Bioequivalence and Bioavailability Forum

Recommendations to bioequivalence study of Rivaroxaban: FDA vs EMA Mauricio Sampaio 2017-07-19 16:55

Bioequivalence study of class II molecule bhargavj12 2017-07-10 19:59
- BE of Schedule II drug (India) Helmut 2017-07-10 20:21
  - BE of Schedule II drug (India) bhargavj12 2017-07-11 06:05
    - BE of Schedule II drug (India) jag009 2017-07-14 05:52

FDA BE Guide Warfarin – never used? nobody 2017-07-13 15:13
- FDA BE Guide Warfarin – never used? Helmut 2017-07-13 16:53
  - FDA BE Guide Warfarin – never used? nobody 2017-07-13 19:00
    - Sample sizes are not prohibitive Helmut 2017-07-13 19:54
      - Sample sizes are not prohibitive nobody 2017-07-13 20:12
        
        Sample sizes are not prohibitive Helmut 2017-07-13 20:36

Highly Variable Drug BE Justification jag009 2017-03-20 04:42
- Highly Variable Drug BE Justification ElMaestro 2017-03-20 06:55
  - Study costs: Replicate vs. 2×2×2 Helmut 2017-03-20 13:12
    - Study costs: Replicate seems to be cheaper VStus 2017-03-21 12:49
      - Study costs: Replicate seems to be cheaper Dr_Dan 2017-03-21 13:06
        
        Study costs: Replicate seems to be cheaper Helmut 2017-03-21 14:50
        
        expected power d_labes 2017-03-21 15:16
        Doesn't hurt! VStus 2017-03-23 14:24
    - Study costs: Replicate vs. 2×2×2 mahmoud-teaima 2017-03-23 08:17
    - Study costs: Replicate vs. 2×2×2 M.tareq 2017-05-07 21:21
      - Replicate vs. 2×2×2 (ethics?) Helmut 2017-05-08 14:21
        
        Replicate vs. 2×2×2 (ethics?) nobody 2017-05-08 14:52
        
        Applicability of reference-scaling Helmut 2017-05-10 14:10
        
        Replicate vs. 2×2×2 M.tareq 2017-05-14 23:04
        
        Replicate vs. 2×2×2 Helmut 2017-05-15 19:07
        
        Replicate vs. 2×2×2 M.tareq 2017-05-15 21:02
        Regulators view of HVD drugs DavidManteigas 2017-05-16 12:41
        
        Regulators view of HVD drugs Helmut 2017-05-16 15:01
        What's the problem? ElMaestro 2017-05-17 03:30
        
        What's the problem? nobody 2017-05-17 07:48
        
        What's the problem? nobody 2017-05-17 09:31
        
        What's the problem? DavidManteigas 2017-05-17 11:25
        
        What's the problem? ElMaestro 2017-05-17 12:07
        
        What's the problem? kumarnaidu 2017-07-11 14:43
        
        What's the problem? ElMaestro 2017-07-11 14:56

Russian BE requirement Rasha_J 2016-05-15 10:39
- Russian BE requirement mittyri 2016-05-18 07:09
- Russian BE requirement Beholder 2016-05-19 15:25
  - Russian BE requirement Rasha_J 2017-06-06 11:27
    - Russian BE requirement Marika 2017-06-06 19:20
      - List of accredited clinical sites Helmut 2017-06-06 23:55
      - Russian BE requirement Beholder 2017-06-07 16:23
      - Russian BE requirement Beholder 2017-06-23 10:13

LIMS Rasha_J 2017-06-06 11:51
- LIMS Helmut 2017-06-06 13:20

Incurred sample reanalysis sushil.pimpare 2017-06-06 07:53
- Incurred sample reanalysis ElMaestro 2017-06-06 10:20
- Incurred sample reanalysis Ohlbe 2017-06-06 12:10

change in CC range sushil.pimpare 2017-05-31 09:31
- exact matching of CCs (validation’s and study’s) Helmut 2017-05-31 12:41
  - exact matching of CCs (validation’s and study’s) nobody 2017-05-31 13:43
    - exact matching of CCs (validation’s and study’s) sushil.pimpare 2017-05-31 14:01
      - exact matching of CCs (validation’s and study’s) ElMaestro 2017-05-31 14:11
      - exact matching of CCs (validation’s and study’s) nobody 2017-05-31 15:38
  - exact matching of CCs (validation’s and study’s) sushil.pimpare 2017-05-31 13:46
    - Sapere aude! Helmut 2017-05-31 14:46

CDISC domains arl_stat 2017-05-17 08:42
- CDISC domains DavidManteigas 2017-05-17 10:28
  - CDISC domains arl_stat 2017-05-20 08:41

Pharmacokinetic parameters CL, Vd and F mmw 2017-05-06 11:07
- Pharmacokinetic metrics CL, Vd and F Helmut 2017-05-06 12:14
  - Pharmacokinetic metrics CL, Vd and F Shuanghe 2017-05-08 16:16
    - CFDA 2016 BE-GL Helmut 2017-05-09 13:52
      - CFDA 2016 BE-GL Shuanghe 2017-05-10 13:03
        
        nonlinear PK: highest dose ⇔ strength Helmut 2017-05-10 15:17
        
        highest dose ⇔ strength for dummies d_labes 2017-05-10 15:41
        
        highest dose ⇔ strength for dummies Helmut 2017-05-10 15:45
        
        highest dose ⇔ strength for dummies d_labes 2017-05-10 16:20
        
        highest dose ⇔ strength for dummies Helmut 2017-05-10 16:28
        
        highest dose ⇔ strength for dummies d_labes 2017-05-11 16:31
        highest dose ⇔ strength for dummies mmw 2017-05-15 06:53

ANVISA and Malaysian authorities invitation to audit CRO Rasha_J 2016-11-01 09:07
- ANVISA and Malaysian authorities invitation to audit CRO Dr_Dan 2016-11-02 15:13
  - ANVISA and Malaysian authorities invitation to audit CRO Rasha_J 2017-05-11 06:58

endogenous compounds martin 2017-05-08 19:50
- endogenous compounds Helmut 2017-05-08 21:10
  - endogenous compounds martin 2017-05-08 21:19

Narrow Therapeutic Index- valproic acid and derivatives MaggieSantos 2017-04-26 18:20
- Narrow Therapeutic Index- valproic acid and derivatives DavidManteigas 2017-05-02 12:07

Rationale for Partial AUCs in Naloxone hydrochloride nasal spray BE study Gowthami 2017-04-25 12:13
- Rationale for Partial AUCs in Naloxone hydrochloride nasal spray BE study nobody 2017-04-25 13:31

Regarding Statistical criteria for BE study of anticoagulant molecule suchit_bhavsar 2017-04-24 07:29
- Critical dose drugs d_labes 2017-04-24 11:26
  - Critical dose drugs suchit_bhavsar 2017-04-24 12:04
    - Critical dose drugs - FDA highly variable NTID d_labes 2017-04-25 08:41