Bioequivalence and Bioavailability Forum

Subject: Issue with PBE Calculation When Stage = 1 weiguo2122 2025-01-13 20:19
- Subject: Issue with PBE Calculation When Stage = 1 ElMaestro 2025-01-13 21:08

ANVISA Guidelines on Participant Involvement in Clinical Trials Rajul9 2024-11-24 18:19
- ANVISA Guidelines on Participant Involvement in Clinical Trials drgunasakaran1 2025-01-13 13:13

Population BE [PBE] jdfr 2024-12-05 16:34
- Population BE [PBE] ElMaestro 2024-12-17 22:50
  - Population BE [PBE] jdfr 2025-01-06 11:14
    - Population BE [PBE] ElMaestro 2025-01-06 12:52
      - Population BE [PBE] jdfr 2025-01-07 12:08
        
        Population BE [PBE] ElMaestro 2025-01-07 13:50
        
        Population BE [PBE] jdfr 2025-01-07 17:10
        
        Population BE [PBE] ElMaestro 2025-01-07 18:55
        
        Population BE [PBE] jdfr 2025-01-08 10:13
        
        Population BE [PBE] ElMaestro 2025-01-08 11:02
        
        Population BE [PBE] jdfr 2025-01-08 17:45
        Population BE [PBE] jdfr 2025-01-09 09:16
        
        Population BE [PBE] ElMaestro 2025-01-09 14:46

Clinical strategy for generic of biosimilar qualityassurance 2025-01-09 08:41

ICHM13/High risk products Mikkabel 2024-11-20 09:00
- 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
- 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

Shipment of Investigational Medicinal products qualityassurance 2024-10-30 13:47
- Shipment of Investigational Medicinal products Ohlbe 2024-11-05 22:11
  - Shipment of Investigational Medicinal products qualityassurance 2024-11-06 14:15

FDA: Update of PSGs to align with ICH M13A Helmut 2024-10-03 15:58
- FDA: ICH M13A, Q&A, PSGs, and a rant Helmut 2024-11-01 08:58

"Dose or Strength to be Studied" in ICH M13A Darborn 2024-09-30 01:14
- "Dose or Strength to be Studied" in ICH M13A BEQool 2024-10-07 10:33
  - "Dose or Strength to be Studied" in ICH M13A Darborn 2024-10-08 00:58

Draft guideline on quality and equivalence of topical products – still stuck? mittyri 2024-09-14 20:24
- Patience… Helmut 2024-09-18 08:22
  - MWP Ohlbe 2024-09-18 10:26
    - Final & published Helmut 2024-10-03 11:44

ICH M13 Guidance and Health Canada AB661 2024-10-01 05:09
- ICH M13A/C and Health Canada Helmut 2024-10-01 06:29

Pooling of studies? Helmut 2024-09-02 13:55
- coverage probability mittyri 2024-09-02 17:22
- M13 Ohlbe 2024-09-02 17:37
  - M13 Q&A Helmut 2024-09-06 08:31

Cholestyramine and colesevelam in Vitro binding studies jansari 2024-09-02 17:25

Acute and Sub-acute toxicity studies for FDA ANDAs Achievwin 2024-08-05 18:50
- Acute and Sub-acute toxicity studies for FDA ANDAs NK 2024-08-06 04:06
  - Acute and Sub-acute toxicity studies for FDA ANDAs Achievwin 2024-08-27 02:42

EU Reference Medicinal Product – Flexible or Absolute? PE 2024-08-20 10:39
- EEA Reference Medicinal Product: Mandatory Helmut 2024-08-20 12:17