Reference Scaled Design [RSABE / ABEL]

posted by GSTATS Homepage – India, 2011-06-13 13:06 (5085 d 01:18 ago) – Posting: # 7113
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Dear RS,

❝ Please any one suggest what are the main differences of Analysis for EMEA and USFDA Reference Scaled Study.


I feel the main difference between the approaches recommended by EMA and FDA for reference scale study is the difference in regulatory constant used for scaling i.e For FDA swo=0.25 and for EMA swo=0.2936.

For complete disscussion on differences you should go through the thread given below:
Thread

Regards,
GSTATS

Let Noble Thoughts come from Every Side: RIG VEDA

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