Bioequivalence and Bioavailability Forum

Tricky… [RSABE / ABEL]

posted by Helmut  – Vienna, Austria, 2020-01-30 20:18 (1544 d 18:48 ago) – Posting: # 21112
Views: 19,898

Salam Osama,

❝ ❝ […] with fixed (!) limits of 75.00–133.33% if CV_wR <30%.

❝

❝ I think there is a mistake here, you are right according to the fixed limit of 75-133% in the GCC Guidelines in the case of HVD (HVDP) which is absolutely not correct and cause a lot of problems in the evaluation of such drug formulation's types, BUT widen to this range is not in the case of ABE and not at all if CVwR <30% .

Of course, of course! Sorry, it was a stupid typing error.

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


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• Statistical evaluation and BE hypo­theses in full replicate design Elena777 2020-01-28 07:02 
  • Inflation of the TIE as well Helmut 2020-01-29 15:38
    • Inflation of the TIE as well Elena777 2020-01-29 20:01
      • Tricky… Helmut 2020-01-30 12:07
        • Tricky… Mikalai 2020-01-30 13:08
          • Terrible… Helmut 2020-01-30 15:09
            • Tricky… Mikalai 2020-01-30 16:02
              • Deep shit Helmut 2020-01-30 16:59
                • Deep shit Mikalai 2020-01-30 18:39
                  • Deep shit Mikalai 2020-01-30 19:31
                  • Deep shit Helmut 2020-01-30 20:07
                    • Deep shit Mikalai 2020-01-31 11:14
                      • Deep shit Helmut 2020-01-31 14:00
                        • Deep shit Mikalai 2020-01-31 16:07
          • Flawed evaluation accepted Helmut 2020-01-31 12:19
            • Flawed evaluation accepted Mikalai 2020-01-31 12:40
              • Flawed evaluation accepted Helmut 2020-01-31 14:17
                • Flawed evaluation accepted Mikalai 2020-01-31 16:41
                  • Flawed approach even if accepted ? Helmut 2020-01-31 20:28
                    • Flawed approach even if accepted ? Mikalai 2020-02-01 16:18
                      • misunderstanding mittyri 2020-02-01 21:34
                        • misunderstanding Mikalai 2020-02-06 13:41
                          • misunderstanding mittyri 2020-02-06 16:23
                      • The globe is flat! d_labes 2020-02-05 19:16
        • Tricky… wienui 2020-01-30 18:53
          • Tricky…Helmut 2020-01-30 19:18
            • Tricky… wienui 2020-02-03 07:10
              • ABE vs. ABEL Helmut 2020-02-03 12:25
                • zigzag d_labes 2020-02-05 18:53
                  • zigzag Helmut 2020-02-05 19:46
                    • zigzag Mikalai 2020-02-06 11:38
                      • helter-skelter Helmut 2020-02-06 20:12
                        • helter-skelter Mikalai 2020-02-10 16:10
    • Inflation of the TIE as well zizou 2020-02-01 17:00
      • Inflation of the TIE as well nobody 2020-02-01 23:30
    • Inflation of the TIE as well Elena777 2020-03-10 19:28
      • Fishing in the dark Helmut 2020-03-10 21:06
  • Statistical evaluation and BE hypo­theses in full replicate design nobody 2020-02-03 15:07
    • TIE, repeat once more please... Astea 2020-04-02 12:41