Bioequivalence and Bioavailability Forum

Repeat BE only for failed analyte qualityassurance 2026-01-16 12:52

Robustness of bioequivalence when 90%CI doesn’t include 1 Darborn 2025-12-23 08:55
- 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

Comparing two plasma concentration profiles Darborn 2025-10-17 05:40
- Comparing two plasma concentration profiles Helmut 2025-10-17 12:51
  - Comparing two plasma concentration profiles Darborn 2025-10-21 01:02
    - Comparing two plasma concentration profiles ElMaestro 2025-10-21 12:39
  - Comparing two plasma concentration profiles Shuanghe 2025-10-29 16:27
    - MathJax Helmut 2025-10-29 17:01
    - Formulas… Helmut 2025-10-30 10:28
      - Formulas… Shuanghe 2025-11-05 14:24
- Negative ƒ2 is possible Helmut 2025-10-30 15:40
  - Interesting, however... ElMaestro 2025-11-03 14:15
  - Negative ƒ2 is possible Darborn 2025-11-07 06:04

ISR Loky do 2024-11-21 12:04
- 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
- 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

reason to exclude volunteer Loky do 2024-11-10 11:52
- FDC: No measurable concentrations of one drug Helmut 2024-11-10 12:33
  - FDC: No measurable concentrations of one drug Loky do 2024-11-10 12:48

Decrease in PSD: Need to repeat BE? qualityassurance 2024-07-02 08:32
- Type-II Variation Helmut 2024-07-02 09:37
  - Type-II Variation: Waive in-vivo study by providing in-vitro data? qualityassurance 2024-07-02 11:29
    - Type-II Variation: Waive in-vivo study by providing in-vitro data? SMA 2024-07-02 16:27
      - Type-II Variation: Waive in-vivo study by providing in-vitro data? Relaxation 2024-07-04 12:19

Half life longer than literature (or well known) half-life jag009 2023-12-06 04:19
- Explain it in the report Helmut 2023-12-06 10:41
  - Explain it in the report jag009 2023-12-06 15:46
    - Don’t worry, be happy! Helmut 2023-12-06 16:30
      - Don’t worry, be happy! jag009 2023-12-07 16:36

Zero Data in Suppositories BE Test Siswanto 2023-08-12 09:18
- Zero Data in Suppositories BE Test dshah 2023-08-14 16:15
  - Zero Data in Suppositories BE Test Siswanto 2023-08-15 02:18
    - Zero Data in Suppositories BE Test dshah 2023-08-15 11:07

Outlier NK 2023-06-27 03:57
- Outlier dshah 2023-06-27 08:42
- Visual inspection of the fit! Helmut 2023-06-27 09:56

Isotretinoin Capsules 40 mg fed studies Venkata Chaitanya Reddi 2023-06-14 10:19
- Isotretinoin Capsules 40 mg fed studies dshah 2023-06-15 08:29
  - Isotretinoin Capsules 40 mg fed studies Venkata Chaitanya Reddi 2023-06-16 04:21
    - Isotretinoin Capsules 40 mg fed studies dshah 2023-06-16 08:27
      - Isotretinoin Capsules 40 mg fed studies Venkata Chaitanya Reddi 2023-06-16 08:48

Linagliptin/Metformin Hydrochloride film-coated tablets Venkata Chaitanya Reddi 2023-06-09 07:18
- Linagliptin/Metformin Hydrochloride film-coated tablets dshah 2023-06-09 11:51
  - Linagliptin/Metformin Hydrochloride film-coated tablets Venkata Chaitanya Reddi 2023-06-09 12:01

AUCtau and Ctau calculation Shatha 2022-08-27 01:36
- SAP? Helmut 2022-08-27 10:24
  - SAP? Shatha 2022-08-27 11:55

BE study results Evaluation Vaibhav 2022-06-14 20:57
- Sample size based on ‘overpowered’ study Helmut 2022-06-14 22:14
  - Sample size based on ‘overpowered’ study Vaibhav 2022-06-15 21:00
    - Sample size based on ‘overpowered’ study dshah 2022-06-16 10:43

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