Bioequivalence and Bioavailability Forum

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

ICHM13A/Multiple Test Product Studies Mikkabel 2025-11-04 09:46 [Regulatives / Guidelines]
- 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

Comparing two plasma concentration profiles Darborn 2025-10-17 05:40 [Study Assessment]
- 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

New ICH M13a guidance on BE analysis jag009 2025-10-17 21:04 [Regulatives / Guidelines]
- ICH M13A (EMA, FDA, HC) Helmut 2025-10-18 12:24

long half-life AUC0-t or AUC0-72 Darborn 2025-10-14 05:34 [NCA / SHAM]
- IR with t½ ≥ 24 h Helmut 2025-10-14 10:30
  - IR with t½ ≥ 24 h Darborn 2025-10-16 06:05
    - long half life product? Helmut 2025-10-16 08:13
      - long half life product? Darborn 2025-10-17 05:16
- long half-life AUC0-t or AUC0-72 ElMaestro 2025-10-15 17:41
  - long half-life AUC0-t or AUC0-72 Darborn 2025-10-16 06:00

Point Estimate consideration in sample size estimate kimhuang 2025-10-09 07:21 [Power / Sample Size]
- Point Estimate consideration in sample size estimate Helmut 2025-10-14 12:33
  - Point Estimate consideration in sample size estimate kimhuang 2025-10-15 00:53
    - BE = CI within acceptance range (PE is irrelevant) Helmut 2025-10-15 09:32
      - BE = CI within acceptance range (PE is irrelevant) ElMaestro 2025-10-15 10:07
        
        BE = CI within acceptance range (PE is irrelevant) kimhuang 2025-10-16 09:37
      - BE = CI within acceptance range (PE is irrelevant) kimhuang 2025-10-16 08:26

Can we administer generic drug as concomitant in patient based PK study narra1813 2025-10-14 13:20 [Regulatives / Guidelines]

Bug in function power.TOST() Helmut 2025-08-22 10:28 [🇷 for BE/BA]
- Bug in function power.TOST() ElMaestro 2025-08-23 09:46
  - Bug in function power.TOST() Helmut 2025-08-23 11:01
    - Bug in function power.TOST() fixed d_labes 2025-10-06 09:59

Guideline on the requirements for demonstrating Therapeutic equivalence between orally inhaled products (OIP) for asthma qualityassurance 2025-09-25 07:41 [Regulatives / Guidelines]

Sequences of BE study under both fasting and fed studies A.Shtaiwi 2025-09-03 12:40 [Design Issues]
- Sequences of BE study under both fasting and fed studies ElMaestro 2025-09-04 08:05
  - Sequences of BE study under both fasting and fed studies A.Shtaiwi 2025-09-07 05:52
- Fed → fasting Helmut 2025-09-04 08:26
  - Fed (failed) → fasting (succeeded) mittyri 2025-09-22 11:01
    - Fed (failed) → fasting (succeeded) Helmut 2025-09-23 15:35

Introduction into basic principles of clinical PK Helmut 2025-09-18 09:53 [Conferences / Workshops]

Phoenix: What to do if pre-dose is greater than the peak conc jag009 2025-09-16 04:29 [Software]
- Phoenix: Data please! Helmut 2025-09-16 21:51

Batch acceptance with revised LLOQ shreyas goswami 2025-08-19 04:22 [Bioanalytics]
- Interference in blanks Ohlbe 2025-08-22 08:14
- Batch acceptance with revised LLOQ ElMaestro 2025-09-12 10:28

Lupron shelf life or expiration date Achievwin 2025-08-08 12:25 [Regulatives / Guidelines]
- Lupron shelf life or expiration date Helmut 2025-08-10 07:18
  - Lupron shelf life or expiration date Achievwin 2025-08-11 14:45
    - Shelf-life 🇦🇹 🇳🇿 (similar in 🇪🇺?) Helmut 2025-08-11 15:48
      - Shelf-life 🇦🇹 🇳🇿 (similar in 🇪🇺?) Achievwin 2025-08-14 12:09
        
        Shelf-life (≠ Lupron!) Helmut 2025-08-14 15:25

Admin contact
23,655 posts in 4,993 threads, 1,572 registered users;
152 visitors (0 registered, 152 guests [including 35 identified bots]).
Forum time: 02:54 CEST (Europe/Vienna)

Scientists cannot simply hang their subjectivities
up on a hook outside the laboratory door. Ruth Bleier

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz