Bioequivalence and Bioavailability Forum

FDA: antique of ’93 [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2013-12-11 00:32 (3640 d 10:17 ago) – Posting: # 12033
Views: 10,811

Hi John,

❝ See page 2 of FDA Guidance I know it's old...

Oh boy, I completely have forgotten this one!
Now I know where the Europeans copypasted from. Nothing was stated in the ’91 version. Appeared for the first time in the ’98 draft and was carried over ever since.

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


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Complete thread:

• FDA: Size of bio-batch Helmut 2013-12-10 14:05 [Regulatives / Guidelines] 
  • FDA: Size of bio-batch jag009 2013-12-10 20:03
    • FDA: antique of ’93Helmut 2013-12-10 23:32
      • FDA: antique of ’93 jag009 2013-12-11 15:23
        • FDA: antique of ’93 Helmut 2013-12-11 15:26
          • FDA: antique of ’93 jag009 2013-12-11 16:21
            • FDA: antique of ’93 Helmut 2013-12-11 16:29
              • FDA: antique of ’93 jag009 2013-12-11 23:16
                • Patience Helmut 2013-12-12 14:34
      • FDA: antique of ’93 Beholder 2018-06-21 09:21
        • Nice numbers Helmut 2018-06-21 15:05
          • Nice numbers Beholder 2018-06-22 10:33
            • Type II variation Helmut 2018-06-22 15:12
        • Birdsong's third law of BE ElMaestro 2018-06-22 10:10
          • Experience Beholder 2018-06-22 11:04
            • Why, oh why? Helmut 2018-06-22 15:17
              • Sorry for the delay Beholder 2018-10-18 09:40