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Stability ICH Q1E

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

Re: Stability ICH Q1E

This is the paper, rather than the link.

Re: Stability ICH Q1E

Hey Byron,

 

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

 

Thanks for the article.

 

Chris

Re: Stability ICH Q1E

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.

Re: Stability ICH Q1E

Paper with current thinking on product stability.  Some good ideas to keep in mind when talking about stability studies with customers.

 

http://download.springer.com/static/pdf/889/art%253A10.1186%252Fs41120-017-0011-z.pdf?originUrl=http%3A%2F%2Flink.springer.com%2Farticle%2F10.1186%2Fs41120-017-0011-z&token2=exp=1485182697~acl=%2Fstatic%2Fpdf%2F889%2Fart%25253A10.1186%25252Fs41120-017-0011-z.pdf%3ForiginUrl%3Dhttp%253A%252F%252Flink.springer.com%252Farticle%252F10.1186%252Fs41120-017-0011-z*~hmac=6feed2c71469eb915003ef635de0bb6164fa8915b601d91c3eb830f06eb99881

Re: Stability ICH Q1E

Hi Don,

That is great. I think that should be enough to satisfy the customer.

Thanks,

Phil

Re: Stability ICH Q1E

Phil,

Here's a link to ICH Q1E: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1E/Step4/Q1E_Guideline.pdf. Section B.2.2.1 outlines the use of ANCOVA and the 0.25 test for slopes.

Don