Bioequivalence and Bioavailability Forum

▼ Read before registering ▼ - Helmut, 2016-04-14 23:39 [Tips / Tricks]

effectiveness of highly variable drugs - Ken Peh, 2013-12-17 03:45 [Off Topic]
- HVDs/HVDPs = safe drugs - Helmut, 2013-12-17 15:11
  - HVDs/HVDPs = safe drugs - varun9461, 2019-02-22 12:23
- effectiveness of highly variable drugs - Dr_Dan, 2013-12-18 09:34
  - effectiveness of highly variable drugs - Ohlbe, 2013-12-18 10:07
    - effectiveness of highly variable drugs - Ken Peh, 2013-12-20 14:38
      - Period effect - kumarnaidu, 2014-01-28 07:54
        
        Period effect - Dr_Dan, 2014-01-28 10:36
        
        Period effect - kumarnaidu, 2014-01-28 11:51
        
        Period effect - Helmut, 2014-01-28 13:48
        
        Period effect - kumarnaidu, 2014-01-29 04:49

bear v2.7.8 released (GUI) - yjlee168, 2017-04-13 21:58 [R for BE/BA]
- bear v2.7.8 released (GUI) - jag009, 2019-01-06 05:51
  - install GTK+ driver for bear - yjlee168, 2019-01-06 07:23
    - install GTK+ driver for bear - jag009, 2019-01-07 01:06
      - install GTK+ driver for bear - yjlee168, 2019-01-07 08:47
        
        strange misc.pk for replicate - Astea, 2019-02-17 19:05
        
        strange misc.pk for replicate - yjlee168, 2019-02-18 09:15
        bear v2.8.3-3 released - yjlee168, 2019-02-21 20:47

inter-batch variability? - Dr_Dan, 2010-08-04 10:29 [Regulatives / Guidelines]
- inter-batch variability? - Pavidus, 2010-08-04 11:57
- inter-batch variability? - d_labes, 2010-08-04 13:58
- inter-batch variability? - ElMaestro, 2010-08-04 17:09
  - Between study variability common for HVDs - Helmut, 2010-08-04 19:45
    - Between study variability common for HVDs - ElMaestro, 2010-08-04 21:01
      - Representative batches? - Helmut, 2010-08-04 23:42
        
        Representative batches? - ElMaestro, 2010-08-05 08:40
        
        Representative batches? - Helmut, 2010-08-05 12:30
        
        Representative batches? - Dr_Dan, 2010-08-05 08:58
        
        Representative batches? - Helmut, 2010-08-05 12:45
        
        Confidence intervals vs. point estimators - Dr_Dan, 2010-08-06 09:55
        
        Confidence intervals vs. point estimators - ElMaestro, 2010-08-06 12:34
        
        Confidence intervals vs. point estimates - Helmut, 2010-08-06 13:20
        Confidence intervals vs. point estimators - Dr_Dan, 2010-08-06 14:44
        
        Confidence intervals vs. point estimators - ElMaestro, 2010-08-06 15:01
        
        meta analysis? - martin, 2010-08-06 17:25
        
        meta analysis? - ElMaestro, 2010-08-06 17:57
        
        meta analysis? - Helmut, 2010-08-06 18:31
        
        meta analysis? - Ohlbe, 2010-08-06 23:21
        
        No chance against RMS? - Dr_Dan, 2010-08-10 12:27
        
        No chance against RMS? - ElMaestro, 2010-08-10 16:26
  - Batch-to-Batch Pharmacokinetic Variability - kumarnaidu, 2016-07-20 07:16
    - tlast (Common) - Helmut, 2016-07-20 10:48
      - tlast (Common) - nobody, 2019-02-21 15:20
        
        tlast (Common) - ElMaestro, 2019-02-21 16:32
        
        tlast (Common) - nobody, 2019-02-21 17:02
        
        tlast (Common) - ElMaestro, 2019-02-21 18:02
        
        tlast (Common) - nobody, 2019-02-21 18:17

CV values in BE studies: intra, or inter, or total? - Elena777, 2018-01-20 12:31 [Study Assessment]
- CV values in BE studies: intra, or inter, or total? - jag009, 2018-01-20 19:18
  - CV values in BE studies: intra, or inter, or total? - Elena777, 2018-01-20 21:10
    - CV values in BE studies: intra, or inter, or total? - jag009, 2018-01-21 03:17
      - CV values in BE studies: intra, or inter, or total? - Elena777, 2018-01-21 08:21
- CV values in BE studies: intra, or inter, or total? - Helmut, 2018-01-21 17:33
- CV values in BE studies: intra, or inter, or total? - ElMaestro, 2018-01-21 18:17
  - CV values in BE studies: intra, or inter, or total? - Elena777, 2018-01-27 09:57
    - CV values in BE studies: intra, or inter, or total? - Louis52, 2018-02-07 20:22
      - CV values in BE studies: intra, or inter, or total? - Helmut, 2018-02-07 20:31
        
        CV values in BE studies: intra, or inter, or total? - Rosy, 2019-02-19 18:33
        
        PowerTOST: CVfromCI - Helmut, 2019-02-20 13:00
        
        PowerTOST: CVfromCI -> CI.BE - d_labes, 2019-02-20 14:12
        
        Oops! - Helmut, 2019-02-20 15:32
        
        Oops! df? - d_labes, 2019-02-20 19:45
        
        Oops! df? - Helmut, 2019-02-20 20:43
        
        Oops! df! - d_labes, 2019-02-21 10:54
        Oops! df? - zizou, 2019-02-21 11:33
        
