Bioequivalence and Bioavailability Forum

IVIV (no C) [Design Issues]

posted by Helmut  – Vienna, Austria, 2011-01-18 12:11 (5633 d 01:52 ago) – Posting: # 6440
Views: 5,646

Dear Dan!

❝ According to CPMP/QWP/EWP/1401/98 Rev. 1: "In the event that the results of

❝ comparative in vitro dissolution of the biobatches do not reflect bioequivalence

❝ as demonstrated in vivo the latter prevails."

The next sentence is:
"However, possible reasons for the discrepancy should be addressed and justified."
(my emphases)

Justify:

1. To provide an acceptable explanation for.
   
2. To be a good, acceptable reason for.

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


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Science Quotes

Complete thread:

• Drug X BE study rahul dixit 2011-01-14 09:00 
  • Drug X BE study Dr_Dan 2011-01-14 14:57
    • Drug X BE study rahul dixit 2011-01-15 07:53
      • Drug X BE study Dr_Dan 2011-01-17 14:59
        • Drug X BE study rahul dixit 2011-01-18 06:00
          • Drug X BE study Dr_Dan 2011-01-18 09:40
            • IVIV (no C)Helmut 2011-01-18 11:11
              • IVIV (no C) Dr_Dan 2011-01-18 11:55
                • IVIV (maybe C) Helmut 2011-01-18 15:23
                  • IVIV (maybe C) rahul dixit 2011-01-19 05:14
                    • IVIV (maybe C) Dr_Dan 2011-01-19 10:07
                    • Posture Helmut 2011-01-19 10:52
                      • Posture rahul dixit 2011-01-19 13:28