Bioequivalence and Bioavailability Forum • Reference scaled BE

Reference scaled BE - FDA (and FARTSSIE update) [RSABE / ABEL]

posted by KR – India, 2010-04-27 15:14 (5893 d 10:01 ago) – Posting: # 5246
Views: 41,807

Dear Dave,

It is really a valuable and appreciable work done. Thanks.

However, in "Bioequivalence, Replicate" sheet, I have one concern: FDA recommends 3 period, 3 sequence crossover study but there is only one option of 3 period, 2 sequence (ABB/BAA) in the excel sheet which is not matching with the sequences given in the FDA recommendation. So in this case,the sample size calculated from the xls sheet and the sample size required for FDA recommended reference scaled study will remain the same ? Same case is for 4 period replicate study also.

Kindly provide your valuable comment on the same.

Thanks once again.

KR

Edit: Full quote removed (like in almost all your replies). Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]

Complete thread:

Reference scaled BE - FDA (and FARTSSIE update) ddubins 2010-04-26 20:28 [RSABE / ABEL]
- Reference scaled ABE - FDA d_labes 2010-04-27 08:58
  - Reference scaled ABE - FDA ElMaestro 2010-04-27 13:39
    - Factor 2 is unbiased d_labes 2010-04-27 14:30
    - Biased bonus from MoM d_labes 2010-05-04 12:10
      - Biased bonus from MoM ElMaestro 2010-05-04 12:54
        
        Mixed MoM d_labes 2010-05-04 14:40
        
        Mixed MoM ElMaestro 2010-05-04 15:08
        
        R and G, CSH and UN d_labes 2010-05-05 10:42
        
        A sailor gets confused ElMaestro 2010-05-05 11:49
        
        Confused V/Z matratzen and tips d_labes 2010-05-05 14:49
        
        superb post! ElMaestro 2010-05-05 21:32
        
        Gambling with UN d_labes 2010-05-06 11:00
        
        Mixed MoM yjlee168 2010-05-05 09:12
- Reference scaled BE - FDA (and FARTSSIE update)KR 2010-04-27 13:14
- Reference scaled BE - EMA Helmut 2010-04-27 14:58
  - Reference scaled BE - EMA ddubins 2010-04-27 17:52
    - Partial replicate design and FDA ABE code d_labes 2010-04-28 09:47
    - Reference scaled BE - EMA Helmut 2010-04-28 14:46
    - Switching - null sWR d_labes 2010-05-04 14:04
- The unknown x d_labes 2010-05-06 13:26
  - The unknown x jdetlor 2010-09-28 17:22
    - Unknown x corrected? d_labes 2010-10-01 12:14
      - Unknown x corrected? Qilex 2016-09-21 12:25
        
        Official unknown x d_labes 2016-09-21 13:22