Bioequivalence and Bioavailability Forum

Two-stage BE study Achievwin 2020-06-17 15:12 [Design Issues]
- Two-stage BE study jag009 2020-06-18 07:06

IVIVC calculations mahendra 2013-10-24 16:10 [Dissolution / BCS / IVIVC]
- IVIVC calculations yjlee168 2013-10-24 19:22
  - IVIVC calculations mahendra 2013-10-24 19:45
    - IVIVC calculations yjlee168 2013-10-24 22:21
      - Mergers Helmut 2013-10-25 14:38
      - IVIVC calculations mahendra 2013-10-25 16:49
        
        PCDCON ⇒ IVIVC calculations yjlee168 2013-10-27 05:41
      - IVIVC calculations thalita_m 2019-06-18 02:51
- IVIVC calculations jag009 2013-10-24 23:17
  - Minitab etc. Helmut 2013-10-25 14:43
    - Minitab etc. jag009 2013-10-25 16:27
      - XL Helmut 2013-10-25 16:38
        
        XL jag009 2013-10-28 20:42
        
        XL luvblooms 2013-10-29 05:08
        
        XL jag009 2013-10-29 15:07
        
        XL luvblooms 2013-10-30 07:00
        
        Broken link Helmut 2013-10-30 14:40
        XL jag009 2013-10-30 16:35
        
        XL luvblooms 2013-10-31 08:15
        
        XL jag009 2013-10-31 20:31
        Any news? jag009 2013-11-06 16:44
        
        Good News luvblooms 2013-11-07 10:50
        
        PBPK IVIVC jag009 2013-11-27 16:44
        
        PBPK IVIVC luvblooms 2013-11-27 19:31
        
        PBPK IVIVC jag009 2013-11-27 20:04
        
        Good News jag009 2013-11-28 06:01
        
        Contact Helmut 2013-11-07 14:50
        
        Contact jag009 2013-11-27 16:42
        
        XL thalita_m 2019-06-18 02:46
        
        Jean-Michel Helmut 2019-06-18 11:08
        
        Jean-Michel thalita_m 2019-06-20 22:18
        
        Jean-Michel Abel1972 2020-06-17 05:28
    - Minitab etc. Achievwin 2020-06-17 15:00
  - IVIVC calculations mahendra 2013-10-25 16:48
- IVIVC calculations vinayshed 2013-10-28 08:54

Stability of IPs Loky do 2020-06-10 13:31 [GxP / QC / QA]
- Stability of IPs ElMaestro 2020-06-10 18:17
  - Stability of IPs Loky do 2020-06-16 13:24

AUCt not covering at least 80% of AUCinf ratnakar1811 2013-03-05 08:30 [Regulatives / Guidelines]
- 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

Bracketing Approach Helmut 2020-06-12 12:12 [Power / Sample Size]

Pre-Dose sample required to steady state Roy 2020-06-12 08:44 [Regulatives / Guidelines]
- Achievement of steady state Helmut 2020-06-12 10:17

How to analyze bioavailable of single arm data comparing a historical control libaiyi 2020-06-09 07:48 [Design Issues]
- Dazed and confused Helmut 2020-06-09 16:57
- Bridging study? d_labes 2020-06-11 18:27

Inclusion criteria in BE studies Loky do 2020-05-22 18:16 [Design Issues]
- BE: ♀♂ Helmut 2020-05-23 17:12
- Inclusion criteria in BE studies jag009 2020-05-25 07:43
  - Stratify for sex? Helmut 2020-05-25 12:48
    - Stratify for sex? jag009 2020-05-25 21:10
- Inclusion criteria in BE studies ElMaestro 2020-05-25 14:39
  - Inclusion criteria in BE studies Loky do 2020-06-10 13:19

Dextromethorphan Rosy 2020-03-21 23:38 [Study Performance]
- Dextromethorphan pmohite 2020-06-08 08:49

BE study in China (for China) jag009 2020-06-04 17:50 [Regulatives / Guidelines]
- BE study in China (for China) Shuanghe 2020-06-05 10:56
  - BE study in China (for China) jag009 2020-06-05 18:41

Regarding used normal Two-way crossover program was used for un-scaled average Sivakrishna 2020-06-01 11:47 [Study Assessment]
- (2×2×2?) ANOVA instead of mixed model Helmut 2020-06-01 15:08

Bioequivalence for Parenteral Products arailkar 2020-05-29 17:21 [Regulatives / Guidelines]
- T = EV ∧ R = IV ¬ BE (→ absolute BA) Helmut 2020-05-29 17:51

Simulations 101 Helmut 2020-05-26 23:47 [Power / Sample Size]
- Simulations 101 d_labes 2020-05-27 19:30
  - Simulations 101 Helmut 2020-05-27 21:06
    - Simulations 101 d_labes 2020-05-28 18:34
- More about the tables Helmut 2020-05-29 13:30

PK study in infants jag009 2020-05-28 21:18 [Regulatives / Guidelines]

NTI Drug jag009 2020-05-28 21:14 [Regulatives / Guidelines]