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