Bioequivalence and Bioavailability Forum

EMA and similar regulations… [Bioanalytics]

posted by Helmut  – Vienna, Austria, 2014-11-28 20:16 (3834 d 01:40 ago) – Posting: # 13955
Views: 13,963

Hi Angus,

agree with everything you wrote. On this side of the pond common sense is (no more) the driving force behind (some) regulations. Repeating samples for PK reasons is not acceptable over here. A single value can screw up an entire study.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 07:25 
  • Handling "Not Reportable" Data ElMaestro 2014-11-21 07:34
    • Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 07:54
      • Handling "Not Reportable" Data nobody 2014-11-21 08:07
        • Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 08:18
          • Handling "Not Reportable" Data ElMaestro 2014-11-21 09:53
          • Handling "Not Reportable" Data nobody 2014-11-21 11:11
            • Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 16:14
              • IS carry-over? Helmut 2014-11-21 16:45
                • IS carry-over? nobody 2014-11-21 17:19
                • IS carry-over? Emrah Soner Özdeş 2014-11-24 08:58
                • IS carry-over? Emrah Soner Özdeş 2014-11-27 10:28
                  • Another story! Helmut 2014-11-27 14:21
                    • Another story! Emrah Soner Özdeş 2014-11-28 10:00
                    • Another story! nobody 2014-11-28 10:18
      • Handling "Not Reportable" Data AngusMcLean 2014-11-28 19:09
        • EMA and similar regulations…Helmut 2014-11-28 19:16
          • EMA and similar regulations… jag009 2014-12-01 19:54