Bioequivalence and Bioavailability Forum

⚠️ Error 406 (in posting or replying) Helmut 2022-10-29 17:00 [Tips / Tricks]📌

Requesting data for a publication 📥 ♻️ 🚀 Helmut 2023-02-23 10:46 [General Statistics]📌

⚠️ Read before registering Helmut 2016-04-14 23:39 [Tips / Tricks]📌

Population BE [PBE] jdfr 2024-12-05 16:34 [Regulatives / Guidelines]

Mixed effects model: ML or REML Mahmoud 2024-12-05 11:20 [General Statistics]

Do regulatory agencies accept steady-state equivalence studies? libaiyi 2024-12-04 08:34 [Design Issues]
- HVD(P)s: steady state = history Helmut 2024-12-04 09:37
  - HVD(P)s: steady state = history libaiyi 2024-12-04 09:52
    - HVD(P)s: steady state = history dshah 2024-12-05 07:22

how to construct confidence interval for un-transformed metric? lizhao 2016-02-17 19:01 [Power / Sample Size]
- how to construct confidence interval for un-transformed metric? jag009 2016-02-17 20:43
- how to construct confidence interval for un-transformed metric? mittyri 2016-02-17 22:34
  - Fieller’s confidence interval Helmut 2016-02-18 13:38
    - Fieller’s confidence interval lizhao 2016-02-22 20:20
      - Fieller’s confidence interval yjlee168 2016-02-23 08:23
      - Rescue approaching – PowerTOST d_labes 2016-02-23 09:08
        
        Rescue approaching – PowerTOST Weidson 2024-11-28 23:15
        
        Why not base 🇷? Helmut 2024-12-03 13:39

3rd Bioequivalence Conference 26 Feb 2025 in Amsterdam SMA 2024-11-28 11:33 [Conferences / Workshops]

ISR Loky do 2024-11-21 12:04 [Study Assessment]
- ISR qualityassurance 2024-11-21 13:53
  - ISR Loky do 2024-11-22 12:16
    - ISR dshah 2024-11-27 12:46
    - ISR qualityassurance 2024-11-27 14:27

First Point Cmax USFDA NK 2024-09-13 06:48 [Study Assessment]
- First Point Cmax (also ICH M13A) Helmut 2024-09-17 08:38
  - First Point Cmax (also ICH M13A) kimhuang 2024-11-27 08:49
    - FDA M13A Helmut 2024-11-27 13:50
- First Point Cmax (also ICH M13A) dshah 2024-11-27 12:50

Group-by-Treatment Interaction (another round) Helmut 2024-11-27 12:01 [Study Assessment]

Possible reasons for group effect GM 2019-07-20 07:36 [Design Issues]
- Group “effect” Helmut 2019-07-20 14:02
- Possible reasons for group effect ElMaestro 2019-07-20 19:20
  - Possible reasons for group effect GM 2019-07-23 06:23
    - “Group-by-Treatment Interaction” Helmut 2019-07-23 10:32
      - “Group-by-Treatment Interaction” BEQool 2024-10-22 12:39
        
        “Group-by-Treatment Interaction” Helmut 2024-10-22 12:47
        
        OT: A choice between mittyri 2024-10-22 16:03
        
        OT: A choice between BEQool 2024-10-23 11:02
        
        OT: A choice between Helmut 2024-10-23 11:58
        
        OT: A choice between BEQool 2024-10-23 13:17
        
        OT: A choice between Helmut 2024-10-23 13:22
        Groups: Overlapping CIs Helmut 2024-11-03 11:36
        
        Groups: Overlapping CIs BEQool 2024-11-05 09:14
        
        Groups: Overlapping CIs Helmut 2024-11-05 10:12
        
        Groups: Overlapping CIs BEQool 2024-11-06 07:44
        
        Groups: (Hardly‽) overlapping CIs Helmut 2024-11-21 13:20
        
        Groups: (Hardly‽) overlapping CIs BEQool 2024-11-22 12:32
        
        Groups: (Hardly‽) overlapping CIs Helmut 2024-11-22 12:58
        Multiplicity? Helmut 2024-11-23 13:05
        
