evaluation of stability test results

[Kaoula]

I know this is not directly related to HPLC analysis but I have a question regarding stability

It exist a reference which help me to evaluate the stability test result and use this results for determination the shelf life of drug product ??

Thank you
Kaoula

[KarenJ]

There is some helpful information about stability studies in ICH Guideline Q1A(R2), Stability Testing of New Drug Substances and Products.

http://www.ich.org/MediaServer.jser?@_ID=419&@_MODE=GLB

KarenJ

[Kaoula]

Hi KarenJ :
thank you for your advice but I need a practical approach to determine the shelf life of product using the stability test results
Thank you very match
Kaoula

[tom_mizukami]

As the guidance states the intersection of the one sided 95% confidence interval with the limit.

Chow, S. and Liu, J. (1995). Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability. New York: Marcel Dekker, Inc.

Here is an easy explanation:
http://www.causeweb.org/repository/Star ... y_testing/

Most larger pharmaceutical companies would surely use SAS or JMP in a validated environment. You may also want to check out SlimStat+ http://www.slim-stat.com/slimstatplus.htm

Good luck,

Tom

[JM]

Most of the shelf life predictions are based on assay values , how about Impurities and how to deal with them??

JM

[BenNC]

Same basic principle as with the assay except that you're watching the impurities approach the limit. You will likely exceed the limit that you set for individual or total impurities before you fall below the assay limit.