Widening Cmax in EU [RSABE / ABEL]

posted by drgunasakaran1  – 2013-10-24 17:43 (4220 d 04:45 ago) – Posting: # 11751
Views: 4,853

Dear Clarc,

❝ Can I define in the protocol a widening to 0.75-1.33, or I have to perform a reference scaled bioequivalence?


For EU submission, it is suggested to go for Expandable BE limits as per EMA's Guideline on the Investigation of Bioequivalence
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

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