Bioequivalence and Bioavailability Forum

2012 events listing - HS, 2011-10-10 03:15 [Conferences / Workshops]
- 3rd World Congress on BABE-2012, 26-28 March, Hyderabad - Dr_Dan, 2011-10-11 12:03
  - 2nd World Congress - ElMaestro, 2011-10-13 14:40
    - Going Off-Topic ♠♣♥♦ - HS, 2011-10-14 02:37
- Cross-over Trials by Stephen Senn - HS, 2012-01-16 17:22

Guidance Documents - HS, 2006-01-20 23:28 [Regulatives / Guidelines]
- ...other Sources - HS, 2007-02-20 16:16
- Requests for Update - HS, 2007-08-14 20:30
- Questions for regulatory requirements… - HS, 2007-09-14 13:18
- Redesign of FDA's website :-( - HS, 2009-06-08 15:24

anova in BE - AB, 2012-02-05 15:21 [General Statistics]

BMI vs LIC for age and weight chart - Vardhan82, 2012-02-03 06:26 [Regulatives / Guidelines]
- Between subject differences in Xovers - HS, 2012-02-04 11:30

Dissolution of Effervescent Tablets - joyjac, 2012-01-26 03:48 [Study Performance]
- Dissolution of Effervescent Tablets - JMCardot, 2012-02-04 10:58

Bioequivalence criteria for endogenous drug - pash413, 2012-02-03 12:15 [Regulatives / Guidelines]
- Bioequivalence criteria for endogenous drug - drgunasakaran1, 2012-02-04 05:31

DCGI BE-NOC - rave04, 2012-02-03 06:10 [Regulatives / Guidelines]
- DCGI BE-NOC - drgunasakaran1, 2012-02-03 06:45
  - DCGI BE-NOC - rave04, 2012-02-03 07:23
    - DCGI BE-NOC - drgunasakaran1, 2012-02-03 13:19
- DCGI BE-NOC - Vardhan82, 2012-02-03 06:57
  - DCGI BE-NOC - rave04, 2012-02-03 07:31

Change in ULOQ concentration - auditor, 2012-02-03 08:28 [Bioanalytics]

Biosimilars - M.Vasu, 2011-11-24 14:01 [Design Issues]
- Biosimilars - HS, 2011-11-24 14:44
  - Biosimilars - M.Vasu, 2011-11-28 12:33
    - Healthy subjects vs. patients - HS, 2011-11-28 12:56
  - Biosimilars - Ben, 2011-12-16 19:04
- Biosimilars - Chiku, 2012-02-03 06:43

Statistical Out come - auditor, 2012-02-01 12:58 [General Statistics]
- Statistical Out come - ElMaestro, 2012-02-02 12:05
- Statistical Out come - Ohlbe, 2012-02-02 19:13

Estimation on Kel, AUCi, Thalf - MGR, 2012-02-02 05:48 [PK Metrics]

BE of Effervescent Tablets - joyjac, 2012-01-12 09:45 [Study Performance]
- BE of Effervescent Tablets - MGR, 2012-01-12 12:14
  - Check absorption! - HS, 2012-01-13 17:11
  - BE of Effervescent Tablets - shyam_5p, 2012-01-31 06:55
    - BE of Effervescent Tablets - Ohlbe, 2012-01-31 17:55
      - BE of Effervescent Tablets - shyam_5p, 2012-02-01 04:01
    - BE of Effervescent Tablets - drgunasakaran1, 2012-01-31 18:01

clinical trials/ BE studies for locally acting drugs - jagankm, 2012-01-25 11:26 [Regulatives / Guidelines]
- clinical trials/ BE studies for locally acting drugs - drgunasakaran1, 2012-01-31 18:42
  - clinical trials/ BE studies for locally acting drugs - Ohlbe, 2012-01-31 19:01

unknown linearity - kudra23, 2012-01-30 10:30 [Regulatives / Guidelines]
- linear PK required for biowaiver - HS, 2012-01-31 02:45
  - ... or knowledge of non-linearity - Ohlbe, 2012-01-31 17:47
    - ... or knowledge of non-linearity - kudra23, 2012-01-31 18:18

acceptance criteria of calibration standards - haydonat, 2012-01-30 14:27 [Bioanalytics]
- acceptance criteria of calibration standards - Ohlbe, 2012-01-30 18:11
  - acceptance criteria of calibration standards - haydonat, 2012-01-31 15:02
    - acceptance criteria of calibration standards - Ohlbe, 2012-01-31 18:05

