Posted by SLS on July 15, 2009, at 7:31:56
In reply to Re: Nortriptyline Generic or Brand Favorites?, posted by SLS on July 15, 2009, at 7:12:23
> I don't know what the answer is.
>
> The generic companies should probably be required to run clinical trials comparing their drug preparations using the original brand as a comparator. However, this might dissuade companies from investing the money to bring some drugs to market, especially the cheaper ones.Maybe the generic drugs can be subject to a large battery of tests not yet conceived that would obviate the need for clinical trials. The generic drugs would have to be subject to the same environment as exists in the digestive tract to see if there are interactions that result in chemical reactions between drug and excipients. I'm sure we can think of a bunch of tests, including extended pharmacokinetic trials using healthy volunteers rather than single-dose assays. I'm sure the technology for any of these things already exists. It is just a matter of the experts brainstorming what types of testing would be ideal to establish the sort of bioequivalence that would guarantee therapeutic equivalence.
- Scott
poster:SLS
thread:906750
URL: http://www.dr-bob.org/babble/20090709/msgs/906832.html