Bioequivalence and Bioavailability Forum

Missing periods in replicate designs Helmut 2019-10-16 13:14 [RSABE / ABEL]
- Missing periods in replicate designs ElMaestro 2019-10-16 15:10
  - Missing samples Helmut 2019-10-17 10:22
- Missing periods in replicate designs d_labes 2019-10-17 17:22
  - Missing periods in replicate designs ElMaestro 2019-10-17 20:17
    - Missing periods in replicate designs d_labes 2019-10-18 11:48
  - Missing periods in replicate designs Helmut 2019-10-19 14:30
    - Missing periods in replicate designs: save the data? Astea 2019-10-20 14:46
      - Missing periods in replicate designs: save the data? Helmut 2019-10-20 15:23
        
        Missing periods in replicate designs: kill the data? Astea 2019-10-21 01:59
        
        Meaningful data? Helmut 2019-10-21 11:37
- Missing periods in replicate designs Mahmoud 2019-11-06 11:41
  - Kenward-Roger? Helmut 2019-11-06 12:49
    - Kenward-Roger? PharmCat 2019-11-06 14:43
      - Kenward-Roger ≥ Satterthwaite Helmut 2019-11-08 20:57
        
        Kenward-Roger ≥ Satterthwaite PharmCat 2019-11-08 22:08
      - Kenward-Roger - links mittyri 2019-11-08 22:59
        
        Kenward-Roger - links PharmCat 2019-11-09 00:51
        degrees of freedom Helmut 2019-11-09 16:22
        
        degrees of freedom PharmCat 2019-11-09 19:11

Denmark Curiosa (1 in 90% CI in 0.8-1.25) zizou 2017-02-05 02:03 [Power / Sample Size]
- Kudos! Helmut 2017-02-05 19:16
  - Kudos! ElMaestro 2017-02-05 21:15
    - Joking! Helmut 2017-02-06 13:27
      - Thanks, and DKMA ElMaestro 2017-02-06 13:46
        
        Power with a Danish twist Helmut 2017-02-07 15:23
        
        Danish ultra-conservatism d_labes 2017-02-08 10:57
        
        Danish ultra-conservatism Helmut 2017-02-08 11:47
    - Kudos to ElMaestro! d_labes 2017-02-06 15:06
      - Plausible Helmut 2017-02-06 17:16
        
        Plausible to me too d_labes 2017-02-06 20:25
        
        Plausible to me too ElMaestro 2017-02-06 22:30
        Plausible to me too zizou 2017-02-06 22:42
        
        THX d_labes 2017-02-07 10:01
- 3D Helmut 2017-02-06 13:47
- Denmark Curiosa (1 in 90% CI in 0.8-1.25) d_labes 2017-02-06 14:54
  - Denmark Curiosa (1 in 90% CI in 0.8-1.25) zizou 2017-02-08 21:03
    - Alternative CI for BE decision d_labes 2017-02-09 11:18
      - Alternative CI for BE decision ElMaestro 2017-02-09 11:36
        
        Alternative CI for BE decision d_labes 2017-02-09 11:48
        
        How decidedly odd ElMaestro 2017-02-09 13:28
        
        How decidedly odd zizou 2017-02-09 14:42
        
        Alternative CI for BE decision Helmut 2017-02-09 13:41
        
        No alternative d_labes 2017-02-09 20:37
        
        No alternative ElMaestro 2017-02-10 13:51
        
        No alternative? mittyri 2017-02-10 15:28
        
        Dinamarka? d_labes 2017-02-10 20:10
        
        OT: Czech beer d_labes 2017-02-10 19:57
- Denmark Curiosa (1 in 90% CI in 0.8-1.25): Gone Helmut 2019-11-08 12:47

PuMas - introducing Julia in pharmacometrics yjlee168 2019-11-06 23:44 [Software]
- PuMas - introducing Julia in pharmacometrics PharmCat 2019-11-07 10:28

Least square mean calculation for the fully replicate design Jaimik Patel 2019-10-31 11:19 [General Statistics]
- Very, very strange! Helmut 2019-10-31 14:36
  - Very, very strange! Shuanghe 2019-10-31 19:43
    - Very, very strange! Helmut 2019-10-31 19:50
  - Very, very strange! Jaimik Patel 2019-11-02 12:26
    - G matrix mittyri 2019-11-03 01:38
- Inner workings of REML ElMaestro 2019-10-31 19:48
  - Even in ANOVA… Helmut 2019-10-31 19:53
    - Even in 2x2... zizou 2019-11-01 21:05
      - trying to understand emmeans mittyri 2019-11-02 02:26
- Least square mean calculation for the fully replicate design PharmCat 2019-11-03 00:46

