Bioequivalence and Bioavailability Forum

Oxcarbazepine Tablet Study design AB661 2024-07-13 09:02 [Design Issues]
- ABE or ABEL for Health Canada Helmut 2024-07-14 12:17
- Oxcarbazepine Tablet Study design jag009 2024-07-23 19:50
  - Health Canada ABEL Helmut 2024-07-24 09:06
  - Oxcarbazepine Tablet Study design AB661 2024-08-24 11:00
    - Oxcarbazepine Tablet Study design Helmut 2024-08-24 12:19

EU Reference Medicinal Product – Flexible or Absolute? PE 2024-08-20 10:39 [Regulatives / Guidelines]
- EEA Reference Medicinal Product: Mandatory Helmut 2024-08-20 12:17

Predose concentration more than 5 % of Cmax NK 2024-08-05 06:07 [Regulatives / Guidelines]
- FDC or isomers: C0 > 5 % of Cmax Helmut 2024-08-05 08:36
  - FDC or isomers: C0 > 5 % of Cmax Achievwin 2024-08-05 19:08
    - Carryover. A Never Ending Story. Helmut 2024-08-05 22:39
  - Inducers/inhibitors Ohlbe 2024-08-08 18:09
    - Inducers/inhibitors Helmut 2024-08-09 08:26
- Predose concentration more than 5 % of Cmax qualityassurance 2024-08-05 12:48

A boring question about bioavailability? Darborn 2024-08-01 09:05 [Off Topic]
- ƒ of IV = 1 by definition, but… Helmut 2024-08-01 12:05
  - ƒ of IV = 1 by definition, but… Darborn 2024-08-01 12:36
    - IV: Different half-lives? Helmut 2024-08-01 13:43
      - IV: Different half-lives? Darborn 2024-08-02 02:39
        
        IV: Liposome encapsuled drug, pegylated biologic? Helmut 2024-08-02 07:52
        
        IV: Liposome encapsuled drug, pegylated biologic? Darborn 2024-08-06 05:15

Fed conditions → timing of meal zuzanna 2024-07-31 07:54 [Design Issues]
- ICH M13A Helmut 2024-07-31 09:14
  - ICH M13A zuzanna 2024-07-31 10:32
    - ICH M13A published Helmut 2024-07-31 12:21
      - ICH M13A published zuzanna 2024-07-31 13:47
        
        ICH M13A published ElMaestro 2024-07-31 14:14
        
        ICH M13A published zuzanna 2024-08-01 12:49
        
        ICH M13A published qualityassurance 2024-08-02 05:09
        
        ICH M13A published ElMaestro 2024-08-02 15:14
        ICH M13A published zuzanna 2024-08-03 21:16
        
        ICH M13A published qualityassurance 2024-08-05 12:45

SAS code of partial replicate design pa1kumar.anna 2008-12-01 09:51 [Software]
- Etiquette Ohlbe 2008-12-01 10:45
- SAS code for what? d_labes 2008-12-02 09:17
  - partial replicate = 3-period replicate Helmut 2008-12-03 15:42
    - partial replicate = 3-period replicate MGR 2008-12-04 11:19
    - 3-period replicate designs and SAS d_labes 2008-12-04 14:17
      - Extra-reference or partial replicate design d_labes 2008-12-12 10:51
        
