Bioequivalence and Bioavailability Forum

PBE Calculations when Number of Containers per Batch is Not Uniform studious_117 2026-01-26 20:35 [General Statistics]
- PBE Calculations when Number of Containers per Batch is Not Uniform ElMaestro 2026-01-27 20:14
  - PBE Calculations when Number of Containers per Batch is Not Uniform studious_117 2026-01-27 20:34
    - PBE Calculations when Number of Containers per Batch is Not Uniform ElMaestro 2026-01-27 21:47

Dosing of oral sprinkle granules Loky do 2025-12-04 18:54 [Design Issues]
- Dosing of oral sprinkle granules jag009 2026-01-21 18:24
- Dosing of oral sprinkle granules Darborn 2026-01-22 08:52

AUCinfinity BE requirement for Mexico and Brazil jag009 2026-01-20 16:52 [Regulatives / Guidelines]
- IR or MR? Helmut 2026-01-21 10:55
  - IR or MR? jag009 2026-01-21 18:19

Repeat BE only for failed analyte qualityassurance 2026-01-16 12:52 [Study Assessment]

Partial replicate design Silva 2013-12-31 12:17 [RSABE / ABEL]
- extra-reference design Helmut 2013-12-31 14:28
  - extra-reference design BEQool 2025-12-22 18:27
    - extra-reference design: R code mittyri 2025-12-23 11:58
      - extra-reference design: R code BEQool 2025-12-29 14:17
        
        extra-reference design: no period effect assumption mittyri 2025-12-29 22:16
        
        extra-reference design: no period effect assumption BEQool 2025-12-31 16:42

Robustness of bioequivalence when 90%CI doesn’t include 1 Darborn 2025-12-23 08:55 [Study Assessment]
- statistical significance ≠ clinical relevance Helmut 2025-12-23 13:52
  - statistical significance ≠ clinical relevance Darborn 2025-12-24 01:07
    - Δ (20% in general) Helmut 2025-12-24 09:59

Zonisamide Concentration in human Serum shreyas goswami 2025-12-15 05:52 [Bioanalytics]

Carry over and statistical adjustment in BE computations Achievwin 2023-10-02 20:34 [General Statistics]
- Carry-over → 🚮 Helmut 2023-10-02 21:06
  - Carry-over → 🚮 Achievwin 2023-10-03 12:13
    - Carry-over → 🚮 Helmut 2023-10-03 12:48
    - Carry-over dshah 2023-10-03 16:34
      - Carry-over Achievwin 2023-10-03 20:33
        
        Carry-over Helmut 2023-10-04 08:31
        
        Carry-over Achievwin 2023-10-04 16:38
        
        Carry-over dshah 2023-10-04 11:22
      - more than 20% subject carry over effect investigation mittyri 2023-10-05 20:15
      - carry over effect investigation based on what? Helmut 2023-10-06 07:08
        
        carry over effect investigation based on what? dshah 2023-10-06 13:20
    - Carry-over → 🚮 Mahmoud 2025-12-09 10:47
      - Carry-over → 🚮 Helmut 2025-12-10 10:38
        
        Carry-over → 🚮 Mahmoud 2025-12-11 05:11
- Outdated and wrong answers mittyri 2023-10-05 20:34
  - Wrong answer Helmut 2023-10-06 07:19

Data for MSc Thesis on Bioequivalence Obinoscopy 2025-12-07 14:59 [General Statistics]
- Data for MSc Thesis on Bioequivalence Helmut 2025-12-08 13:12
  - Data for MSc Thesis on Bioequivalence Obinoscopy 2025-12-08 20:57
    - Data for MSc Thesis on Bioequivalence Helmut 2025-12-10 11:13
- Data for MSc Thesis on Bioequivalence paulhurleyuk 2025-12-09 18:19

Deferasirox fast study mokhtar saleh 2025-12-04 18:52 [Regulatives / Guidelines]

ICH M12 Drug Interaction Studies: Determination of No-Effect Boundaries BEQool 2025-11-26 11:58 [Regulatives / Guidelines]
- Filgotinib DDI? mittyri 2025-11-27 12:02
  - Filgotinib DDI? BEQool 2025-12-02 14:09

Question about ICH M13a jag009 2025-11-19 20:29 [Regulatives / Guidelines]
- Question about ICH M13a Relaxation 2025-11-20 08:47
- Question about ICH M13a Shuanghe 2025-11-20 13:59
- Question about ICH M13a jag009 2025-11-20 23:47
  - ICH M13A if >2 treatments Helmut 2025-11-23 11:26
    - ICH M13A if >2 treatments jag009 2025-11-23 22:37

EMA: Draft GL on non-inferiority and equivalence Helmut 2025-11-17 10:05 [BE/BA News]

Visual inspection of fits (estimation of λ-z) Helmut 2025-11-15 12:36 [NCA / SHAM]
- Visual inspection of fits (estimation of λ-z) ElMaestro 2025-11-15 19:10
  - Wetware 🧠 vs. software 🤖 Helmut 2025-11-16 09:21
  - Manual integrations Ohlbe 2025-11-17 08:32
    - Manual int ElMaestro 2025-11-17 09:35

September trouble ElMaestro 2025-11-10 12:26 [🇷 for BE/BA]
- September trouble mittyri 2025-11-10 20:38
- More months trouble Helmut 2025-11-11 09:37
  - More months trouble ElMaestro 2025-11-13 05:20
    - Know the month abbreviations Helmut 2025-11-13 12:45
      - Know the month abbreviations ElMaestro 2025-11-14 16:34
- Worse in France Ohlbe 2025-11-12 15:13
  - Worse in France ElMaestro 2025-11-14 16:38

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