Bioequivalence and Bioavailability Forum

An issues I always wondered about - "multiplicity" for power Relaxation 2015-11-06 10:25
- An issues I always wondered about - "multiplicity" for power ElMaestro 2015-11-06 10:39
- "multiplicity" for power d_labes 2015-11-06 13:52

Sample Size for Drugs Interaction studies Lara 2015-11-03 23:19
- Sample Size for Drugs Interaction studies d_labes 2015-11-04 11:12
- Sample Size for Drugs Interaction studies Helmut 2015-11-04 11:17
  - Sample Size for Drugs Interaction studies Lara 2015-11-04 18:28

Sample size with CV more than 100% Jay 2015-11-02 10:47
- Why not? d_labes 2015-11-02 11:08
  - Why not? Jay 2015-11-02 11:29
    - Sample size for HVD's d_labes 2015-11-02 13:06
      - EMA: MR – ABEL for partial AUCs Helmut 2015-11-02 14:35
        
        EMA: MR – ABEL for partial AUCs d_labes 2015-11-02 14:48

BE studies for Inhalants jag009 2015-10-19 20:32
- BE studies for Inhalants ElMaestro 2015-10-19 20:43
- BE studies for Inhalants BE-proff 2015-10-23 10:32

Power Calculation for Replicate study designs balakotu 2015-09-24 11:55
- Power Calculation for Replicate study designs with SAS d_labes 2015-09-24 14:38
- Beware of the partial replicate Helmut 2015-09-25 14:41

CV calculation avrahan 2014-09-17 21:40
- CV calculation Helmut 2014-09-18 01:21
  - CV calculation BRN 2015-08-26 16:52
    - CV(total) from CV(intra) and CV(inter) d_labes 2015-08-27 08:48

Adjusting for expected dropout-rate Helmut 2015-06-17 12:33
- Percentage calculation d_labes 2015-06-18 09:02
- Adjusting for expected dropout-rate - Nitpicking zizou 2015-08-18 23:34
  - Good point! Helmut 2015-08-19 02:20
    - Good point! intuitivepharma 2015-08-19 07:47
      - Copy paste error d_labes 2015-08-19 10:12
        
        Copy paste error intuitivepharma 2015-08-19 11:18
        
        PowerTOST <1.2.7? Helmut 2015-08-19 11:44
        
        PowerTOST <1.2.7? intuitivepharma 2015-08-26 14:41

post hoc power VSL 2015-07-01 19:37
- post hoc power ElMaestro 2015-07-01 20:08
- I’m sick of “100.0% power” Helmut 2015-07-02 01:18

intra subject variability of Tetrabenazine Debbie 2015-07-01 13:37

The power of post hoc power The Outlaw Torn 2015-05-13 12:49
- The power of post hoc power ElMaestro 2015-05-13 17:53
  - Ad hoc power d_labes 2015-05-13 20:18
    - Ad hoc power The Outlaw Torn 2015-05-14 11:38
      - Ad hoc power The Outlaw Torn 2015-06-15 11:20
        
        Hypotheses in non-inferiority trials mittyri 2015-06-16 21:52
        
        Hypotheses in non-inferiority trials The Outlaw Torn 2015-06-17 11:35
        
        Hypotheses in non-inferiority trials d_labes 2015-06-18 10:17
        
        Hypotheses in non-inferiority trials The Outlaw Torn 2015-06-22 10:23
        
        Hypotheses in non-inferiority trials arjunroy 2015-06-29 08:24

CV inter-subject john john 2015-05-06 12:16
- Hydroxychloroquine Helmut 2015-05-06 13:18
  - Hydroxychloroquine john john 2015-05-06 13:28
    - pooled / total CV Helmut 2015-05-06 15:40
  - Hydroxychloroquine nobody 2015-05-06 17:50
    - Lousy review process Helmut 2015-05-06 18:21
      - Lousy review process nobody 2015-05-06 18:47
        
        Lousy review process Helmut 2015-05-06 18:50
        
        Lousy review process nobody 2015-05-06 18:57
      - Lousy review process nobody 2015-05-28 15:53
        
        Lousy review process Helmut 2015-05-28 16:00
        
        Lousy review process nobody 2015-05-28 16:10

Extrapolation john john 2015-05-13 13:36
- CVinter (or CVtotal) from CVintra Helmut 2015-05-13 14:33
  - CVinter (or CVtotal) from CVintra nobody 2015-05-13 14:53
    - OT: Drug Res Helmut 2015-05-13 15:11
      - OT: Drug Res nobody 2015-05-13 15:18
        
        completely OT Helmut 2015-05-13 15:29
        
        completely OT nobody 2015-05-13 15:37
  - CVinter (or CVtotal) from CVintra john john 2015-05-14 12:16
    - CVtotal ≠ CVintra + CVinter Helmut 2015-05-15 13:05
      - CVtotal ≠ CVintra + CVinter john john 2015-05-15 13:13
        
        CVtotal ≠ CVintra + CVinter Helmut 2015-05-15 13:14
        
        CVtotal ≠ CVintra + CVinter john john 2015-05-15 13:50
        
        CVtotal ≠ CVintra + CVinter Helmut 2015-05-15 14:07
        
        CVtotal ≠ CVintra + CVinter john john 2015-05-15 15:07
        
        CVtotal ≠ CVintra + CVinter Helmut 2015-05-15 15:10

minimum number of subject in bioequivalence study khaoula 2014-09-27 11:14
- minimum number of subject in bioequivalence study ElMaestro 2014-09-27 11:26
  - minimum number of subject in bioequivalence study khaoula 2014-09-27 23:49
    - “Overpowered” studies due to GLs Helmut 2014-09-28 01:13
      - “Overpowered” studies due to GLs khaoula 2014-09-28 22:36
        
        “Overpowered” studies due to GLs Helmut 2014-09-29 03:51
      - Scientific Validation for the Sample Size Formula mreyes 2014-11-07 19:47
        
        Basic maths Helmut 2014-11-07 20:09
        
        Basic maths mreyes 2014-11-07 20:47
        
        Reference for CI ⇒ MSE Helmut 2014-12-14 01:51
        
        Reference for CI ⇒ MSE mreyes 2015-02-19 19:50
        
        Failed study: power <80%! Helmut 2015-02-20 19:09
        
        Failed study: power <80%! mreyes 2015-02-23 17:07
        
        Reported 99.98%, correct 1.4% Helmut 2015-02-23 17:38
        
        Reported 99.98%, correct 1.4% ElMaestro 2015-02-23 17:51
        
        GMR ∉ AR ⇒ power <5% Helmut 2015-02-24 01:33
        
        GMR ∉ AR ⇒ power <5% mreyes 2015-02-24 17:34

Different strengths – different ISV? mittyri 2014-12-21 18:04
- Different strengths – different ISV? ElMaestro 2014-12-21 20:42
  - Different strengths – different ISV? Helmut 2014-12-22 03:07
    - Different strengths – thanks for advice mittyri 2014-12-22 20:33
    - Planning the study based on the previous results mittyri 2015-02-11 19:23
      - Planning the study based on the previous results ElMaestro 2015-02-11 20:29
      - Conservatism Helmut 2015-02-12 13:31

No of Vonteers requirment Srinetram 2015-01-08 06:41
- No of Vonteers requirment Dr_Dan 2015-01-08 09:31
- Sample size for scABE d_labes 2015-01-08 10:04
- FDA (RSABE) vs. EMA (ABEL) Helmut 2015-01-08 13:57

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