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  • 1.  FDA software approval for sample size calculation

    Posted 01-Sep-2018 09:37
    Hi All,
    I was wondering if FDA has any preference to what statistical software is used for sample size estimation?
    Thank you,
    Konrad

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    Konrad Kulak
    Frederick MD
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  • 2.  RE: FDA software approval for sample size calculation

    Posted 02-Sep-2018 04:10
    I do not think that FDA will ever come and stating a preferred statistical software package they would use, but there are commercial software that would do this fine like SAS or Minitab.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: FDA software approval for sample size calculation

    Posted 03-Sep-2018 20:26
    FDA does not have a preferred method.  I can recommend nQuery by Stat Solutions for binary, continuous, and time to event endpoints.  SAS is good for simulations.  NQuery can handle superiority, non-inferiority (NI), and my quasi-NI designs for one sample and two sample situations.  NQuery also has a Bayes package.  Both nQuery and SAS are validated.  There are also many on-line options but these often lack details whether the computational algorithms have been validated. 


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    Phil Lavin PhD, FASA, FRAPS
    Principal
    Lavin Consulting LLC
    Framingham MA 01702 USA
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    Original Message


  • 4.  RE: FDA software approval for sample size calculation

    Posted 04-Sep-2018 07:47
    ​Thank you,
    Yes, the point is whether the computational algorithms / softwares were validated.
    Thank you again,
    Konrad


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    Konrad Kulak
    Frederick MD
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    Original Message


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