Bioequivalence and Bioavailability Forum

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 in the Forum - HS, 2007-09-14 13:18
- Redesign of FDA's website :-( - HS, 2009-06-08 15:24

Scaled BE - Cmax, 2010-08-27 20:10 (Sample Size)
- Scaled BE - HS, 2010-08-30 16:02
  - Scaled BE - Cmax, 2010-09-04 08:51
    - Scaled BE (power?) - HS, 2010-09-04 13:42

Draft Guidance on Sevelamer Carbonate - Ravi, 2010-08-10 09:22 (Regulatives / Guidelines)
- Draft Guidance on Sevelamer Carbonate - govardhanpillari, 2010-09-04 09:08

Types of Designs - mvgchakravarthi, 2010-09-02 18:50 (Design Issues)
- Types of Designs - HS, 2010-09-02 19:02
  - Types of Designs - mvgchakravarthi, 2010-09-03 17:38

Cross-over 3x6 WNL x SAS - Maura, 2010-09-02 17:09 (Software)
- WNL partial F vs. SAS type III F - d_labes, 2010-09-03 08:58
  - WNL partial F vs. SAS type III F - HS, 2010-09-03 11:13
    - WNL almost the same as SAS - d_labes, 2010-09-03 12:10
      - WNL almost the same as SAS - Maura, 2010-09-03 14:07

ambulatory sample - thirupathireddy alla, 2010-09-02 06:36 (Regulatives / Guidelines)
- Sampling time deviations - Ohlbe, 2010-09-02 10:25
- ambulatory sample - HS, 2010-09-02 12:46
  - ambulatory sample - thirupathireddy alla, 2010-09-03 13:33

Time limit for withdrawal of ambulatory sample - thirupathireddy alla, 2010-08-31 08:36 (Regulatives / Guidelines)
- Deviations in sample withdrawal - HS, 2010-08-31 13:19
  - Deviations in sample withdrawal - thirupathireddy alla, 2010-09-01 08:12

Abrent Value - auditor, 2010-08-30 12:22 (Bioanalytics)
- Abrent? - Jaime_R, 2010-08-30 13:01
- Abrent Value - keshav khude, 2010-08-31 07:36

AUCreftmax - neethu, 2010-08-27 08:59 (Metrics)
- US, Canada only - HS, 2010-08-27 13:32
  - Canadian variation - d_labes, 2010-08-27 14:06
    - Canadian variation - HS, 2010-08-27 14:19
      - Canadian variation - neethu, 2010-08-30 06:09

Denmark: 100% included in Confidence Interval - HS, 2006-05-26 14:46 (Regulatives / Guidelines)
- Denmark: 100% included in Confidence Interval - Dr Andrew Leary, 2010-08-26 16:56
  - NTIDs - HS, 2010-08-26 17:48
    - NTIDs - Dr Andrew Leary, 2010-08-29 09:15

Non Linearity - Cmax, 2010-08-13 18:12 (Metrics)
- Non Linearity - ElMaestro, 2010-08-13 18:31
  - Non Linearity (SD vs. MD) - HS, 2010-08-13 19:11
    - Non Linearity (SD vs. MD) - Cmax, 2010-08-27 20:04
      - BE # dose proportionality - HS, 2010-08-28 14:29

Ref vs. Ref - kishor, 2010-08-19 08:41 (Study Performance)
- Ref vs. Ref - janmacek, 2010-08-27 09:20
- Ref vs. Ref - Cmax, 2010-08-27 19:50

T-license - kishor, 2010-08-17 13:17 (Regulatives / Guidelines)
- T-license - HS, 2010-08-17 14:12
  - Indian attitudes... - HS, 2010-08-26 12:52
    - Indian attitudes... - Cmax, 2010-08-27 19:46

Packaging of study products - janmacek, 2010-08-27 09:35 (Study Performance)
- Packaging of study products - Ohlbe, 2010-08-27 10:22
  - Packaging of study products - Dr_Dan, 2010-08-27 11:58
    - Packaging of study products - janmacek, 2010-08-27 13:29
    - Packaging of study products - Ohlbe, 2010-08-27 14:27
- Packaging of study products - Pavidus, 2010-08-27 13:17
  - Packaging of study products - Ohlbe, 2010-08-27 14:18

Reference Listed Drugs - auditor, 2010-08-26 14:06 (Regulatives / Guidelines)
- RLD (pivotal = pilot) - HS, 2010-08-26 14:26
  - Reference Listed Drugs - auditor, 2010-08-27 06:32

capacitabine BE study- statistical analysis - chak, 2010-08-23 14:39 (Regulatives / Guidelines)
- capacitabine BE study- statistical analysis - chak, 2010-08-26 16:08
  - Patience... - HS, 2010-08-26 16:21

Timing of high-fat breakfast - Dr Andrew Leary, 2010-08-24 12:13 (Design Issues)
- It's breakfast time - d_labes, 2010-08-24 13:00
  - Yummz - ElMaestro, 2010-08-24 15:09
    - Yummz - Dr Andrew Leary, 2010-08-24 16:22
    - Reading matters - HS, 2010-08-24 16:34
  - It's breakfast time - Dr Andrew Leary, 2010-08-24 16:20
    - It's breakfast time - Pavidus, 2010-08-25 14:11
      - It's breakfast time - Dr Andrew Leary, 2010-08-25 14:52
        It's breakfast time - ElMaestro, 2010-08-25 15:14
        It's breakfast time - Ohlbe, 2010-08-25 16:07
        It's breakfast time - Dr Andrew Leary, 2010-08-25 16:15
      - It's breakfast time - Dr_Dan, 2010-08-25 15:33
        It's breakfast time - Dr_Dan, 2010-08-25 15:49
        It's breakfast time - HS, 2010-08-25 16:22
        It's breakfast time - Pavidus, 2010-08-26 10:02

