Bioequivalence and Bioavailability Forum

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

BCS Based Biowaiver application Price? - joosefupas, 2018-10-19 14:54 [Dissolution / BCS / IVIVC]

Little thing which changes almost everything in EEU - Beholder, 2018-10-18 09:08 [Bioanalytics]
- LLOQ ≤5% of expected or observed Cmax? - Helmut, 2018-10-18 12:28
  - LLOQ ≤5% of average or minimal Cmax? - Beholder, 2018-10-18 13:59
    - LLOQ ≤5% of individual Cmax-values - Helmut, 2018-10-18 18:20
      - LLOQ ≤5% of individual Cmax-values - mittyri, 2018-10-18 19:50
        
        An outlier? - Beholder, 2018-10-19 09:43

Quality System - vishal1721, 2018-10-19 09:29 [GxP / QC / QA]

Virtual Bioequivalence: a myth or coming reality? - mittyri, 2018-06-09 22:39 [Dissolution / BCS / IVIVC]
- Virtual Bioequivalence: a myth or coming reality? - jag009, 2018-06-13 02:40
- Virtual Bioequivalence: a myth or coming reality? - elba.romero, 2018-10-19 01:17

Qualitative analysis of the ANOVA residuals - Lucas, 2014-02-19 14:27 [General Statistics]
- Qualitative analysis of the ANOVA residuals - Helmut, 2014-02-19 15:22
  - Qualitative analysis of the ANOVA residuals - Lucas, 2014-02-19 15:58
    - Qualitative analysis of the ANOVA residuals - Helmut, 2014-02-19 16:25
      - Qualitative analysis of the ANOVA residuals - Lucas, 2014-02-19 17:20
      - Qualitative analysis of the ANOVA residuals - Lucas, 2014-02-20 19:07
        
        First hints for Phoenix - Helmut, 2014-02-20 20:11
        Phoenix: residuals - Helmut, 2014-02-21 19:25
        
        Phoenix: residuals - BRN, 2014-03-04 15:15
        
        Phoenix: residuals - Helmut, 2014-03-04 16:52
        
        Phoenix: residuals - Rosy, 2018-10-15 07:03
        
        Software validation - Helmut, 2018-10-15 11:43
        
        Software validation - Rosy, 2018-10-18 00:38
        
        Avoid raw residuals - Helmut, 2018-10-18 17:14
        
        Avoid raw residuals - Rosy, 2018-10-18 18:05
        
        Phoenix → R - Helmut, 2014-02-23 02:20
        
        Phoenix → R - Lucas, 2014-02-25 19:28
- Qualitative analysis of the ANOVA residuals - ElMaestro, 2014-02-19 15:32
  - Qualitative analysis of the ANOVA residuals - Helmut, 2014-02-19 16:06
  - Qualitative analysis of the ANOVA residuals - Lucas, 2014-02-19 16:13
    - Qualitative analysis of the ANOVA residuals - ElMaestro, 2014-02-19 20:40

BioBridges slides? - ElMaestro, 2017-09-29 10:41 [Conferences / Workshops]
- BioBridges slides? - Helmut, 2017-09-29 11:58
  - BioBridges slides? - luvblooms, 2017-09-29 13:54
  - BioBridges slides? - ElMaestro, 2017-09-29 14:40
- BioBridges slides - Helmut, 2018-01-08 12:08
  - BioBridges slides 2018 - Beholder, 2018-10-18 10:15
    - BioBridges slides 2018 - Helmut, 2018-10-18 11:21

FDA: Size of bio-batch - Helmut, 2013-12-10 14:05 [Regulatives / Guidelines]
- FDA: Size of bio-batch - jag009, 2013-12-10 20:03
  - FDA: antique of ’93 - Helmut, 2013-12-10 23:32
    - FDA: antique of ’93 - jag009, 2013-12-11 15:23
      - FDA: antique of ’93 - Helmut, 2013-12-11 15:26
        
        FDA: antique of ’93 - jag009, 2013-12-11 16:21
        
        FDA: antique of ’93 - Helmut, 2013-12-11 16:29
        
        FDA: antique of ’93 - jag009, 2013-12-11 23:16
        
        Patience - Helmut, 2013-12-12 14:34
    - FDA: antique of ’93 - Beholder, 2018-06-21 09:21
      - Nice numbers - Helmut, 2018-06-21 15:05
        
        Nice numbers - Beholder, 2018-06-22 10:33
        
        Type II variation - Helmut, 2018-06-22 15:12
      - Birdsong's third law of BE - ElMaestro, 2018-06-22 10:10
        
        Experience - Beholder, 2018-06-22 11:04
        
        Why, oh why? - Helmut, 2018-06-22 15:17
        
        Sorry for the delay - Beholder, 2018-10-18 09:40

Theophylline ER 450 mg study design - Ramesh Ramalingam, 2018-10-18 07:16 [Design Issues]

