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ICH stability requirements - Absolute values+ Standard Deviation Calculations

  • 1.  ICH stability requirements - Absolute values+ Standard Deviation Calculations

    Posted 13-Nov-2013 10:39

    Hi,
    Does anybody know if there are any specific requirements in the ICH guidelines with regards to provision of data for Absolute Values and Standard Deviation Calculation to support stability studies?
    Thanks!
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    Ana De Andres Gomez PHD
    Astrazeneca
    Macclesfield
    United Kingdom
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  • 2.  RE:ICH stability requirements - Absolute values+ Standard Deviation Calculations

    Posted 13-Nov-2013 11:43
    Please refer to the 2nd document at http://wp.me/P33LGu-1To

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    President and Principal
    http://www.regulatorydoctor.com
    Riner VA
    United States
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