Print

Print


In a message dated 97-10-22 09:56:11 EDT, you write:

I presume Dr. Olanow is speaking metaphorically- that there are elements of
the action of selegiline that will lead to the discovery of "the ideal agent"
 not that the ideal agent is chemically in the current
formulation. It certainly is unclear from your quote though.

and

<< new work that they have done shows that Selegiline is metabolised to
des-methyl selegiline and  that entity is what provides the protective
component >>


Selegiline is a synthetic substance and if indeed the des-Me-selegiline is
the bioactive metabolite doing the protective work, why not just provide the
demethylated substance itself in a dosage form instead of making the body do
the work?

The bulk substance and the dosage forms of Selegiline was approved by the FDA
around 1990.  This means that the manufacturer had to prove the drug for
efficacy as well as for other physical and chemical attributes.  To that end,
the manufacturer  had to submit volumes of evidence.  When additional
evidence emerges, it becomes part of the drug submission.
After approval of the NDA, the USP provides the specifications for the drug
 and then verifies that the products  meets all these requirements.
Michel M.