        Oops! df? - nobody, 2019-02-21 12:42
        All the answers are here - d_labes, 2019-02-21 14:49
        
        PowerTOST: CVfromCI - Rosy, 2019-02-20 15:25
        
        type known.designs() in PowerTOST - Helmut, 2019-02-20 16:14
        
        type known.designs() in PowerTOST - Rosy, 2019-02-20 17:14

Representation of BQL values in concentration data - GM, 2019-02-21 06:28 [Bioanalytics]
- Representation of BQL values in concentration data - ElMaestro, 2019-02-21 06:58
  - Representation of BQL values in concentration data - GM, 2019-02-21 08:06
    - Representation of BQL values in concentration data - ElMaestro, 2019-02-21 08:15

Health Canada Study reports - anky1212, 2019-02-21 05:05 [Regulatives / Guidelines]

AUC0-tau at steady state - BNR, 2016-03-31 22:46 [NCA / SHAM]
- AUC0-tau at steady state - jag009, 2016-03-31 23:05
  - AUC0-tau at steady state - BNR, 2016-03-31 23:43
    - RTFM - Helmut, 2016-04-01 00:59
      - RTFM - BNR, 2016-04-01 02:05
      - AUC0-τ estimation with time deviations - Astea, 2019-02-10 16:38
        
        AUC0-τ estimation with time deviations - Helmut, 2019-02-10 19:32
        
        Cτ for lin and lin-up/log-down - Astea, 2019-02-10 20:50
        
        Cτ by lin-/lin, lin-up/log-down, and λz - Helmut, 2019-02-11 01:45
        
        inter- vs extra- - Astea, 2019-02-11 19:46
        
        inter- vs extra- - Helmut, 2019-02-12 02:20
        No rule fits all - mittyri, 2019-02-14 12:55
        
        one size fits all vs goal posts - Astea, 2019-02-16 08:33
        
        one size fits all vs goal posts - ElMaestro, 2019-02-16 13:33
        
        Bias etc. - Helmut, 2019-02-16 14:26
        
        software: NCA not validated - Helmut, 2019-02-16 13:59
        
        no way out for NCA validation? - mittyri, 2019-02-20 21:22
        
        Default rules - mittyri, 2019-02-20 21:40

calibration curve range - Ladi, 2016-02-23 09:22 [Bioanalytics]
- calibration curve range - ritesh.korat.pharma, 2016-02-26 19:35
  - calibration curve range - Ladi, 2016-03-03 06:02
  - calibration curve range - Ohlbe, 2016-03-03 16:46
- calibration curve range - Ohlbe, 2016-03-03 16:41
  - calibration curve range - wienui, 2019-02-20 18:13
    - calibration curve range - Helmut, 2019-02-20 18:19
      - calibration curve range - wienui, 2019-02-20 18:32

Thalidomide - Rosy, 2019-02-19 23:09 [Study Assessment]

Trinidad and Tobago Bio-equivalence guidelines - varun9461, 2019-02-18 11:56 [Regulatives / Guidelines]

Dose curve - Sundar.M, 2019-02-15 13:37 [PK / PD]

Outlier Tests - GM, 2018-07-30 13:57 [Outliers]
- Outlier Tests - GM, 2019-02-14 07:24
- Outlier Tests - ElMaestro, 2019-02-14 09:27
  - Outlier Tests - GM, 2019-02-14 19:08
    - Outlier Tests - ElMaestro, 2019-02-14 22:11
      - Outlier Tests - GM, 2019-02-15 04:58

Dabigatran EMA - product-specific guide - nobody, 2019-02-13 18:58 [Regulatives / Guidelines]
- Dabigatran EMA - product-specific guide - ElMaestro, 2019-02-13 22:59
  - OT: A major loss - Helmut, 2019-02-14 00:24
    - OT: A major loss - nobody, 2019-02-14 09:31
      - OT: A major loss - Helmut, 2019-02-14 11:37
        
        OT: A major loss - nobody, 2019-02-14 13:40
- Dabigatran EMA - product-specific guide - Helmut, 2019-02-14 12:12
  - Dabigatran EMA - product-specific guide - nobody, 2019-02-14 13:34
    - Dabigatran EMA - product-specific guide - Helmut, 2019-02-14 13:52
      - Dabigatran EMA - product-specific guide - nobody, 2019-02-14 15:01

AUC <5% of TEST geometric mean AUC - vezz, 2019-02-13 08:35 [Outliers]
- AUC <5% of TEST geometric mean AUC - ElMaestro, 2019-02-13 09:36
  - AUC <5% of TEST geometric mean AUC - vezz, 2019-02-13 10:08
    - AUC <5% of TEST geometric mean AUC - ElMaestro, 2019-02-13 12:09

FDA: RSABE for NTID - Jay, 2018-03-26 13:31 [RSABE / ABEL]
- FDA: RSABE for NTID - jag009, 2018-03-26 17:57
  - FDA: RSABE for NTID - Jay, 2018-04-02 06:28
    - FDA: RSABE for NTID - pjs, 2018-04-02 15:07
      - FDA: RSABE for NTID - Jay, 2018-04-04 14:24
        
        β = 1 – π - Helmut, 2018-04-04 15:03
        
        Warfarin Sodium 95% Upper bound criteria - Nirali, 2019-01-30 15:38
        
        Upper bound in RSABE ≤0 - Helmut, 2019-02-02 14:15
        
        Upper bound in RSABE ≤0 - Nirali, 2019-02-12 07:10

Bioequivalence and Bioavailability Forum 06:25 CET