Bioequivalence and Bioavailability Forum

FDA: RSABE for NTID - Jay, 2018-03-26 13:31
- FDA: RSABE for NTID - jag009, 2018-03-26 17:57
  - FDA: RSABE for NTID - Jay, 2018-04-02 06:28
    - FDA: RSABE for NTID - pjs, 2018-04-02 15:07
      - FDA: RSABE for NTID - Jay, 2018-04-04 14:24
        
        β = 1 – π - Helmut, 2018-04-04 15:03
        
        Warfarin Sodium 95% Upper bound criteria - Nirali, 2019-01-30 15:38
        
        Upper bound in RSABE ≤0 - Helmut, 2019-02-02 14:15
        
        Upper bound in RSABE ≤0 - Nirali, 2019-02-12 07:10

Ratio % in ABE vs. Point Estimate in RSABE - Ahikal, 2019-01-27 17:49
- Specify the question - mittyri, 2019-01-28 14:23
  - Specify the question - Ahikal, 2019-01-29 08:58
    - 3b vs ABE PE FDA RSABE - mittyri, 2019-02-02 13:17
    - Data? - Helmut, 2019-02-02 13:31

ilat and dlat - Ahikal, 2019-01-27 17:52
- ilat and dlat in Progesterone guidance - mittyri, 2019-01-28 14:18
  - ilat and dlat in Progesterone guidance - Ahikal, 2019-01-29 09:00

RSABE - Sequence - Sundar.M, 2018-09-27 11:11
- Suggested: TRT|RTR - Helmut, 2018-09-28 13:15
  - Suggested: TRT|RTR - Sundar.M, 2018-09-28 13:36

Group Effect in Full Replicate Design - GM, 2018-09-12 07:17
- Group Effect in Full Replicate Design - Helmut, 2018-09-12 11:20
  - Group Effect in Full Replicate Design - GM, 2018-09-12 12:32
    - Group Effect in Full Replicate Design - Helmut, 2018-09-12 13:08
      - Group Effect in Full Replicate Design - GM, 2018-09-12 13:23
        
        Group Effect in Full Replicate Design - Helmut, 2018-09-12 15:09
        
        Group Effect in Full Replicate Design - GM, 2018-09-12 15:19
        
        Group Effect in Full Replicate Design - Helmut, 2018-09-12 15:31
        
        Group Effect in Replicate Design - zizou, 2018-09-12 23:30
        
        Group Effect in Replicate Design - Helmut, 2018-09-13 11:34

Parallel design - Reference scale - Sundar.M, 2018-09-07 14:17
- Parallel design & Reference-scaling - Helmut, 2018-09-07 15:27
  - Parallel design & Reference-scaling - Sundar.M, 2018-09-08 17:05

Calculate the BE limits for HVDPs based on EMA - libaiyi, 2018-06-08 11:41
- Calculate the BE limits for HVDPs based on EMA - Shuanghe, 2018-06-08 12:51
- (Expanded) BE limits, EMA-style - Helmut, 2018-06-08 13:19
  - (Expanded) BE limits, EMA-style - libaiyi, 2018-06-11 07:21
    - CFDA: Yet another story? - Helmut, 2018-06-11 12:24
      - CFDA: Yet another story? - libaiyi, 2018-06-12 11:09
        
        CFDA: Draft guidance? - Helmut, 2018-06-12 14:54
        
        CFDA: Draft guidance? - libaiyi, 2018-06-13 03:39
        
        Hypotheses generated “in face of the data” - Helmut, 2018-06-13 11:39
        
        Hypotheses generated “in face of the data” - libaiyi, 2018-06-14 03:46

[Opinion] Should the 90% CI for GMR be required to encompass 1 - bebac_fan, 2018-03-28 18:43
- [Opinion] Should the 90% CI for GMR be required to encompass 1 - ElMaestro, 2018-03-28 19:07
  - [Opinion] Should the 90% CI for GMR be required to encompass 1 - bebac_fan, 2018-03-28 19:23
    - [Opinion] Should the 90% CI for GMR be required to encompass 1 - ElMaestro, 2018-03-28 19:44
      - [Opinion] Should the 90% CI for GMR be required to encompass 1 - bebac_fan, 2018-03-28 20:05
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1 - jag009, 2018-03-28 21:25
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1 - bebac_fan, 2018-03-28 21:59
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1 - ElMaestro, 2018-03-28 23:03
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1 - bebac_fan, 2018-03-28 23:57
        
