Bioequivalence and Bioavailability Forum

Replicate/Partial Replicate design acceptance criteria rohitkachhadiya 2013-04-19 11:46
- linearized form (Howe’s approximation) Helmut 2013-04-19 14:12

4way full replicate SAS routine from FDA guidance jag009 2013-04-08 20:18
- Merging problems? Helmut 2013-04-09 02:58
  - Merging problems? jag009 2013-04-09 20:12
    - critbound? Helmut 2013-04-10 17:32
      - critbound? jag009 2013-04-10 21:22

EMA dataset 1 trouble ElMaestro 2013-04-08 20:23
- complete (RR) only Helmut 2013-04-09 02:37
- EMA dataset 1 - programmers trouble d_labes 2013-04-09 09:01
  - Still not exactly sure ElMaestro 2013-04-09 10:12
    - Still not exactly sure - why d_labes 2013-04-09 15:57
      - My problem(s) ElMaestro 2013-04-09 16:39
      - More confusion ElMaestro 2013-04-09 23:29
        
        Confusion help d_labes 2013-04-10 10:51

SAS Procedure on Partial Replicate (TRR) Study Data jag009 2013-04-02 21:11
- Confusing… Helmut 2013-04-03 13:42
  - Confusing… jag009 2013-04-03 16:06
    - Confusing… Helmut 2013-04-03 21:49
      - Confusing… jag009 2013-04-03 23:01
        
        Confusing… Helmut 2013-04-03 23:22
        
        Confusing… jag009 2013-04-04 15:59
        Confusing… jag009 2013-04-04 17:21
        
        2nd opinion Helmut 2013-04-05 01:01
        
        2nd opinion jag009 2013-04-05 15:24
        
        3rd, 4th opinion d_labes 2013-04-05 11:04
        
        3rd, 4th opinion jag009 2013-04-05 15:41
        
        Beer swaped d_labes 2013-04-05 16:09
        
        Beer swaped jag009 2013-04-05 17:18

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 sets Helmut 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

Partial replicate study questions jag009 2013-02-18 15:47
- RR data only? Helmut 2013-02-19 12:51
  - RR data only? jag009 2013-02-19 20:31
    - RR data only? Helmut 2013-02-19 20:37

BE with 1 not included in CI ? Coja66 2013-01-16 10:12
- BE with 1 not included in CI ? ElMaestro 2013-01-16 11:38
  - BE with 1 not included in CI -danish twist d_labes 2013-01-16 15:07
    - BE with 1 not included in CI -danish twist ElMaestro 2013-01-16 17:46
      - BE with 1 not included in CI -danish twist The Outlaw Torn 2013-01-17 13:27
    - BE with 1 not included in CI -danish twist bjkim97 2013-02-06 05:56
      - EMA widenend ABEL d_labes 2013-02-06 09:27

FDA’s aggregate BE for NTIDs: example Helmut 2013-01-13 15:54
- 404 d_labes 2013-01-13 19:06
  - URL corrected Helmut 2013-01-13 20:49
    - URL corrected jag009 2013-01-14 21:09
      - THX! Helmut 2013-01-14 21:50
        
        THX! jag009 2013-01-14 21:53
        
        Home stretch Helmut 2013-01-14 22:07
        
        Home stretch jag009 2013-01-14 22:24
        
        estimate K2K 2013-01-16 04:48
        
        only a typo in John’s code Helmut 2013-01-16 14:00
        
        only a typo in John’s code K2K 2013-01-17 04:46
- FDA’s aggregate BE for NTIDs: example jag009 2013-01-14 23:04
  - Variances from ABE: different model Helmut 2013-01-15 15:41
    - Variances from ABE: different model jag009 2013-01-15 17:58
      - Variances from ABE: different model Helmut 2013-01-15 18:09
        
        Variances from ABE: different model jag009 2013-01-15 18:17
        
        Yep. Almost there. Helmut 2013-01-15 23:30
        
        Yep. Almost there. jag009 2013-01-16 16:14
        
        Done Helmut 2013-01-20 12:58
        
        Variances from ABE: different model jag009 2013-01-15 18:19
        
        Variances from ABE: different model Helmut 2013-01-15 18:29
        
        Variances from ABE: different model jag009 2013-01-15 19:49
        Variances from ABE: different model jag009 2013-01-16 19:35
        