Kindly advice: How to use Group Effect in WinNonlin - kunal, 2010-08-13 08:21 (Software)
- Group Effect in WinNonlin - HS, 2010-08-13 13:59
  - Group Effect in WinNonlin - kunal, 2010-08-16 08:27
  - Group Effect in WinNonlin - kram, 2010-08-25 14:20

What is para IV filing? - Bhavesh, 2010-08-21 09:03 (Regulatives / Guidelines)
- ANDA Paragraph IV filing - d_labes, 2010-08-23 08:38

least square mean calculation - bvoggu, 2010-08-18 07:49 (General Statistics)
- least square mean calculation - HS, 2010-08-18 14:15
  - least square mean calculation - bvoggu, 2010-08-19 09:24
    - SE: SAS / PHX-WNL / manual - HS, 2010-08-19 12:36
      - Standard error - d_labes, 2010-08-19 16:18
        Standard error - HS, 2010-08-19 16:33
        Standard error - bvoggu, 2010-08-20 10:51
        Not with EXCEL - d_labes, 2010-08-20 14:57
- least square mean calculation - ElMaestro, 2010-08-18 14:46
  - least square mean calculation - bvoggu, 2010-08-20 07:41
    - LSMeans - ElMaestro, 2010-08-20 09:34

Transdermal patches guidlines (BA/BE) - Jignesh_reddy, 2010-08-20 05:07 (Regulatives / Guidelines)
- Topicals - HS, 2010-08-20 13:00

comparative dissolution profile between various strengths - Falisa_Mustafa, 2010-08-09 04:34 (Dissolution / BCS/IVIVC)
- comparative dissolution profile between various strengths - Dr_Dan, 2010-08-09 09:42
  - comparative dissolution profile between various strengths - Falisa_Mustafa, 2010-08-20 10:31

Difference between Clast obs and Clast pred... - bvoggu, 2010-08-19 11:38 (Metrics)
- Difference between Clast obs and Clast pred... - HS, 2010-08-19 12:49

add on study - maverick, 2010-08-18 13:09 (Regulatives / Guidelines)

ambulatory deviations - naveen331, 2010-08-17 14:13 (Study Performance)
- ambulatory deviations - HS, 2010-08-17 14:32

Sequence effect - kishor, 2010-08-17 13:13 (General Statistics)
- Sequence effect... - HS, 2010-08-17 13:40

Log transformation - pravin17, 2010-08-16 12:46 (General Statistics)
- Log transformation - HS, 2010-08-16 13:04

Deviation in maintaining Fed breakfast - Pankaj, 2010-08-16 06:45 (Study Performance)

Simvastatin Cmax - dr suresh gidwani, 2010-08-10 12:24 (Study Performance)
- Simvastatin Cmax - Srinetram, 2010-08-11 14:05
  - Simvastatin = prodrug - HS, 2010-08-12 16:35
    - Simvastatin = prodrug - dr suresh gidwani, 2010-08-16 06:28

Dry Ice Effect - keshav khude, 2010-08-14 08:40 (Bioanalytics)
- Dry Ice Effect - Ohlbe, 2010-08-14 13:16
  - Dry Ice Effect - HS, 2010-08-14 13:24
- Additional FT? - HS, 2010-08-14 13:20

Reference formulation for DCGI (Indian market) - pravin17, 2010-08-05 07:14 (Regulatives / Guidelines)
- Reference formulation for DCGI (Indian market) - Cmax, 2010-08-13 18:17

Manual integration - sagark, 2010-07-29 02:26 (Bioanalytics)
- Manual integration - HS, 2010-07-29 15:30
  - Manual integration - ElMaestro, 2010-07-29 21:07
    - History - HS, 2010-07-30 01:30
  - LSB - evil, terrible and annoying - ElMaestro, 2010-07-30 23:46
- Bad integration: Example - HS, 2010-07-30 20:24
  - Bad integration: Example - sagark, 2010-07-31 12:57
    - Bad integration: Example - HS, 2010-08-01 02:09
      - Better integration? Example - HS, 2010-08-12 20:11
        Better integration? Example - ElMaestro, 2010-08-12 23:14
        Better algorithms / more awareness of analysts - HS, 2010-08-13 13:43
- Manual integration - keshav khude, 2010-08-13 09:11

Premethod validation of x drug - Jagdish Bairagi, 2010-07-27 16:34 (Bioanalytics)
- Gibberish - HS, 2010-07-27 16:45
- Premethod validation of x drug - keshav khude, 2010-08-13 10:08

batch reinjection when QC failed - vish14184, 2010-08-07 20:09 (Bioanalytics)
- batch reinjection when QC failed - Ohlbe, 2010-08-10 17:57
  - batch reinjection when QC failed - keshav khude, 2010-08-13 09:46

Donepezil SR 23 mg Tablets BE study - madhavaraob, 2010-07-07 07:27 (Study Performance)
- Donepezil SR 23 mg Tablets BE study - drgunasakaran1, 2010-07-17 07:23
  - Donepezil SR 23 mg Tablets BE study - madhavaraob, 2010-07-22 09:06
    - Donepezil SR 23 mg Tablets BE study - Pavidus, 2010-07-22 10:09
      - Donepezil SR 23 mg Tablets BE study - chaitanyag, 2010-07-23 05:18
  - Donepezil SR 23 mg Tablets BE study - chaitanyag, 2010-07-26 14:34
    - CROs - HS, 2010-07-26 15:01
    - Donepezil SR 23 mg Tablets BE study - Dr. Solanki, 2010-08-07 10:28
      - Donepezil SR 23 mg Tablets BE study - Dr. Solanki, 2010-08-12 11:30