Log in
Register|
balakotu ★ India, 2014-06-27 14:24 (4385 d 12:55 ago) Posting: # 13155 Views: 4,649 |
|
|
Dear All, Please clarify, For “Esomeprazole Gastro Resistant Capsules 40 mg and 20 mg” what are the studies required for Europe? As a normal practice crossover fasting and fed studies on 40 mg and fasting study on 20 mg is sufficient? Need to conduct “multiple dose study on 40 mg” and “single dose fasting study on 20 mg”? Here reference product is “Esomeprazole Gastro Resistant Tablets 40 mg and 20 mg”, since innovator capsules are not available in Europe market. Regards Kotu. |
|
Mahesh M ★ India, 2014-06-27 16:38 (4385 d 10:41 ago) @ balakotu Posting: # 13157 Views: 3,775 |
|
|
Dear Kotu, As a normal practice crossover fasting and fed studies on 40 mg and fasting study on 20 mg is sufficient? Correct. ❝ Need to conduct “multiple dose study on 40 mg” and “single dose fasting study on 20 mg”? Multiple dose study is only required for prolonged release or Extended release dosage form so no need to do multiple dose study for the Esomeprazole GR capsule Regards Mahesh |
|
Shuanghe ★★ Spain, 2014-06-27 16:40 (4385 d 10:39 ago) @ balakotu Posting: # 13158 Views: 3,736 |
|
|
Hi Kotu, ❝ As a normal practice crossover fasting and fed studies on 40 mg and fasting study on 20 mg is sufficient? For EU submission I don't think you'll need BE study for 20mg strength. Assuming that your formulations are proportional if you can demonstrate that test is BE to Ref for 40mg strength under fasting and fed, I believe you can request biowaiver for 20mg. — All the best, Shuanghe |
Ing. Helmut Schütz