Bioequivalence and Bioavailability Forum

New FDA guidances Ohlbe 2026-06-01 17:04

Sample size with theta0 < 0.95: any regulatory pushback? Martynkf 2026-05-12 13:23
- Sample size with theta0 < 0.95: Why not? Helmut 2026-05-12 14:55
  - Repeating Studies zizou 2026-05-22 16:11
    - Buongiorno, signor Bonferroni! Helmut 2026-05-23 08:30
      - Buongiorno, signor Bonferroni! ElMaestro 2026-05-25 17:13
- Sample size with theta0 < 0.95: any regulatory pushback? ElMaestro 2026-05-13 01:26
  - Sample size with theta0 < 0.95: any regulatory pushback? Martynkf 2026-05-13 08:27
    - More information, please Helmut 2026-05-13 08:53
      - More information, please Martynkf 2026-05-13 10:27
        
        Still 🤔 Helmut 2026-05-13 13:25
        
        Still 🤔 Martynkf 2026-05-15 08:02

Dataset requirement for UK and EU jag009 2026-05-18 06:23
- Dataset requirement for UK and EU Helmut 2026-05-18 08:25
  - Dataset requirement for UK and EU jag009 2026-05-18 14:05
    - Dataset requirement for UK and EU Helmut 2026-05-18 14:31
      - Dataset requirement for UK and EU jag009 2026-05-18 14:55
    - Inf File zizou 2026-05-22 16:49

Single study with two different RLD / Submission Pharma_88 2026-04-30 04:46
- Single study with two different RLD / Submission Helmut 2026-04-30 08:50

Amoxicillin powder for suspension 125 mg/5ml and 250 mg/5ml BE studies for Canada bebacrk 2026-04-14 08:25
- ICH M13A implemented in Canada Helmut 2026-04-15 11:31

NDA and ANDA Bio study NK 2026-03-13 06:26
- NDA and ANDA Bio study dshah 2026-03-18 06:01
  - NDA and ANDA Bio study NK 2026-03-20 06:18

Bioequivalence concluded only in AUC Brus 2026-02-25 13:39
- Bioequivalence concluded only in AUC dshah 2026-02-26 08:44

Truncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Product A.Shtaiwi 2026-02-02 08:32
- Truncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Product dshah 2026-02-18 07:04

is open label study acceptable for Canada after implementation of ICH M13A bebacrk 2026-02-12 05:14
- HC: open label studies acc. to ICH M13A Helmut 2026-02-12 09:03
  - HC: open label studies acc. to ICH M13A bebacrk 2026-02-12 09:53
    - HC: outliers in replicate designs? Helmut 2026-02-13 10:33

Venetoclax film-coated tablets study requirement gsrao2022 2026-01-16 16:21
- Venetoclax film-coated tablets study requirement A.Shtaiwi 2026-02-02 08:46

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

Deferasirox fast study mokhtar saleh 2025-12-04 18:52

ICH M12 Drug Interaction Studies: Determination of No-Effect Boundaries BEQool 2025-11-26 11:58
- 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
- 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

ICHM13A/Multiple Test Product Studies Mikkabel 2025-11-04 09:46
- α-adjustments? Helmut 2025-11-04 11:15
  - α-adjustments? Mikkabel 2025-11-04 12:03
    - α-adjustments? BEQool 2025-11-09 20:08
      - Beyond Bonferroni… Helmut 2025-11-10 08:56

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