Regulatory Open Forum

 View Only

  • 1.  Simplified ts.xpt Files

    Posted 06-Dec-2021 11:35
    Hello,

    Has anyone created a simplified ts.xpt file and had it successfully transmitted through the ESG?  We have not be able to get one to upload.  It passes our own validation but will not pass FDA's.

    Regards,
    Ken

    ------------------------------
    Ken Rose
    Painesville OH
    United States
    ------------------------------


  • 2.  RE: Simplified ts.xpt Files

    Posted 07-Dec-2021 08:09
    Hi Ken - I have successfully submitted them but have always had the lab create them. Probably for the simple reason that I have spent too many hours in my life dealing with creation of these kinds of files, such as SPL. Good luck.

    ------------------------------
    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
    ------------------------------

    Original Message


  • 3.  RE: Simplified ts.xpt Files

    Posted 08-Dec-2021 16:41
    Thank you Glen.

    Ken

    ------------------------------
    Ken Rose
    Painesville OH
    United States
    ------------------------------

    Original Message


  • 4.  RE: Simplified ts.xpt Files

    Posted 07-Dec-2021 08:33
    Hi Ken, if you are following the FDA guide on generating this dataset I suggest using R rather than Python.  Following the FDA provided guide and using R it is quite simple to create compliant Simplified TS datasets.

    ------------------------------
    Stephen Sullivan
    Assoc Director, Regulatory Operations
    Melrose MA
    United States
    ------------------------------

    Original Message


  • 5.  RE: Simplified ts.xpt Files

    Posted 08-Dec-2021 16:41
    Thank you Stephen, we'll give that a try.
    Ken

    ------------------------------
    Ken Rose
    Painesville OH
    United States
    ------------------------------

    Original Message


Related Content