Bioequivalence and Bioavailability Forum • Correction to EMA Final BE-GL

Helmut
★★★

Vienna, Austria,
2010-03-28 19:28
(5563 d 02:07 ago)

Posting: # 4978
Views: 4,262

Correction to EMA Final BE-GL [Regulatives / Guidelines]

Dear all,

a correction (dated 10 March 2010) was published recently. The new Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1/Corr

Changes (apart from a few typos):
p10, 4^th paragraph: 'kcal' instead of 'calories' ;-)

p15, 5^th paragraph: In specific cases of products with a narrow therapeutic range, the acceptance interval ~~for AUC~~ may need to be tightened (see section 4.1.9).

—
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

yjlee168 ★★★ Kaohsiung, Taiwan, 2010-03-29 15:36 (5562 d 05:59 ago) @ Helmut Posting: # 4980 Views: 3,287	Correction to EMA Final BE-GL Post reply
	Dear Helmut, Thank you for your information. So it is just for the "immediate release dosage forms with systemic action" (page 4/27)of EXECUTIVE SUMMARY? — All the best, -- Yung-jin Lee bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee Kaohsiung, Taiwan https://www.pkpd168.com/bear Download link (updated) -> here

Helmut
★★★

Vienna, Austria,
2010-03-29 15:47
(5562 d 05:48 ago)

@ yjlee168
Posting: # 4982
Views: 3,271

Correction to EMA Final BE-GL

Post reply

Dear Yung-jin!

❝ So it is just for the "immediate release dosage forms with systemic action"

Are you trying to confuse me? Yes, this guideline deals with immediate release formulations only. Or do you mean the 'standard meal', which is not a high fat, high calory meal like in 1999's MR-guideline? That's intentional.

—
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

yjlee168
★★★

Kaohsiung, Taiwan,
2010-03-29 15:55
(5562 d 05:39 ago)

@ Helmut
Posting: # 4984
Views: 3,282

Correction to EMA Final BE-GL (for IR dosage forms)

Post reply

Dear Helmut,

❝ :confused: Are you trying to confuse me? Yes, this guideline deals with immediate release formulations only. Or do you mean the 'standard meal', which is not a high fat, high calory meal like in 1999's MR-guideline? That's intentional.

Sorry about this. I just like to emphasize that this guideline is only for IR. Nothing else. Thanks.

—
All the best,
-- Yung-jin Lee
bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here