Reference drug product for Captopril / Hydrochlorothiazide - A-M-R, 2018-10-17 14:46 [Design Issues]

Product-specific advice (steroid nasal sprays) - Mikalai, 2018-10-16 13:42 [Design Issues]
- Product-specific advice (steroid nasal sprays) - ElMaestro, 2018-10-16 20:35
  - Product-specific advice (steroid nasal sprays) - Mikalai, 2018-10-17 09:40
    - Product-specific advice (steroid nasal sprays) - ElMaestro, 2018-10-17 11:56

Power is getting high - kms.srinivas, 2017-12-26 07:39 [Power / Sample Size]
- Power is getting high? - d_labes, 2017-12-26 12:08
- Stop estimating post hoc power! - Helmut, 2017-12-26 12:22
  - Stop estimating post hoc power! - kms.srinivas, 2017-12-26 13:00
    - Stop estimating post hoc power! - ElMaestro, 2017-12-26 14:11
    - Simulations - Helmut, 2017-12-26 15:51
      - Simulations - BE-proff, 2017-12-27 06:53
        
        Simulations - ElMaestro, 2017-12-27 07:25
        Simulations - Yura, 2017-12-27 08:23
        
        Simulations - kms.srinivas, 2017-12-27 09:11
        
        Simulations - Yura, 2017-12-27 10:07
        
        α and 1–β - Helmut, 2017-12-27 12:57
        
        α and 1–β - Yura, 2017-12-27 13:33
        
        α and 1–β - Helmut, 2017-12-27 14:31
        
        α and 1–β - Yura, 2017-12-28 06:50
        
        Educate the IEC and regulators - Helmut, 2017-12-28 11:30
        
        “Forced BE” 101 - Helmut, 2017-12-27 12:23
        
        “Forced BE” 101 - kms.srinivas, 2017-12-27 12:41
        
        Would you be so kind answering our questions? - Helmut, 2017-12-27 13:02
        
        Would you be so kind answering our questions? - kms.srinivas, 2017-12-28 05:53
        
        Yes, but why? - Helmut, 2017-12-28 11:47
        
        Yes, but why? - DavidManteigas, 2017-12-28 16:59
        
        Optimists and pessimists - Helmut, 2017-12-28 17:33
        
        "normal" GMR setting - d_labes, 2017-12-28 18:57
        
        Example for discussion - mittyri, 2017-12-28 22:06
        
        Example for discussion - Helmut, 2017-12-28 22:33
        
        I prefer to play it safe - Helmut, 2017-12-28 22:10
        
        Full ACK - d_labes, 2017-12-28 17:41
        About GMR 1.10 - kms.srinivas, 2017-12-29 13:20
        
        Better 0.95 or 0.90 - Helmut, 2017-12-29 16:18
        
        Yes, but why? - Yura, 2017-12-29 13:46
        Buffon's needle - Astea, 2018-01-20 23:55
        
        Buffon's needle - Oleg777, 2018-10-09 22:48
        
        0.95 or 1.05 - Helmut, 2018-10-10 13:41
        
        Buffon's needle - Helmut, 2018-10-10 12:46
        
        Buffon's needle - Astea, 2018-10-11 23:14
        
        School maths - Helmut, 2018-10-12 01:10
        
        School russian - Astea, 2018-10-12 12:41
        Offtop: Umschrift der westlichen Eigennamen auf Russisch - mittyri, 2018-10-12 23:25
        
        EEU? - mittyri, 2017-12-28 21:52
        
        EEU? - Yura, 2017-12-29 13:41
        
        EEU - pharmacokinetic equation??? - mittyri, 2017-12-29 14:11
        
        EEU? - Beholder, 2018-01-16 15:10
        
        Simulations - xtianbadillo, 2018-01-18 22:22
- Numbers don't lie - ElMaestro, 2017-12-28 20:13

Enoxaparin sodium injection BA BE studies - varsha chungde, 2018-10-08 11:34 [Regulatives / Guidelines]
- BE of parenterals - Helmut, 2018-10-08 11:53
- Enoxaparin sodium injection BA BE studies - nobody, 2018-10-09 10:42
  - Enoxaparin sodium injection BA BE studies - varsha chungde, 2018-10-10 07:09
- Enoxaparin sodium injection BA BE studies - ElMaestro, 2018-10-09 11:13
  - Enoxaparin sodium injection BA BE studies - varsha chungde, 2018-10-10 07:11

How to prepare QC for endogenous molecule - chandru, 2018-09-10 17:33 [Bioanalytics]
- How to prepare QC for endogenous molecule - chandru, 2018-10-10 03:20

All animals are equal, but some animals are more equal than others - Helmut, 2018-10-09 14:33 [BE/BA News]

Redesign of the EMA’s website - Helmut, 2018-10-08 12:20 [BE/BA News]

Bioequivalence and Bioavailability Forum 10:37 CEST