Forced degradation studies

[mk12]

My boss asked to me perform forced degradatioin study on one of our drug candidate..I have not done it before..please advise ...send me link of some article where I can get information how to start

[tom jupille]

http://www.aapspharmaceutica.com/meetin ... ements.pdf

[Bruce Hamilton]

Most of the ICH documents mentioned in the presentation are freely available at www.ich.org in the Guidelines / quality section.

Just ensure that, if you plan to provide the data to regulators or clients, your Quality group has approved the experimental plan before you start.

Bruce Hamilton

[Dan]

You can also search this forum for some discussions on this topic.

Here's one example:

http://www.sepsci.com/chromforum/viewtopic.php?t=8017

Regards,
Dan