        Variances from ABE: different model Helmut 2013-01-16 19:39

Phoenix/WinNonlin 6.2.1: 95% upper bound limit K2K 2013-01-15 13:18
- Phoenix/WinNonlin 6.2.1: 95% upper bound limit jag009 2013-01-15 15:16
- Phoenix/WinNonlin: get 6.3! Helmut 2013-01-15 15:51
  - Phoenix/WinNonlin: get 6.3! K2K 2013-01-16 04:35

FDA’s RSABE code (lenghty!) Helmut 2012-01-03 03:27
- FDA’s RSABE code (lenghty!) jag009 2013-01-14 19:47
  - FDA’s RSABE code (lenghty!) Helmut 2013-01-14 21:40

Partial replicate for USA balakotu 2013-01-10 08:37
- Overspecified model d_labes 2013-01-10 10:24

Replicate Design: Scaling FDA Ben 2012-10-23 11:32
- Maybe – but why? Helmut 2012-10-23 15:35
  - Maybe – but why? Ben 2012-10-23 16:03
    - Got it. Helmut 2012-10-23 16:23
  - FDA Mixed up d_labes 2012-10-23 16:23
    - FDA Mixed up Helmut 2012-10-23 16:34
  - Maybe – but why? Ben 2012-10-27 17:04
    - Maybe – but why? Helmut 2012-10-27 17:57
      - Maybe – but why? Ben 2012-10-28 13:57
        
        Potvin (and beyond?) Helmut 2012-10-28 15:59
        
        Potvin (and beyond?) Ben 2012-11-01 10:17

SABE - FDA jag009 2012-10-26 22:54
- Progesterone draft (April 2010) Helmut 2012-10-26 23:04

Ref. vs. Ref. in partial replicate design d_labes 2012-04-25 15:52
- Ref. vs. Ref. in partial replicate design again d_labes 2012-10-10 10:56
- Ref. vs. Ref. in partial replicate design ElMaestro 2012-10-10 12:39
  - Ref. vs. Ref. in partial replicate design d_labes 2012-10-10 16:26
    - Ref. vs. Ref. in partial replicate design ElMaestro 2012-10-10 17:16
      - R vs. R in partial replicate design d_labes 2012-10-11 09:43
        
        R1 vs R2 ElMaestro 2012-10-11 10:26
        
        R1 vs R2 d_labes 2012-10-11 12:01
        
        R1 vs R2 ElMaestro 2012-10-11 12:09
        
        R1 vs R2 d_labes 2012-10-11 12:46
        
        treatment df ElMaestro 2012-10-11 13:38
        
        Missunderstanding d_labes 2012-10-11 16:34
        
        Missunderstanding, crippled ElMaestro 2012-10-11 18:12
        
        EMA crippled method - R peculiarities d_labes 2012-10-12 14:54
        
        All is good, just forget ANOVA - you don't need it! ElMaestro 2012-10-12 16:25
        
        Just forget ANOVA. What next? d_labes 2012-10-15 08:35
        
        Just forget ANOVA. What next? ElMaestro 2012-10-15 10:04

SAS error in 3 way ref replicate study AB 2012-05-04 15:13
- SAS error in 3 way ref replicate study jag009 2012-05-04 15:36
  - SAS error in 3 way ref replicate study AB 2012-05-05 06:45
- FDA's ABE code and partial replicate design d_labes 2012-05-06 10:10
  - Arbitrary (and unjustified) cut-off of r² Helmut 2012-05-06 13:29
    - Anscombe quartet d_labes 2012-05-07 08:48
      - Anscombe quartet in R Helmut 2012-05-07 11:15
        
        Anscombe quartet in R AB 2012-05-07 12:07
    - Arbitrary (and unjustified) cut-off of r² FI 2012-10-08 10:39
      - Predominant half life; exclusions Helmut 2012-10-08 13:45
        
        Excluding time points for lambdaZ d_labes 2012-10-09 09:33
        
        Analytical variability Helmut 2012-10-09 14:09
        
        Answer machine d_labes 2012-10-09 15:15
        
        Well done! Helmut 2012-10-09 19:43

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