Posted by ed_uk2010 on November 20, 2011, at 14:42:58
In reply to Re: 2nd MAOI after the first one failed? » ed_uk2010, posted by europerep on November 20, 2011, at 14:17:34
>Throw together any combination of those substances and you are free to sell it.
That would not be good at all! The bioavailability could be changed if the composition of the tablet was altered.
>I didn't know that preparations (and not just the active drugs they contain) had to be approved too.
Yes, everything has to be approved. The composition of the tablet, the manufacturing site, the manufacturing process, the packaging etc. For example, if a company is launching a generic version of a product, they may choose to use some different ingredients (for example a different colouring). They will need to do tests to show that the drug is still absorbed from the tablet in the same way.
If Archimedes wanted to change the ingredients in Nardil, they would have to get approval for all of the changes. They would have to do studies to show that the tablets still dissolve the same way, that the new tablet manufacturing process is appropriate and that the phenelzine is still absorbed into the body at the same rate and in the same quantity. All this would cost money. For a low volume product which is only distributed to a few large wholesalers, why bother?
I noticed that Archimedes UK don't even mention Nardil on their website. Hmm, that's not too encouraging.
poster:ed_uk2010
thread:990065
URL: http://www.dr-bob.org/babble/20111120/msgs/1003227.html