Bioequivalence and Bioavailability Forum

CV% and confidence interval Darborn 2024-05-29 08:26 [Software]
- Phoenix WinNonlin vs PowerTOST Helmut 2024-05-29 09:39
  - Phoenix WinNonlin vs PowerTOST Darborn 2024-05-30 01:35
    - Phoenix WinNonlin: Variance estimate → CV, Welch-test Helmut 2024-05-30 09:21
      - Base 🇷 for comparison Helmut 2024-05-30 11:08
        
        Base 🇷 for comparison Darborn 2024-05-31 02:07

Single dose PK study on Patients Pharma_88 2024-05-15 05:37 [Design Issues]
- Single dose PK study on Patients Ohlbe 2024-05-15 09:39
  - Single dose PK study on Patients Pharma_88 2024-05-17 10:06
    - No, sorry Ohlbe 2024-05-17 13:45
      - No, sorry Pharma_88 2024-05-20 06:50
        
        Deviating from a guidance Helmut 2024-05-20 07:57
        
        Deviating from a guidance Pharma_88 2024-05-21 08:32
        
        No, sorry Ohlbe 2024-05-21 12:41

PKNCA calculation of AUC jag009 2024-05-19 23:45 [🇷 for BE/BA]
- PKNCA defaults to the linear-up/log-down rule Helmut 2024-05-20 07:39

Large sample size in a BE study Achievwin 2024-05-03 13:28 [Design Issues]
- My record: ≈400 Helmut 2024-05-03 13:34
  - My record: ≈400 Achievwin 2024-05-03 13:49
    - My record: ≈400 Helmut 2024-05-03 14:19
  - My record: ≈400 nobody 2024-05-03 18:44
    - n=180 4-period full replicate Helmut 2024-05-03 22:25
      - n=180 4-period full replicate Achievwin 2024-05-06 15:56
        
        HVNTID! mittyri 2024-05-07 07:35
      - n=180 4-period full replicate dshah 2024-05-08 16:11
        
        Lousy T/R-ratio Helmut 2024-05-08 16:18
        n=180 4-period full replicate Achievwin 2024-05-17 13:45

A Short History of Bioequivalence Helmut 2024-05-05 13:33 [Off Topic]
- A Short History of Bioequivalence Achievwin 2024-05-08 19:05
  - A Short History of Bioequivalence Helmut 2024-05-08 22:50

Probability of Success in BE studies Achievwin 2024-05-03 13:43 [Design Issues]
- Probability of Success in BE studies Helmut 2024-05-03 14:15
  - Probability of Success in BE studies Achievwin 2024-05-06 14:49
    - Probability of Success in BE studies d_labes 2024-05-06 15:16
      - Probability of Success in BE studies Achievwin 2024-05-06 15:31
    - Assumptions (plural) Helmut 2024-05-06 15:31
      - Assumptions (plural) Achievwin 2024-05-06 15:51

FDA workshop on GLP and BA/BE inspections Ohlbe 2024-04-23 16:39 [Conferences / Workshops]
- Agenda Helmut 2024-05-03 15:34

Orlistat PD Endpoint BE study NK 2024-04-30 04:33 [Regulatives / Guidelines]

Ferrograd Folic 325 mg / 0.35 mg prolonged-release tablet Study Requirement / Analyte to measure JP2030 2024-04-29 07:18 [Design Issues]

Handling and Retention of BA and BE Testing Samples dshah 2024-03-26 17:15 [BE/BA News]
- Handling and Retention of BA and BE Testing Samples Achievwin 2024-04-23 16:16

BioBridges 2024 Helmut 2024-04-23 13:56 [Conferences / Workshops]

EMA: Draft GL for OIPs Helmut 2024-04-19 15:40 [BE/BA News]
- EMA: Draft GL for OIPs Chirag 2024-04-22 04:37
  - EMA: Draft GL for OIPs Ohlbe 2024-04-22 14:07

Sponsor-CRO relationship MDBKV 2024-04-17 05:38 [GxP / QC / QA]
- Sponsor-CRO relationship Ohlbe 2024-04-17 21:34

Parallel Group Adaptive Designs Alex 2023-12-22 10:08 [Two-Stage / GS Designs]
- Strong Type I Error control + CI: Not yet… Helmut 2023-12-22 12:01
  - Strong Type I Error control + CI: Not yet… Alex 2024-01-08 16:22
    - Strong Type I Error control + CI: Not yet… Helmut 2024-01-09 09:48
  - Strong Type I Error control + CI: Not yet… roman_max 2024-04-04 15:18
    - Parallel design: Only simulation-based methods so far Helmut 2024-04-04 20:16
      - Parallel design: Only simulation-based methods so far roman_max 2024-04-15 21:46
- Parallel Group Adaptive Designs Achievwin 2024-01-05 11:53
  - Simulations highly recommended Helmut 2024-01-05 12:40
    - Simulations highly recommended Achievwin 2024-01-08 16:55
      - Simulations mandatory Helmut 2024-01-09 09:31
        
        Simulations mandatory Achievwin 2024-01-09 21:11
        
        Reviews are confidential Helmut 2024-01-09 22:10
        
        Reviews are confidential Achievwin 2024-01-19 15:11
        
        Not accepted and for a reason… Helmut 2024-04-04 20:22
        
        Quod licet Iovi mittyri 2024-04-05 20:33
        
        Non licet bovi Helmut 2024-04-05 21:50
        
        Non licet bovi mittyri 2024-04-05 22:21
        
        Quod licet bove? Helmut 2024-04-06 07:21

The order function ElMaestro 2024-03-24 17:07 [🇷 for BE/BA]
- The order function ElMaestro 2024-03-24 20:31
  - The order function Helmut 2024-03-24 21:12
  - The order function d_labes 2024-03-26 19:58
    - The order function ElMaestro 2024-03-27 08:43
      - The sort function Helmut 2024-04-02 10:51
        
        The sort function ElMaestro 2024-04-02 22:44
        
        lag-times of profiles and cor() Helmut 2024-04-04 09:39
        
        Roaster VII/VIII, Bandana Castor, and Effiou ElMaestro 2024-04-04 12:30
        
        Nomen est omen Helmut 2024-04-04 13:04
        
        Nomen est omen ElMaestro 2024-04-04 13:50
        
        Nomen est omen Ohlbe 2024-04-04 14:52
        
        Nomen est omen ElMaestro 2024-04-04 16:16
        
        Nomen est omen nobody 2024-04-10 09:21
        
        Nomen est omen Ohlbe 2024-04-10 09:34
        
        Nomen est omen nobody 2024-04-10 10:21
        
        Source ElMaestro 2024-04-11 10:50
        
        Source nobody 2024-04-12 11:46
        
        Inquiry Ohlbe 2024-04-12 18:23
        
        Inquiry nobody 2024-04-15 09:54

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