Posted by ed_uk on January 6, 2007, at 16:45:45
In reply to +/- 20% really sucks, posted by linkadge on January 6, 2007, at 15:09:15
Hi Link,
>So, generics are allowed to be as much off as +/- 20%?
>If you were taking 375mg of effexor, you could have as much as much as 150mg difference between two doses.
No, the amount of drug in a generic tablet/cap will be almost identical to the amount of drug in a branded tablet/cap. When comparing a new generic product to the orginal branded product, bioequivalence studies are performed. In the UK, the following criteria are assessed:
Product A = the test product ie. the new generic
Product B = the reference product ie. the original brandA group of volunteers are given the medication. Pharmacokinetic parameters (AUC, Cmax and Tmax) are determined for each product (A and B). The ratio of A/B for AUC and Cmax and 90% geometric confidence intervals for AUC and Cmax respectively are determined. These values must fall within the accepted regulatory range of 80-125% (0.80-1.25 range) to indicate that A is bioequivalent to B.
Ed
poster:ed_uk
thread:719885
URL: http://www.dr-bob.org/babble/20070101/msgs/719916.html