Sample Size Replicated Study - ashwinim13, 2008-08-18 10:42 [Power / Sample Size]
- Sample Size Replicated Study - HS, 2008-08-18 11:57
  - Sample Size Replicated Study - d_labes, 2008-08-21 09:13
    - Sample Size Replicated Study - HS, 2008-08-21 12:25
- Sample Size Replicated Study - vidulabhole, 2012-01-31 08:11
  - 4-treatment-4-period study - d_labes, 2012-01-31 10:35
    - 4-treatment-4-period study - vidulabhole, 2012-01-31 13:15
      - Clinical study - d_labes, 2012-01-31 16:38

SAS and missing values - HS, 2012-01-06 01:47 [Software]
- SAS and missing values - Shuanghe, 2012-01-13 11:17
  - THX & another request - HS, 2012-01-13 13:31
    - Congratulations for both of us :-D - Shuanghe, 2012-01-13 16:14
      - FDA's RSABE: Phoenix ‘validated’ against SAS - HS, 2012-01-13 16:39
        
        How to obtain CINV value in Phoenix - Shuanghe, 2012-01-19 11:43
        
        Import from external source - HS, 2012-01-19 14:24
        
        Thanks, it's done!! - Shuanghe, 2012-01-19 22:42
        
        Thanks, it's done!! - HS, 2012-01-20 00:10
- SAS and missing values - JMCardot, 2012-01-31 03:12

Strength selection - Paresh, 2012-01-27 06:47 [Design Issues]
- Strength selection - HS, 2012-01-27 16:07
  - Strength selection - Paresh, 2012-01-28 11:29
    - Strength selection - HS, 2012-01-28 14:27
      - Strength selection - Ohlbe, 2012-01-28 18:20
        
        Swiss reference? - HS, 2012-01-28 18:30
        
        Swiss reference? - Ohlbe, 2012-01-28 22:31
        
        EU reference! - HS, 2012-01-29 03:51

EMA - Exclusion of data - d_labes, 2012-01-24 11:09 [Regulatives / Guidelines]
- EMA - Exclusion of data - HS, 2012-01-24 15:53
- EMA - Exclusion of data - ElMaestro, 2012-01-24 16:47
  - LSMeans? - d_labes, 2012-01-26 08:34
    - LSMeans? - ElMaestro, 2012-01-26 13:22

Paper on RSABE/ABEL - HS, 2012-01-04 15:46 [Power / Sample Size]
- Paper on RSABE/ABEL - earlybird, 2012-01-10 14:11
  - Paper on RSABE/ABEL - Ben, 2012-01-12 19:22
    - Hyslop/Howe - HS, 2012-01-25 13:26
      - Hyslop/Howe - Ben, 2012-01-25 17:51
  - FARTSSIE on RSABE/ABEL - d_labes, 2012-01-25 11:12
    - FARTSSIE on RSABE/ABEL - earlybird, 2012-01-26 10:44
- PowerTOST vs. simulation on ABEL - d_labes, 2012-01-25 15:29

Subject to include in BE protocol (FDA SABE approach) - Shuanghe, 2012-01-26 09:44 [Regulatives / Guidelines]

SD’s Cτ predictive of MD BE? - HS, 2012-01-24 16:45 [PK Metrics]

Sample Size Calculation for partial and full replicate study - balakotu, 2012-01-24 09:44 [Regulatives / Guidelines]
- The power to know - no - d_labes, 2012-01-24 10:49
  - The power to know - no - balakotu, 2012-01-24 11:17
    - Sample size tables used - d_labes, 2012-01-24 12:13
    - Not that easy at all - HS, 2012-01-24 13:26

Calibration Curve - auditor, 2012-01-20 11:15 [Bioanalytics]
- Duplicate LLOQ and ULOQ - Ohlbe, 2012-01-20 11:59
  - Duplicate LLOQ and ULOQ - HS, 2012-01-20 13:09
    - Duplicate LLOQ and ULOQ - Ohlbe, 2012-01-20 14:26
      - Duplicate LLOQ and ULOQ - HS, 2012-01-20 18:02
        
        Calibration Curve - auditor, 2012-01-21 05:45
        
        Calibration Curve - HS, 2012-01-21 12:35
        
        Calibration Curve - Ohlbe, 2012-01-21 13:44
        
        Calibration Curve - HS, 2012-01-22 21:48

Expedited Review from IEC in case of change in study design - amatewadi, 2012-01-09 12:46 [Regulatives / Guidelines]
- Expedited Review from IEC in case of change in study design - Ohlbe, 2012-01-09 15:54
  - Expedited Review from IEC in case of change in study design - amatewadi, 2012-01-11 05:31
    - New trial = new opinion - Ohlbe, 2012-01-11 10:40
- Sample size: parallel ≠ 2× cross-over! - HS, 2012-01-09 16:22
- Expedited Review from IEC in case of change in study design - drgunasakaran1, 2012-01-13 17:51
  - Expedited Review from IEC in case of change in study design - amatewadi, 2012-01-22 14:26

study sample analysis - Falisa_Mustafa, 2012-01-20 04:06 [Bioanalytics]
- study sample analysis - HS, 2012-01-20 13:22

