Bioequivalence and Bioavailability Forum

Regulatory Documents Rajdeep 2010-05-18 06:31

US FDA Form 1572 kiranActimus 2010-05-09 16:47
- US FDA Form 1572 Ohlbe 2010-05-09 22:37
  - US FDA Form 1572 kiranActimus 2010-05-11 06:43
    - US FDA Form 1572 Ohlbe 2010-05-11 09:42
      - US FDA Form 1572 kiranActimus 2010-05-11 10:22

upper limit blood loss maverick 2010-04-27 11:08
- upper limit blood loss Jaime_R 2010-04-27 11:31
- upper limit blood loss suds4u 2010-04-28 09:36

EMA BE guideline - final version Ohlbe 2010-01-28 18:31
- Final version published Helmut 2010-01-29 14:29
  - Final version published ElMaestro 2010-01-29 17:02
    - Statistix Helmut 2010-01-29 17:30
      - Statistix ElMaestro 2010-01-29 18:11
    - Calories ;-) Helmut 2010-01-29 19:22
      - Calories ;-) ElMaestro 2010-01-29 20:43
        
        Calories ;-) Helmut 2010-01-29 21:08
      - Variable calories d_labes 2010-02-01 12:05
    - ANOVA only - no doubts Helmut 2010-02-10 23:41
      - ANOVA only - no doubts ElMaestro 2010-02-12 21:09
  - Final EMA oracle d_labes 2010-02-01 11:53
    - Final EMA oracle Helmut 2010-02-01 12:28
    - Final EMA oracle ElMaestro 2010-02-01 12:50
      - More then two EMA oracles d_labes 2010-02-01 13:30
        
        Less of an issue ElMaestro 2010-02-01 15:29
        
        Less or More of an issue d_labes 2010-02-01 16:53
        
        Less or More of an issue ElMaestro 2010-02-01 17:22
        
        Effective with 1 Aug 2010 Helmut 2010-02-02 00:55
        Bias? ElMaestro 2010-02-04 11:27
        
        Bias? Helmut 2010-02-05 02:03
        
        Bias? ElMaestro 2010-02-05 09:33
        
        Bias? Helmut 2010-02-05 10:21
        
        Bias? d_labes 2010-02-05 13:59
        Bias? ElMaestro 2010-02-05 16:00
        
        Bias? Helmut 2010-02-05 19:14
      - Final EMA oracle Helmut 2010-02-01 13:43
        
        Final EMA oracle ElMaestro 2010-02-01 14:54
        
        Final EMA oracle d_labes 2010-02-01 15:20
        
        Teaching Helmut 2010-02-01 16:07
  - Cmin really gone? tmax reappeared? d_labes 2010-02-01 14:02
    - Cmin really gone. tmax reappeared - but how? Helmut 2010-02-01 23:30
  - Interpol or not d_labes 2010-02-01 14:52
    - Interpol! Helmut 2010-02-02 00:02
      - Interpol! ray_be 2010-02-03 18:31
        
        WinNonlin/Phoenix extrapolation to t=tau Helmut 2010-02-03 20:26
  - Meta-analysis Helmut 2010-02-07 17:41
  - Final version published Panks.79 2010-03-08 07:22
    - Cmin for MR-formulations? Helmut 2010-03-08 18:16
      - Cmin for MR-formulations? Marcel 2010-04-23 10:09
        
        MR-Guideline? Helmut 2010-04-23 12:34
- Overview of comments published Helmut 2010-02-10 18:33
  - Comments commented d_labes 2010-02-11 08:19
  - Definition of Cmin by EMEA Ravi 2010-03-13 12:05
    - The EMA’s Cmin & WinNonlin Helmut 2010-03-13 12:52

IM injection ray_be 2010-03-24 06:32
- IM injection Dr_Dan 2010-04-14 10:48
- IM injection ElMaestro 2010-04-14 12:15
  - IM injection ray_be 2010-04-14 13:02
    - IM injection ElMaestro 2010-04-14 13:45
      - IM: absorption site! Helmut 2010-04-14 18:35
        
        IM: absorption site! Ohlbe 2010-04-15 00:40
        
        IM: absorption site! Helmut 2010-04-15 09:15
        IM: absorption site! ElMaestro 2010-04-15 09:39
        
        IM: absorption site! ray_be 2010-04-17 06:20
        
        IM: absorption site! ray_be 2010-04-17 06:25
        
        Quality of the questions asked. Helmut 2010-04-17 22:20

ISR Shastris 2010-04-14 06:13
- ISR vajra123 2010-04-14 06:21
  - ISR Shastris 2010-04-14 15:21
    - ISR vajra123 2010-04-15 05:07
      - ISR Shastris 2010-04-16 10:06

Blinded QC samples IK 2010-04-12 05:46
- Blinded QC samples Helmut 2010-04-12 14:55
  - Blinded QC samples IK 2010-04-13 05:05

Vitamin K2-Menaquinone 7 Rajdeep 2010-04-05 11:46

pk parameters shri 2010-04-03 11:50
- Malaysia, PK metrics Helmut 2010-04-03 15:10
  - Malaysia, PK metrics shri 2010-04-05 07:44

three consecutive missing samples yuvrajkatkar 2010-04-03 08:40
- 1. Science, 2. Guidelines Jaime_R 2010-04-03 14:14

ANVISA guidance Priyanka_S 2010-03-20 11:09
- ANVISA guidance bharat 2010-03-22 10:40
- ANVISA guidance Dr_Dan 2010-04-01 15:34
  - Bioanalysis of dropouts, etc. Helmut 2010-04-01 15:56

Correction to EMA Final BE-GL Helmut 2010-03-28 17:28
- Correction to EMA Final BE-GL yjlee168 2010-03-29 13:36
  - Correction to EMA Final BE-GL Helmut 2010-03-29 13:47
    - Correction to EMA Final BE-GL (for IR dosage forms) yjlee168 2010-03-29 13:55

Kel Determination Madhavi 2010-03-23 11:14
- Kel and R2 d_labes 2010-03-23 12:08

US FDA-Cmin in Bioequivalence criteria hitesh_chauhan 2010-03-19 12:46
- US FDA-Cmin in Bioequivalence criteria KR 2010-03-19 14:26

X-Ray film storage chirayu 2010-03-16 12:58
- X-Ray film storage Dr_Dan 2010-03-17 11:38