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Konrad Kulak

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United States

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1 to 5 of 24 total

FDA guide on number of animals for PK study

Posted By Konrad Kulak 02-Jan-2019 13:00
Found In Egroup: Regulatory Open Forum \ view thread
​Hi All, I was wondering what FDA guide points to the number of animals for PK study - I think there is a minimum of 3-4 animals per time point - is it correct? Thank you, Konrad ------------------------------ Konrad Kulak Frederick MD ------------------------------

RE: FDA software approval for sample size calculation

Posted By Konrad Kulak 04-Sep-2018 03:47
Found In Egroup: Regulatory Open Forum \ view thread
​Thank you, Yes, the point is whether the computational algorithms / softwares were validated. Thank you again, Konrad ------------------------------ Konrad Kulak Frederick MD ------------------------------

FDA software approval for sample size calculation

Posted By Konrad Kulak 01-Sep-2018 09:37
Found In Egroup: Regulatory Open Forum \ view thread
Hi All, I was wondering if FDA has any preference to what statistical software is used for sample size estimation? Thank you, Konrad ------------------------------ Konrad Kulak Frederick MD ------------------------------

RE: RAC US -Fall 2018

Posted By Konrad Kulak 19-Jul-2018 03:43
Found In Egroup: Regulatory Open Forum \ view thread
​Hi, I forgot to add my email konradkk@yahoo.com and my skype koni.koni Thank you, Konrad ------------------------------ Konrad Kulak Frederick MD ------------------------------

RE: RAC US -Fall 2018

Posted By Konrad Kulak 18-Jul-2018 11:03
Found In Egroup: Regulatory Open Forum \ view thread
​Hi All, I am interested as well, if it is not too late. Thank you, Konrad ------------------------------ Konrad Kulak Frederick MD ------------------------------