Bioequivalence and Bioavailability Forum • FDA’s example data sets

FDA’s example data sets [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2013-02-21 18:18 (4465 d 14:00 ago) – Posting: # 10094
Views: 12,444

Hi John,

❝ Has FDA ever published (or presented) data of withinsubject CV from test and reference from submitted full replicate studies?

Yes. I’m too lazy to search as well. Maybe I dig out the link later on.* It was in the good (?) ol’ days when FDA was interested in subject-by-formulation interaction and requested replicate studies. The data sets are somewhere at FDA’s site in TXT-format. No CVs, so you have to run the analyses yourself. Only the classes of drugs are given.

http://www.fda.gov/Drugs/ScienceResearch/ucm301277.htm

B. The following data show that the test formulation has a higher intrasubject variability than the reference formulation (s_WT /s_WR ratio > 1.5)
AUC: Drugs # 15a, 15b, 15c, 15e
Cmax: Drugs # 15a, 15c, 15e, 15f, 16e, 16f

C. The following data show that the test formulation has a lower intrasubject variability than the reference formulation (s_WT /s_WR ratio < 0.667)
AUC: Drugs # 1, 5, 7
Cmax: Drugs # 1, 7, 14c, 14d

Too bad that data sets 14, 15, 16 are not online…

BTW, following [msg]this thread[/msg] about data exclusion:
Drug 1: AUC_t (n=156), AUC_∞ (n=155)
Drug 2: AUC_t (n=98), AUC_∞ (n=92)
Drug 3a: AUC_t (n=140), AUC_∞ (n=138)

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Complete thread:

SABE or Normal BE? luvblooms 2013-02-19 05:07
- FDA: rSABE for NTIDs Helmut 2013-02-19 11:05
- SABE or Normal BE? jag009 2013-02-19 15:23
  - Sample size? Helmut 2013-02-19 17:25
  - SABE or Normal BE? luvblooms 2013-02-20 05:26
    - SABE or Normal BE? jag009 2013-02-20 15:20
    - SABE or Normal BE? Helmut 2013-02-20 15:45
      - SABE or Normal BE? ElMaestro 2013-02-20 16:08
        
        SABE or Normal BE? jag009 2013-02-21 17:10
        
        FDA’s example data setsHelmut 2013-02-21 17:18
        
        FDA’s example data sets jag009 2013-02-21 20:14
        
        FDA’s example data sets Helmut 2013-02-21 22:42
        
        FDA’s example data sets jag009 2013-02-22 15:46
        
        FDA’s example data sets Helmut 2013-02-22 16:33