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Hormone Therapy - Preliminary Report

 
 
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Old 03-14-2012, 09:16 AM #23
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mrsD mrsD is offline
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mrsD mrsD is offline
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Join Date: Aug 2006
Location: Great Lakes
Posts: 33,508
15 yr Member
Lightbulb
That 85% comes up over and over! It is a mathematical % and
not a comparison %.

It has to due with area under the curve, in logarithmic numbers.

It does NOT mean 85% of the parent compound per dose.

It is on the FDA website.
http://www.fda.gov/Drugs/Development.../ucm079068.htm
Quote:
The primary concern from the regulatory point of view is the protection of the patient against approval of products that are not bioequivalent. The current practice of carrying out two one-sided tests at the 0.05 level of significance ensures that there is no more than a 5% chance that a generic product that is not truly equivalent to the reference will be approved.
It is explained there, for those who understand math.

But this 85% (mostly in relation to opiates), is a misquote of a concept not well understood by laymen, or doctors.
Scroll down to "statistical criteria of bioequivalence"
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