Esomeprazole GR Capsules [Regulatives / Guidelines]

posted by Shuanghe  – Spain, 2014-06-27 16:40 (4384 d 07:51 ago) – Posting: # 13158
Views: 3,733

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

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