Bioequivalence and Bioavailability Forum • Design for the EMA

ryraman2661
☆

India,
2023-05-15 15:03
(514 d 07:59 ago)

Posting: # 23554
Views: 2,409

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
★★★

Vienna, Austria,
2023-05-15 15:40
(514 d 07:22 ago)

@ ryraman2661
Posting: # 23556
Views: 2,014

BE for the EMA

Post reply

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 C_max and AUC_0-tlast (alternatively AUC_0-72).

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

ryraman2661 ☆ India, 2023-05-16 10:04 (513 d 12:58 ago) @ Helmut Posting: # 23558 Views: 2,007	BE for the EMA Post reply
	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 (513 d 12:11 ago) @ Helmut Posting: # 23559 Views: 1,958	BE for the EMA Post reply
	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