Bioequivalence and Bioavailability Forum

Three Formulation - Partial Replicate K2K 2013-10-18 10:05
- Three Formulation - Partial Replicate vinayshed 2013-10-28 08:42
  - Randomization? Helmut 2013-10-28 12:11
    - Randomization? vinayshed 2013-10-28 14:47
      - Randomization? Helmut 2013-10-28 15:09
        
        Randomization? K2K 2013-10-29 10:10
        
        not randomized! Helmut 2013-10-29 13:14
        
        not randomized! K2K 2013-10-31 10:08
        
        CVwr Helmut 2013-10-31 16:25

Widening Cmax in EU Clarc 2013-10-24 14:55
- Widening Cmax in EU drgunasakaran1 2013-10-24 15:43
- EMA: ABEL Helmut 2013-10-25 14:56
  - EMA: ABEL Clarc 2013-10-28 10:04

Fully Replicated design sirajudeen 2013-09-24 07:00
- Fully Replicated design Dr_Dan 2013-09-24 11:17
  - Fully Replicated design Yvonne 2013-10-14 09:39
    - RR values only Helmut 2013-10-14 17:28
      - RR values only d_labes 2013-10-14 18:38
        
        RR values only Helmut 2013-10-14 19:21
        
        RR values only Yvonne 2013-10-23 15:20
        
        RR values only Helmut 2013-10-23 17:51
        
        RR values only Yvonne 2013-10-24 09:01

Clarification on model statement in EMEA submission RK 2013-10-08 13:39
- EMA: all effects fixed Helmut 2013-10-08 14:08
  - EMA: all effects fixed RK 2013-10-09 06:32
    - EMA: all effects fixed - Method A! d_labes 2013-10-09 08:30
    - EMA: Method C “incompatible with CHMP GL” Helmut 2013-10-09 14:50
      - EMA: Method C “incompatible with CHMP GL” RK 2013-10-10 06:01

Partial replicate designs The Outlaw Torn 2013-09-25 08:21
- Partial replicate designs Helmut 2013-09-25 09:12
  - Partial replicate designs The Outlaw Torn 2013-09-25 11:10
    - Partial replicate designs Helmut 2013-09-25 16:35
      - Partial replicate designs The Outlaw Torn 2013-09-26 08:34
        
        OT Helmut 2013-09-26 08:56

fully replicate design with six sequences RK 2013-09-14 12:17
- Objective? Helmut 2013-09-15 13:47
  - Objective? jag009 2013-09-16 17:24
  - Objective? RK 2013-09-17 13:35
    - Objective? (again) Helmut 2013-09-17 13:51
      - Question: jag009 2013-09-17 15:49
        
        Imbalanced/incomplete sequences Helmut 2013-09-18 17:32
      - fully replicate design with four sequence RK 2013-09-20 13:56
        
        Period effects and sequences unrelated d_labes 2013-09-23 08:44
        
        Period effects and sequences unrelated RK 2013-09-24 13:16

Intersubject CV from Proc mixed (partial replicate study) jag009 2013-08-28 20:13
- Intersubject CV from Proc mixed d_labes 2013-08-29 14:54
  - Intersubject CV from Proc mixed jag009 2013-08-29 15:09
    - G matrix and OT d_labes 2013-08-30 09:56
      - G matrix and OT jag009 2013-09-04 17:29

3-per, 2-trt designs and estimation of intra-subj. variance ElMaestro 2013-08-12 19:54
- 3-per, 2-trt designs and estimation of intra-subj. variance Dr_Dan 2013-08-13 10:11
  - 3-per, 2-trt designs and estimation of intra-subj. variance ElMaestro 2013-08-13 15:00
    - TRT|RTR rulez! Helmut 2013-08-13 18:23
      - TRT|RTR rulez? Really? d_labes 2013-08-14 08:16
        
        TRT|RTR rulez? Really? Yes. ElMaestro 2013-08-14 11:29
        
        TRT|RTR rulez? Really? No. d_labes 2013-08-14 13:34
        
        TRT|RTR rulez? Really? No. ElMaestro 2013-08-14 14:25
        
        TRT|RTR Lost in formulas. d_labes 2013-08-14 16:35
        
        TRT|RTR rulez? References Helmut 2013-08-14 13:44
        
        References László & László d_labes 2013-08-14 19:12
        
        Heteroscedasticity Helmut 2013-08-17 17:33
        
        Heteroscedasticity: TRT|RTR rulez! d_labes 2013-08-29 16:45
        
        Heteroscedasticity: TRT|RTR rulez! ElMaestro 2013-08-29 17:50
        
        Sims & evaluation d_labes 2013-08-30 09:16
        
        Sims & evaluation ElMaestro 2013-08-31 14:11
        
        Evaluation subtleties d_labes 2013-08-31 17:20

RSAB model overspecified Wolfgang 2013-08-05 14:37
- RSAB model overspecified jag009 2013-08-05 15:35
- Proc Mixed FA0(1) for partial replicate d_labes 2013-08-05 15:59
  - Proc Mixed FA0(1) for partial replicate Wolfgang 2013-08-05 16:24
    - Proc Mixed FA0(1) for partial replicate ElMaestro 2013-08-05 17:19
      - Proc Mixed FA0(1) for partial replicate Wolfgang 2013-08-06 08:35
        
        Proc Mixed FA0(1) for partial replicate ElMaestro 2013-08-06 10:34
    - Proc Mixed FA0(1) for partial replicate d_labes 2013-08-06 10:30
      - FA0(1) for partial replicate in Phoenix Helmut 2013-08-07 15:13
        
        FA0(1) for partial replicate in SAS d_labes 2013-08-08 09:42
        FA0(1) for partial replicate in Phoenix lhughes 2013-08-30 15:17
        
        FA0(1) in PHX: works (& more questions) Helmut 2013-08-30 17:07

Partial Replicate vs Full Replicate study design jag009 2013-08-23 16:46
- Partial Replicate vs Full Replicate study design ElMaestro 2013-08-24 17:35
- Partial Replicate vs Full Replicate study design Dr_Dan 2013-08-26 09:16
  - Partial Replicate vs Full Replicate study design jag009 2013-08-26 15:42

RASBE - 95% upper confidence bound jag009 2013-06-05 22:48
- RASBE - 95% upper confidence bound Helmut 2013-06-06 09:13

CI calculation in full replicate design Ken Peh 2013-06-03 19:11
- CI calculation in full replicate design jag009 2013-06-03 20:06
  - CI calculation in full replicate design Ken Peh 2013-06-05 12:43
    - CI not needed in RSABE Helmut 2013-06-05 13:40
      - CI not needed in RSABE Ken Peh 2013-06-05 17:31
    - CI calculation in full replicate design jag009 2013-06-05 19:56

Clarification on HVD paper jag009 2013-05-13 16:56

Reporting RSABE to the FDA Helmut 2013-05-03 01:03
- Reporting RSABE to the FDA jag009 2013-05-03 16:37

FDA HVD SAS Code - Average BE using Proc Mixed jag009 2013-04-30 17:11
- Data set? Helmut 2013-04-30 17:44
  - Data set? jag009 2013-04-30 20:06

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