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95% UB criteria for FDA [Regulatives / Guidelines]

posted by sudy - India, 2018-07-11 12:31  - Posting: # 19032
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Hi all,

I have a query regarding acceptance criteria for RSABE as per FDA guideline.
As per progesterone guidance and FDA statistical guideline, 95% uppper confidence bound should be less than or equal to zero. Now,
1) less than zero mean negative value, it’s very clear.
2) Equal to zero, i have a doubt that it is exactly zero. Because in practical situation during statistical calculation, we never get exact zero (very less chance).

So if we have a value e.g. 0.01 or 0.001 or 0.06, If we round this value we get zero.
Can we consider it as zero? What FDA stands for this?

FDA given clarity for 90% confidence interval but not for 95% upper confidence bound.
Is there any reference to report value upto 2 digits after decimal place without rounding for 95% upper bound?

If anyone has any experience on this please share.

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