Tmax in Partial Replicate Design - Joshua, 2012-01-17 06:59 [Nonparametrics]
- Good question! - HS, 2012-01-17 11:34
  - Good question! - Joshua, 2012-01-20 11:54
    - Early exposure (+scaling?) - HS, 2012-01-20 12:56
- Tmax in Partial replicate design - d_labes, 2012-01-20 11:12
  - Tmax in Partial replicate design - Joshua, 2012-01-20 12:09
    - Intra-subject contrast (difference) - d_labes, 2012-01-20 12:55
      - Intra-subject contrast (difference) - Joshua, 2012-01-20 13:01

Design the generic ophthalmic solutions clinical trials - gore.lalit, 2012-01-20 05:26 [Design Issues]
- Design the generic ophthalmic solutions clinical trials - ElMaestro, 2012-01-20 08:31

FDA enforcing QbD from 2013 - ElMaestro, 2012-01-19 15:19 [Dissolution / BCS/IVIVC]
- FDA enforcing QbD from 2013 - HS, 2012-01-19 15:48

Spiking in plasma more then 5% - auditor, 2012-01-19 08:47 [Bioanalytics]
- Spiking in plasma more then 5% - Ohlbe, 2012-01-19 11:19

Biowaiver of strengh in fixed combinatios - Averroes, 2012-01-18 13:05 [Regulatives / Guidelines]

WHO BTIF - K2K, 2012-01-12 05:15 [Regulatives / Guidelines]
- WHO BTIF - HS, 2012-01-12 13:55
  - WHO BTIF - K2K, 2012-01-13 05:51
    - WHO BTIF - HS, 2012-01-13 17:05
      - WHO BTIF - Ohlbe, 2012-01-13 18:41
        
        WHO BTIF - HS, 2012-01-13 18:54
        
        WHO BTIF - K2K, 2012-01-16 12:51
        
        Inter- or intra-subject CV? - HS, 2012-01-16 13:26
        
        intrasubject - K2K, 2012-01-16 13:35
        
        intrasubject - HS, 2012-01-16 14:50
        
        intrasubject - K2K, 2012-01-18 09:36

manual power calculation - Karthik, 2011-03-17 10:17 [Power / Sample Size]
- manual power calculation: why? - HS, 2011-03-28 14:40
  - manual power calculation: why? - K2K, 2012-01-16 12:56
    - FARTSSIE.xls - HS, 2012-01-16 13:14
      - FARTSSIE.xls - K2K, 2012-01-16 13:21
        
        CV from CI: manual, PowerTOST, FARTSIE.xls - HS, 2012-01-16 14:27
        
        CV from CI: manual, PowerTOST, FARTSIE.xls - K2K, 2012-01-18 09:35

Biowaiver Monographs - HS, 2006-06-02 17:57 [Dissolution / BCS/IVIVC]
- Biowaiver Monographs (Update) - HS, 2007-02-04 00:35
  - Biowaiver Monographs (Update) - Charmainey, 2010-07-22 06:31
    - Biowaiver Monographs (new FIP link) - HS, 2010-07-23 19:52
- Biowaiver Monographs (Update) - HS, 2007-05-28 14:30
- Biowaiver Monographs (Update) - HS, 2008-05-21 23:24
- Biowaiver Monographs (Update) - HS, 2008-09-23 00:33
- Biowaiver Monographs (Update) - HS, 2009-02-07 15:24
- Biowaiver Monographs (Update) - HS, 2009-05-20 19:58
  - Dodium and the end of world - d_labes, 2009-12-17 08:37
- Biowaiver Monographs (Update) - HS, 2009-12-17 00:14
- Biowaiver Monographs (Update) - HS, 2011-03-05 12:50
- Biowaiver Monographs (Update) - HS, 2011-09-20 13:33
- Biowaiver Monographs (Update) - HS, 2012-01-17 17:50

Power for unbalanced cross-over - d_labes, 2011-01-14 15:21 [Power / Sample Size]
- Great post! - HS, 2011-01-14 16:16
  - Santa is coming - d_labes, 2011-12-22 09:30
    - PowerTOST - Ben, 2012-01-02 17:39
      - BIBDs - HS, 2012-01-02 17:53
        
        Uuups - d_labes, 2012-01-17 11:49
      - PowerTOST robust - d_labes, 2012-01-17 11:53