Stability ICH Q1E

Question

Hi,

I know that the stability analysis in JMP follows ICH Q1E but I can't find any documentation to prove that for a customer.

The best I can find is an old JMP Newswire article that mentions it. The link to the video is broken.

JMP® Newswire | JMP

And a reference in the help to a 2007 book by Chow, which presumably references ICH Q1E?

Any ideas?

Thanks,

Phil

Byron_JMP · Answer

This is the paper, rather than the link.

analytical approaches.pdf

Chris_Kirchberg · Answer

Hey Byron,

The link does not appear to work unless one is connected via VPN.

Thanks for the article.

Chris

Mark_Bailey · Answer

BTW, we offer a one-day course about stability analysis with JMP. The Q1E and Q1A guidance documents are embedded in the training, too, as well as articles by industry action committees. It is available for on-site classes or as a recording for self-paced learning.