        Extra-reference or partial replicate design Helmut 2008-12-12 11:34
        
        Simple minded d_labes 2008-12-12 13:28
        
        Simple minded Helmut 2008-12-12 14:58
        
        SAS and WinNonlin d_labes 2008-12-12 15:44
        
        SAS and WinNonlin Helmut 2008-12-12 16:33
        
        SAS and WinNonlin BEQool 2024-07-29 09:38
        
        Phoenix RSABE-template Helmut 2024-07-29 13:29
        
        Phoenix RSABE-template BEQool 2024-07-29 19:47
        
        CVw in Phoenix RSABE-template Helmut 2024-07-30 09:15
        
        CVw in Phoenix RSABE-template BEQool 2024-07-30 10:56
        
        CVw in Phoenix RSABE-template and PowerTOST CI2CV() Helmut 2024-07-30 11:23
        
        CVw in Phoenix RSABE-template and PowerTOST CI2CV() BEQool 2024-07-31 05:49
        
        General ABE? mittyri 2024-07-31 18:25
        
        General ABE? BEQool 2024-08-01 05:45
        
        Switchability and Prescribability in WinNonlin MGR 2008-12-30 10:12
        
        PBE and IBE in WinNonlin Helmut 2008-12-30 16:04
        
        PBE and IBE in WinNonlin MGR 2008-12-31 07:52
        
        Switchability NPavan 2009-01-12 13:10

FDC with ascorbic acid qualityassurance 2024-07-23 08:08 [Regulatives / Guidelines]
- FDC with ascorbic acid Ohlbe 2024-07-23 09:55
  - FDC with ascorbic acid qualityassurance 2024-07-23 10:13
    - Placebo? Helmut 2024-07-23 12:39
      - Placebo? mittyri 2024-07-23 14:54
        
        🇦🇹 AGES Helmut 2024-07-24 11:16
      - Placebo? qualityassurance 2024-07-24 11:37
        
        Sorry – wrong addressee Helmut 2024-07-24 13:31
        
        lucky mittyri 2024-07-24 16:01

Bizarre offer Helmut 2024-07-05 08:37 [Off Topic]
- A name of the book mittyri 2024-07-05 19:09
  - A name of the book ElMaestro 2024-07-06 06:58
    - A name of the book Helmut 2024-07-06 07:33
  - A name of the book Helmut 2024-07-06 07:09
- Bizarre offer jag009 2024-07-23 19:56

Brazil, Mexico: Proc GLM or Proc Mixed? jag009 2024-07-17 20:29 [Regulatives / Guidelines]
- Brazil, Mexico: Proc GLM? Helmut 2024-07-18 09:01
  - Mexico: new guideline Ohlbe 2024-07-18 09:40
    - Mexico: ABEL Helmut 2024-07-18 10:42
      - Mexico: ABEL NK 2024-07-19 07:30
        
        Mexico: ABEL Helmut 2024-07-19 09:26
        
        Mexico: ABEL jag009 2024-07-23 19:43

Difference between compartmental and Noncompartmental Hari 2007-07-11 09:47 [Software]
- WinNonlin: PK and NCA Helmut 2007-07-11 13:12
- Difference between compartmental and Noncompartmental drshiv 2007-08-15 16:23
  - Difference between compartmental and Noncompartmental Helmut 2007-08-15 22:57
    - Difference between compartmental and Noncompartmental jag009 2012-03-23 15:59
      - Micro ⇒ macro Helmut 2012-03-23 18:24
        
        for Deconvolution fans mittyri 2024-07-23 15:02

FARTSSIE 3.0 Helmut 2024-06-19 14:55 [Software]
- FARTSSIE 3.0 BEQool 2024-07-17 08:15
  - FARTSSIE 3.0: Excel 365 @Win 11 & Excel 2000 (‼) @Win 7 Helmut 2024-07-17 08:47
    - FARTSSIE 3.0: Excel 2021 @Win 10 BEQool 2024-07-17 10:00
      - FARTSSIE 3.0: Excel 2021 @Win 10 Helmut 2024-07-17 10:16
      - Windows GPO mittyri 2024-07-17 13:01
        
        Windows GPO BEQool 2024-07-22 05:16

full replicate study for drug not highly variable - EMA perspective Ankit Parikh 2024-07-11 04:40 [Regulatives / Guidelines]
- EMA: Full replicate study Helmut 2024-07-15 09:13

Need some clarity on eCTD module 5 jag009 2024-07-12 16:04 [Regulatives / Guidelines]

Fed dissolution with 20% glucose yuva 2024-07-11 08:55 [Dissolution / BCS / IVIVC]

How to calculate %dissolved using USP Apparatus 4 (Open loop system)? rezkighassani 2024-07-11 07:50 [Dissolution / BCS / IVIVC]