Re: Generics » ed_uk

Posted by SLS on January 6, 2007, at 18:14:59

In reply to Generics » linkadge, posted by ed_uk on January 6, 2007, at 16:45:45

> Product A = the test product ie. the new generic
> Product B = the reference product ie. the original brand
>
> A 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.

Go get your Ph.D. and be done with it.

- Scott

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