BE study design question [Design Issues]

posted by jag009  – NJ, 2012-04-17 23:42 (5182 d 19:01 ago) – Posting: # 8437
Views: 3,259

Hi everyone,

If a product is labeled as "can be chewed or swallowed as a tablet". The generic BE program should include two SD studies:

1) Test (swallowed) vs Ref (swallowed)
2) Test: Chewed vs Swallowed

Correct?

Thanks

John

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