Bioequivalence and Bioavailability Forum

ICH M9 - reverse engineering? MSimoes 2020-09-16 16:01
- ICH M9 - reverse engineering? dshah 2020-09-17 06:46
  - ICH M9 - reverse engineering? MSimoes 2020-09-17 15:56
    - ICH M9 - reverse engineering? dshah 2020-09-30 07:27

Bioequivalence Limit, Power and interpretation Pharma_88 2020-09-22 13:27
- Bioequivalence Limit, Power and interpretation Helmut 2020-09-22 13:59
- Power and sensitivity analyses Helmut 2020-09-25 13:42

Retention for multicenter patient BABE study pash413 2020-09-06 17:43
- Retention for multicenter patient BABE study Achievwin 2020-09-14 14:21

EMA: Waiving MD study Helmut 2020-09-09 16:21
- EMA: Waiving MD study wienui 2020-09-09 17:43
  - EMA: Waiving MD study Helmut 2020-09-09 19:26
- PK model PharmCat 2020-09-10 20:12
  - Zero order helps often Helmut 2020-09-10 22:26
    - Zero order helps often PharmCat 2020-09-11 02:33
      - Distributed delay mittyri 2020-09-11 05:31

Design Pharma_88 2020-08-27 16:07
- Jurisdiction? Helmut 2020-08-27 17:32
  - Jurisdiction? Pharma_88 2020-08-31 10:26
    - EMA: ABEL for HVD(P)s, PK metrics Helmut 2020-08-31 12:21
      - EMA: ABEL for HVD(P)s, PK metrics Pharma_88 2020-09-08 09:05
        
        EMA: MD PK metrics Helmut 2020-09-08 17:25

Document Retention Period for Bioequivalence study Turkish Submission yatish gosai 2020-08-10 14:36
- Website of the Turkish Medicines and Medical Devices Agency Helmut 2020-08-10 15:15
- Document Retention Period for Bioequivalence study Turkish Submission Brus 2020-08-31 14:21
  - Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? Obinoscopy 2020-09-01 01:50
    - Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? Brus 2020-09-01 09:06
      - ICH = 2 Years after last approval based on study Ohlbe 2020-09-01 11:03

bioequivalence of vit D3 cholecalciferol khaoula 2020-08-18 12:41

long half-life and large variability martin 2020-07-29 16:57
- long half-life and large variability ElMaestro 2020-07-29 21:24
  - long half-life and large variability martin 2020-07-29 22:49
    - long half-life and large variability ElMaestro 2020-07-30 08:17
      - long half-life and large variability dshah 2020-08-10 06:18
- long half-life and large variability Achievwin 2020-08-12 15:22
  - long half-life and large variability Helmut 2020-08-12 15:53

Favipiravir Bioanalysis Ayman Rabayah 2020-08-11 08:44
- Homework Helmut 2020-08-11 11:35
  - Homework Ayman Rabayah 2020-08-12 07:56
    - “Shlonak” Helmut 2020-08-12 12:57

USFDA guidance for petitioned ANDA shahajan baig 2020-07-20 21:50

CDISC in China? jag009 2020-07-16 19:46

Requirements for different pharmaceutical forms or dosages Mauricio Sampaio 2020-07-13 13:52
- Homework ;-) Helmut 2020-07-13 17:25

Transdermal Kelen 2020-06-29 18:51

steady state for modified release Kelen 2019-09-20 20:04
- steady state for modified release Helmut 2019-09-23 10:04
  - steady state for modified release apapanas 2020-06-24 14:25
    - Superposition principle Helmut 2020-06-24 14:38
      - Superposition principle apapanas 2020-06-24 15:32

AUCt not covering at least 80% of AUCinf ratnakar1811 2013-03-05 08:30
- AUCt not covering at least 80% of AUCinf d_labes 2013-03-05 11:12
  - AUCt not covering at least 80% of AUCinf ratnakar1811 2013-03-06 08:50
    - AUCt not covering at least 80% of AUCinf ElMaestro 2013-03-06 11:10
      - ADME-tox? Helmut 2013-03-06 14:35
        
        ADME-tox? ElMaestro 2013-03-06 16:40
        
        OT Helmut 2013-03-06 17:19
        
        OT ElMaestro 2013-03-07 17:19
        
        OT Helmut 2013-03-07 17:26
    - Science vs. regulations Helmut 2013-03-06 14:30
      - Science vs. regulations cakhatri 2013-03-10 08:59
        
        ratio = difference of logs! Helmut 2013-03-11 01:17
      - Science vs. (EMA) GL aka PK primer Helmut 2013-03-11 03:17
      - Science vs. regulations qualityassurance 2020-04-23 14:11
        
        Science vs. regulations Helmut 2020-04-23 17:32
        
        Science vs. regulations Achievwin 2020-05-07 22:59
        
        Science vs. regulations Helmut 2020-05-07 23:54
    - AUCt not covering at least 80% of AUCinf Brus 2018-11-20 13:01
      - AUCt not covering at least 80% of AUCinf Astea 2020-06-05 19:05
        
        So what? Helmut 2020-06-06 12:02
        
        Carrot and whip Astea 2020-06-06 21:11
        
        Gedankenexperiment Helmut 2020-06-07 12:41
        
        Dead dogs mittyri 2020-06-07 20:32
        
        Aber meine Herren das ist keine physik Astea 2020-06-08 00:08
        
        Aber meine Dame, das ist alles Unsinn! Helmut 2020-06-08 01:04
        Bizarre paper Helmut 2020-06-08 12:43
        
        Bizarre paper ElMaestro 2020-06-08 15:33
        
        OT: Bias of AUCt, AUCall, pAUC Helmut 2020-06-08 15:53
        
        OT: Bias of AUCt, AUCall, pAUC ElMaestro 2020-06-09 08:45
        
        OT: Bias of AUCs; example Helmut 2020-06-09 14:07
        
        Maxwell's demon Astea 2020-06-12 14:15
        
        Dead dogs Helmut 2020-06-08 10:40