        Black Swan again - mittyri, 2018-04-05 17:57
- [Opinion] Should the 90% CI for GMR be required to encompass 1 - Helmut, 2018-03-28 23:57
  - [Opinion] Should the 90% CI for GMR be required to encompass 1 - bebac_fan, 2018-03-29 13:46
  - [Opinion] Should the 90% CI for GMR be required to encompass 1 - jag009, 2018-03-29 16:52
    - [Opinion] Should the 90% CI for GMR be required to encompass 1 - bebac_fan, 2018-03-29 16:57
      - [Opinion] Should the 90% CI for GMR be required to encompass 1 - jag009, 2018-03-29 19:55
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1 - bebac_fan, 2018-03-29 20:30
        
        [Opinion] Should the 90% CI for GMR be required to encompass 1 - jag009, 2018-03-29 21:22
        
        Paper & Presentations - Helmut, 2018-03-30 01:33
        
        Donald Schuirmann’s opinion - Helmut, 2018-04-10 14:41

Full replicate designed study for Europe - balakotu, 2018-03-31 11:59
- Full replicate designed study for Europe - bebac_fan, 2018-04-01 04:45
  - Full replicate designed study for Europe - ElMaestro, 2018-04-02 02:19

95% Upper bound calculation - GM, 2018-03-07 06:25
- 95% Upper bound calculation - Katrin_Ti, 2018-03-09 14:05
  - 95% Upper bound calculation - GM, 2018-03-13 05:09
    - 95% Upper bound calculation - Katrin_Ti, 2018-03-13 09:31

question of adjustment - Yura, 2017-04-25 15:14
- TIE depends on CVwR (and n) - Helmut, 2017-04-26 14:17
  - TIE depends on CVwR (and n) - Yura, 2017-04-26 17:28
    - TIE depends on CVwR (and n) - Helmut, 2017-04-26 18:00
      - TIE depends on CVwR (and n) - Yura, 2017-04-26 18:55
        
        TIE depends on CVwR (and n) - Yura, 2017-04-28 11:13
        
        TIE = p(BE) at expanded limits - Helmut, 2017-04-28 19:16
        
        TIE = p(BE) at expanded limits - Yura, 2017-04-29 13:01
  - TIE depends on CVwR (and n) - pjs, 2018-02-28 14:33
    - TIE depends on CVwR (and n) - Helmut, 2018-02-28 14:48
      - TIE depends on CVwR (and n) - pjs, 2018-03-01 07:35
        
        Comparing methods for (S)ABE - Helmut, 2018-03-01 13:32
        
        Comparing methods for (S)ABE - pjs, 2018-03-05 14:50
        
        Simulating the Null - Helmut, 2018-03-05 17:40
    - Adjusting α - Helmut, 2018-03-07 16:21

Validation of FDA's RSABE on NTIDs - yicaoting, 2017-08-22 18:01
- Validation of FDA's RSABE on NTIDs - Helmut, 2017-08-22 20:25
  - Validation of FDA's RSABE on NTIDs - yicaoting, 2017-08-23 05:30
    - Validation of FDA's RSABE on NTIDs - Helmut, 2017-08-23 15:00
      - Validation of FDA's RSABE on NTIDs - yicaoting, 2017-08-30 14:33
        
        Validation of FDA's RSABE on NTIDs - Helmut, 2017-08-30 15:04
  - Clarification needed: Validation of FDA's RSABE on NTIDs - CECIF, 2018-02-19 22:20
    - FDA's RSABE on NTIDs in R - d_labes, 2018-02-20 14:10
      - FDA's RSABE on NTIDs in R - CECIF, 2018-03-01 21:08
        
        FDA's RSABE on NTIDs in R - Helmut, 2018-03-01 23:39

Which is better for missing periods PROC GLM or PROC MIXED - Mohamed Yehia, 2018-01-23 09:48
- EMA: Method A or B - Helmut, 2018-01-23 11:25
  - EMA: Method A or B - Mohamed Yehia, 2018-01-23 11:56

How to calculate N1,N2,N3 and DF in missing Partial replicate - Junior, 2018-01-22 20:33

Partial replicate or Reference scaling - heaven sent, 2017-12-29 17:24
- Partial replicate ≠ Reference scaling - Helmut, 2017-12-29 18:36

alpha correction - Yura, 2017-12-08 08:48
- theta0 within PE-constraints [theta1, theta2] - Helmut, 2017-12-08 12:33
  - theta0 within PE-constraints [theta1, theta2] - Yura, 2017-12-08 12:55

Bioequivalence and Bioavailability Forum 12:49 CET