Restriction on widened limit -AUC of HVD [RSABE / ABEL]

posted by ashokraj – India, 2015-07-22 16:26 (3996 d 13:54 ago) – Posting: # 15124
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Hi all

Can any one through some light on why EMA do not allow widening of CI limits for AUC of HVDs? Whereas RSABE is applicable for AUC as well by USFDA.

rgds/Ashokraj

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