Bioequivalence and Bioavailability Forum

Partial replicate design & ABE for the FDA [Design Issues]

posted by Helmut  – Vienna, Austria, 2017-03-06 15:00 (3393 d 20:36 ago) – Posting: # 17140
Views: 13,914

Hi nobody,

❝ One guy told me: I'm not going to determine any parameter that is

❝

❝ a - not asked for by authorities

Good advice. I have given up reporting anything (even in an exploratory manner) which is not requested.

❝ b - might put my product (now or in the furture...) in a bad light compared to reference

I know which side you are on. Honestly, when it comes to variability in many cases generics perform better than the originator products. Pharmaceutical technology improves and the originator doesn’t want to change “the winning team” knowing that a major variation would require a BE-study.

❝ In the very beginning of this scaling discussion someone stated (regarding replicate for Reference): "Why should I characterize the REFERENCE product? This should f**ing do the originator!" No joke...

Les Benet at the BioInternational ’94 in Munich. You’ve been there…

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


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Complete thread:

• Replicate designs VSL 2017-01-31 06:47 
  • Replicate designs: Pros & Cons Helmut 2017-01-31 12:42
    • Replicate designs: Pros & Cons VSL 2017-01-31 14:03
    • Replicate designs: Pros & Cons Balaji 2017-03-04 11:19
      • Partial replicate design & ABE for the FDA Helmut 2017-03-06 11:40
        • Partial replicate design & ABE for the FDA nobody 2017-03-06 13:47
          • Partial replicate design & ABE for the FDAHelmut 2017-03-06 14:00
            • Partial replicate design & ABE for the FDA nobody 2017-03-06 14:18
              • Partial replicate design & ABE for the FDA Helmut 2017-03-06 17:49