        Groups BEQool 2024-11-26 08:15

ANVISA Guidelines on Participant Involvement in Clinical Trials Rajul9 2024-11-24 18:19 [Regulatives / Guidelines]

ICHM13/High risk products Mikkabel 2024-11-20 09:00 [Regulatives / Guidelines]
- ICHM13/High risk products Helmut 2024-11-21 09:23
  - ICHM13/High risk products Mikkabel 2024-11-21 10:38
    - ICHM13/High risk products Ohlbe 2024-11-21 11:49
      - ICHM13/High risk products Mikkabel 2024-11-21 15:26
        
        ICHM13/High risk products Ohlbe 2024-11-22 10:51
        
        Generic vs. hybrid Helmut 2024-11-22 13:17

Baseline correction vs non-baseline correction jag009 2015-09-15 20:29 [Regulatives / Guidelines]
- Baseline correction vs non-baseline correction Lucas 2015-09-16 14:16
  - Baseline correction vs non-baseline correction Relaxation 2015-09-18 10:25
- Baseline correction or supra-therapeutic dose Helmut 2015-09-16 15:16
  - Baseline correction or supra-therapeutic dose Ohlbe 2015-09-16 17:55
    - Baseline profile prior to each period? Helmut 2015-09-16 18:15
    - Baseline correction examples Helmut 2015-09-17 15:44
      - Baseline correction examples Lucas 2015-09-18 14:19
        
        Baseline correction examples Helmut 2015-09-18 17:28
        
        Baseline correction examples Mauricio Sampaio 2016-02-07 03:05
        
        Baseline correction examples Lucas 2016-02-10 11:48
        
        Postmenopausal women Helmut 2016-02-10 12:26
        Baseline correction examples Mauricio Sampaio 2016-02-11 01:38
        Baseline correction examples Dr_Dan 2016-02-11 09:22
        
        Postmenopausal women Mauricio Sampaio 2016-02-12 03:24
        
        Postmenopausal women Dr_Dan 2016-02-15 17:45
        
        Baseline correction examples BEQool 2024-11-11 07:34
        
        Baseline correction GeoMean and Median mittyri 2024-11-11 11:20
        
        Geometric mean? Helmut 2024-11-11 14:53
        
        Geometric mean? BEQool 2024-11-14 08:19
        
        Geometric mean ≈ MLE of median Helmut 2024-11-14 09:54
        
        Geometric mean ≈ MLE of median Mahmoud 2024-11-15 11:26
        
        Bias? Helmut 2024-11-16 08:43
        
        Bias? Mahmoud 2024-11-16 11:12
    - Baseline; another example Helmut 2015-09-18 17:16
      - Baseline; another example nobody 2016-02-12 09:10
        
        Baseline; another example Helmut 2016-02-12 13:37
        
        Baseline; another example nobody 2016-02-12 14:08
        
        Slowly going OT: BE study simulations Helmut 2016-02-12 15:47
        
        Slowly going OT: BE study simulations nobody 2016-02-12 16:15
        
        Religious debate Helmut 2016-02-12 17:04
        
        Religious debate nobody 2016-02-12 17:26
        
        Religious debate ElMaestro 2016-02-13 12:53
        
        Religious debate nobody 2016-02-14 15:23
        
        Slowly going OT: BE study simulations Ohlbe 2016-02-13 13:10
        
        Slowly going OT: BE study simulations Helmut 2016-02-13 15:02
        
        Slowly going OT: BE study simulations lizhao 2016-02-25 17:31
        
        Business as usual Helmut 2016-02-25 17:44
        
        Business as usual lizhao 2016-02-25 17:59

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