Bioequivalence and Bioavailability Forum

FDA: antique of ’93 [Regulatives / Guidelines]

posted by Beholder  – Russia, 2018-06-21 11:21 (1922 d 23:35 ago) – Posting: # 18936
Views: 8,473

Hi Helmut and all!

❝ Now I know where the Europeans copypasted from.

I went through the forum but still could not find the information. Ok, we know that it is "highly likely" () that the EMA took "1/10 or 100,000 rule" from FDA. But why did FDA deside to use 1/10 or 100,000 rule? Why not, for instance, "1/15 and 150,000" or 100,000 is just round number and that's all?

Thank you in advance

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 ’93 Helmut 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 ’93Beholder 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