Bioequivalence and Bioavailability Forum • Two stage BE design

Two stage BE design [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2013-08-06 17:31 (4339 d 04:02 ago) – Posting: # 11226
Views: 26,752

Hi Mahesh,

❝ Is two stage …

Yes.

❝ … or Add-on BE design accepted by USFDA/CDER?

No (and never was – contrary to Canada and Japan).

As ElMaestro already pointed out FDA prefers variants of ‘Method C’.

FDA’s Bioequivalence Recommendations for Specific Products
- Draft Guidance on Loteprednol Etabonate; Tobramycin (06/2012)
- Draft Guidance on Lotepredenol Etabonate (04/2013)
- Interesting that the Draft Guidance on Dexamethasone/Tobramycin (06/2012) mentioned a sequential design as well, but the current revision (06/2013) states “The number of subjects to be enrolled should be determined from the results of a pilot study.” Why?
- There might be other guidances published in the meantime; please check yourself.
Davit BM. Sequential Designs and Interim Analyses in Bioequivalence: FDA’s Experience. Mini-Symposium on Adaptive Study Designs and Assessment Approaches for Bioequivalence. AAPS Annual Meeting, Chicago, IL, October 13–18, 2012.
Potvin D et al. Sequential design approaches for bioequivalence studies with crossover designs Pharm Stat. 2008;7(4):245–62. doi 10.1002/pst.294
Montague TH et al. Additional results for ‘Sequential design approaches for bio-equivalence studies with crossover designs’. Pharma Stat. 2011;11(1):8–13. doi 10.1002/pst.483
Fuglsang A.Sequential Bioequivalence Trial Designs with Increased Power and Controlled Type I Error Rates. AAPS J. 2013;15(3):659–61. doi 10.1208/s12248-013-9475-5

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Complete thread:

Acceptance by FDA/CDER Mahesh 2013-08-06 06:12
- Two stage BE design ElMaestro 2013-08-06 10:05
- Two stage BE designHelmut 2013-08-06 15:31
  - Two stage BE design Mahesh 2013-08-07 06:51
    - Two stage BE design kumarnaidu 2013-10-17 15:08
      - Two stage BE design ElMaestro 2013-10-17 17:28
        
        Two stage BE design kumarnaidu 2013-10-18 05:59
        
        EMA vs. rest of the world Helmut 2013-10-18 14:42
        
        Two stage BE design — cold water thrown on our head Shuanghe 2013-10-18 10:05
        
        Open your mouth and forcefully spit the water out Helmut 2013-10-18 13:29
        
        Change in statistical design kumarnaidu 2013-10-19 07:52
        
        Bad idea Helmut 2013-10-19 15:04
        
        Bad idea kumarnaidu 2013-10-21 06:01
        
        Change to Method B? Helmut 2013-10-21 14:51
        
        Change to Method B? kumarnaidu 2013-10-22 06:15
        
        Simulations Helmut 2013-10-22 13:20
        
        Open your mouth and forcefully spit the water out Shuanghe 2013-10-22 09:03
        
        Reach for the stars Helmut 2013-10-22 13:05
        
        Alpha inflation in two stage design kumarnaidu 2013-12-04 13:43
        
        Deficiency letters Helmut 2013-12-04 14:50
        
        Deficiency letters kumarnaidu 2013-12-05 06:18
        
        Simulations Helmut 2013-12-05 15:51
        
        Simulations kumarnaidu 2013-12-05 16:07
        
        Simulations Helmut 2013-12-05 16:55
        
        Simulations kumarnaidu 2013-12-06 06:07
        
        Ejaculatio praecox Helmut 2013-12-06 14:30
        
        Ejaculatio praecox kumarnaidu 2013-12-06 15:13
        
        All effects fixed Helmut 2013-12-06 15:31
        
        All effects fixed kumarnaidu 2013-12-09 07:33
        
        EMA… Helmut 2013-12-09 12:45