Big Pharma strikes back with data secrecy mittyri 2019-10-28 10:13 [Off Topic]
- Big Pharma strikes back with data secrecy Relaxation 2019-10-28 14:56
  - OOT: Sci-Hub Helmut 2019-10-28 15:42
    - OOT: Sci-Hub nobody 2019-10-28 20:33
      - OOT: ICBM Helmut 2019-10-30 14:50
        
        OOT: ICBM nobody 2019-10-30 21:42

standby and retention samples zeynep 2019-10-24 12:22 [Regulatives / Guidelines]
- standby and retention samples Ohlbe 2019-10-24 13:34
  - standby and retention samples zeynep 2019-10-24 14:21
    - Reserve samples? Helmut 2019-10-24 14:32
      - Spare subjects? ElMaestro 2019-10-24 14:38
        
        Spare subjects? Ohlbe 2019-10-24 17:59
        Spare subjects? jag009 2019-10-24 19:39
    - standby and retention samples Ajit Thorat 2019-10-30 11:31

Dissolution Testing Requirement - ANDA jag009 2019-10-30 02:29 [Dissolution / BCS / IVIVC]

If method doesn't exist in FDA Disso Database jag009 2019-10-24 20:54 [Dissolution / BCS / IVIVC]
- USP should be fine Helmut 2019-10-25 00:33
  - USP should be fine jag009 2019-10-30 02:23

SUPAC level 3 changes for MR formulations Mithu 2019-09-30 07:42 [Regulatives / Guidelines]
- SUPAC level 3 changes for MR formulations jag009 2019-10-22 21:31
  - SUPAC level 3 changes for MR formulations Mithu 2019-10-23 09:21
    - SUPAC level 3 changes for MR formulations jag009 2019-10-24 05:34

12 units from 12 different bottles should be used - Dissolution for Suspensions bharathi 2019-09-26 12:20 [Regulatives / Guidelines]
- 12 units from 12 different bottles should be used - Dissolution for Suspensions jag009 2019-10-22 21:29

Emesis criteria for study comparing IR vs. MR formulations Rock 2019-10-16 13:38 [Study Performance]
- Emesis criteria for study comparing IR vs. MR formulations Helmut 2019-10-16 13:53
  - Emesis criteria for study comparing IR vs. MR formulations nobody 2019-10-16 15:22
    - Almost OT Helmut 2019-10-16 17:24
      - Almost OT nobody 2019-10-16 18:41
        
        Completely OT Helmut 2019-10-16 19:02
  - median Tmax mittyri 2019-10-17 00:01
    - median Tmax Helmut 2019-10-17 08:42
    - median Tmax jag009 2019-10-22 21:26

EU, method C preference ElMaestro 2019-10-11 10:25 [Two-Stage / GS Designs]
- On the contrary, my dear Dr Watson! Helmut 2019-10-11 11:52
  - On the contrary, my dear Dr Watson! nobody 2019-10-11 17:39
    - On the contrary, my dear Dr Watson! Helmut 2019-10-11 17:47
      - On the contrary, my dear Dr Watson! ElMaestro 2019-10-11 18:01
        
        On the contrary, my dear Dr Watson! nobody 2019-10-11 18:08
        On the contrary, my dear Dr Watson! Helmut 2019-10-11 18:11
- EU: simulation-based methods in agony Helmut 2019-10-19 12:38
  - EU: ABEL TIE?? mittyri 2019-10-19 23:24
    - Reference-scaling: only simulations possible Helmut 2019-10-20 13:58

Bicalutamide having Long Half Life udayk 2019-10-04 12:06 [Design Issues]
- Bicalutamide: Crossover not realistic Helmut 2019-10-07 14:59
  - Bicalutamide: Crossover not realistic udayk 2019-10-10 09:10

how to get t50%GIR-AUC(0-8h) in winnolin? Aisha.ma 2019-10-07 07:46 [Software]
- POT-50 Helmut 2019-10-07 09:52
  - POT-50 Aisha.ma 2019-10-07 16:12
    - AUC-apical? Helmut 2019-10-07 16:58
      - AUC-apical? Aisha.ma 2019-10-07 18:43
        
        Define your terms! Helmut 2019-10-07 18:54
        
        Define your terms! Aisha.ma 2019-10-07 19:02
        
        Define your terms! nobody 2019-10-08 10:51

EMA: Mahalanobis distance is dead... Helmut 2018-11-09 18:01 [Dissolution / BCS / IVIVC]
- EMA: Mahalanobis distance is dead... ElMaestro 2018-11-09 19:12
  - Is ƒ2 dead as well – always bootstrapping? Helmut 2019-10-06 15:27
    - Is ƒ2 dead as well – always bootstrapping? ElMaestro 2019-10-06 17:54
      - Ahem – number of units? Helmut 2019-10-06 18:14
        
        Ahem – number of units? ElMaestro 2019-10-06 22:45
        
        Ahem – number of units? wienui 2019-10-07 19:11