Posted by ed_uk2010 on October 3, 2010, at 16:13:35
In reply to Re: The Brand Vs. Generic.. Myth? » Brainbeard, posted by Conundrum on October 3, 2010, at 15:26:49
>I think there can be around 15% difference in the amount of the drug in the U.S.
That is not the case in any country! The amount of drug present in the tablet has to be exactly the same. No generic would be allowed to contain 15% less medication in the tablet, that would be ridiculous!
New generics are tested for bioequivalence to the brand leader. The criteria used by the FDA are similar to the criteria used in Europe.
In general, to establish bioequivalence, the calculated 90% confidence intervals for the AUC and Cmax should fall within the range 80% to 125%. Tighter limits are required for certain drugs. The 80% to 125% range is part of a statistical calculation, it does not mean that the generic is permitted to be 20% less bioavailable. The manufacturer will submit graphs of plasma level versus time for their product versus the brand leader.
Most studies of new generics reveal extremely similar bioavailability to the brand leader. Differences are more likely for sustained release products compared with standard release medicines.
poster:ed_uk2010
thread:963707
URL: http://www.dr-bob.org/babble/20100926/msgs/964598.html