Evaluation of Reference variability [Design Issues]

posted by Nirali  – India, 2009-04-17 09:38 (5460 d 07:10 ago) – Posting: # 3551
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Thank you friends.

Actually, we got the proposal to evaluate reference variability using below design:
"2-period replicate design to assess the intra-subject variability of reference drug, in which reference drug given in both the periods".

Shall it be appropriate design to evaluate reference variability for EU regulatory? :confused:

Regards,
NIRALI

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