Bioequivalence and Bioavailability Forum • Partial replicate design & ABE for the FDA

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

posted by Helmut – Vienna, Austria, 2017-03-06 18:49 (2605 d 08:25 ago) – Posting: # 17142
Views: 11,067

❝ Nice location, btw. ;-)

Yep.

❝ (you still have the list of participants? ***glotz***)

Can’t remember whether one existed. I only have the list of organizers and speakers.

❝ Re. Test better than Ref: But you can't know in advance …

Only an educated guess from a pilot.

❝ … and if you have a look at some of the "companies" nowadays "developing" generics your "gut feeling"/experience from the past might be subjected to some change (as so many things nowadays...)

All too true.

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

Replicate designs VSL 2017-01-31 06:47 [Design Issues]
- 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 FDA Helmut 2017-03-06 14:00
        
        Partial replicate design & ABE for the FDA nobody 2017-03-06 14:18
        
        Partial replicate design & ABE for the FDAHelmut 2017-03-06 17:49