Bioequivalence and Bioavailability Forum

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

posted by nobody – 2017-03-06 15:18 (2600 d 23:11 ago) – Posting: # 17141
Views: 10,992

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

Nice location, btw. (you still have the list of participants? ***glotz***)

...but even some 10 years ago (and later) from time to time this sentiment came up from Schlipsträgers...

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

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 FDAnobody 2017-03-06 14:18
              • Partial replicate design & ABE for the FDA Helmut 2017-03-06 17:49