Bioequivalence and Bioavailability Forum

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

software for calculating sample size for replicate bioequivalence studies gsrao2022 2024-09-24 17:21 [Power / Sample Size]
- 🇷 package PowerTOST Helmut 2024-09-24 19:33

ICH M13A: Changes to Step 2 Helmut 2024-07-31 13:16 [BE/BA News]
- ICH M13A: Changes to Step 2 Helmut 2024-07-31 14:19
  - AUCres mittyri 2024-08-05 21:08
    - ‘Percentage covered’ Helmut 2024-08-05 22:13
  - ICH M13A: Changes to Step 2 BEQool 2024-09-09 05:48
    - fixed or mixed effects model Helmut 2024-09-09 07:04
      - fixed or mixed effects model BEQool 2024-09-09 10:18
        
        fixed or mixed effects model Helmut 2024-09-09 11:13
        
        fixed or mixed effects model BEQool 2024-09-10 07:35
      - fixed or mixed effects model Helmut 2024-09-10 08:12
- ICH M13A: Changes to Step 2 Helmut 2024-08-05 12:53
- period within group and formulation mittyri 2024-08-05 20:42
  - period within group and formulation Helmut 2024-08-05 22:29
- ICH M13A: Step 4 → 5 Helmut 2024-08-08 11:57
  - Formal ICH Procedure Helmut 2024-08-09 09:45
- ICH M13A: Changes to Step 2 Helmut 2024-09-06 08:04

error JFSR jforbital 2024-09-09 03:18 [🇷 for BE/BA]
- package scales ≥1.3.0 Helmut 2024-09-09 11:49

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

risperidone AND water Bebac user 2024-09-04 18:51 [Design Issues]
- ODT vs IR Helmut 2024-09-05 11:57
- risperidone AND water dshah 2024-09-06 06:15

Problem with bear 2.9.1 Balu 2024-08-30 05:42 [🇷 for BE/BA]
- Problem with bear 2.9.1 Helmut 2024-08-30 08:14
  - Problem with bear 2.9.1 Balu 2024-08-31 06:28
    - Did you try? Helmut 2024-08-31 08:27
      - Did you try? Balu 2024-09-04 10:38
        
        Perseverance… Helmut 2024-09-04 11:43
        
        Perseverance… Balu 2024-09-04 11:48
        
        Getting tired 😴 Helmut 2024-09-04 14:12

EMA: ICH M13A coming into effect 25 January 2025 Helmut 2024-09-04 11:30 [BE/BA News]

Simulation-based 2×2×2 TSDs – a deep dive Helmut 2024-09-03 13:18 [Two-Stage / GS Designs]

Cholestyramine and colesevelam in Vitro binding studies jansari 2024-09-02 17:25 [Regulatives / Guidelines]

Compound highly variable Laura Carreiras 2024-08-28 08:20 [Design Issues]
- Always full (!) replicate pilot for reference-scaling Helmut 2024-08-28 11:25
  - Always full (!) replicate pilot for reference-scaling Laura Carreiras 2024-09-02 13:52

A rant Helmut 2024-08-26 12:52 [Two-Stage / GS Designs]
- A rant Achievwin 2024-08-28 02:16
  - Parallel (replicate?) Helmut 2024-08-28 10:54

A dumb question jag009 2024-08-12 13:17 [Bioanalytics]
- A dumb answer Helmut 2024-08-12 13:45
  - A dumb answer jag009 2024-08-12 14:35
    - A dumb answer Helmut 2024-08-12 15:01
      - A dumb answer ElMaestro 2024-08-12 15:13
        
        A dumb answer Helmut 2024-08-12 15:30
- An alternate dumb answer Ohlbe 2024-08-12 21:37
  - An alternate dumb answer jag009 2024-08-13 06:27
  - Unconjugated ≠ free Helmut 2024-08-13 07:31
    - Unconjugated ≠ free jag009 2024-08-26 16:19
- A dumb question Achievwin 2024-08-27 03:02

Leuprolide 1 month product shelf life Achievwin 2024-08-27 02:47 [Design Issues]

Acute and Sub-acute toxicity studies for FDA ANDAs Achievwin 2024-08-05 18:50 [Regulatives / Guidelines]
- 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

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