Bioequivalence and Bioavailability Forum

HVD Pilot: 3 candidates, 1 reference Shah 2021-07-16 13:40
- HVD Pilot: 3 candidates, 1 reference ElMaestro 2021-07-16 13:51
  - HVD Pilot: 3 candidates, 1 reference lukamar 2021-07-20 08:54
    - HVD Pilot: 3 candidates, 1 reference ElMaestro 2021-07-20 09:31

Intrauterine Device – Levonorgestrel 52 mg marianna.macera 2021-06-30 15:04
- Intrauterine Device – Levonorgestrel 52 mg Relaxation 2021-06-30 17:22
  - Intrauterine Device – Levonorgestrel 52 mg marianna.macera 2021-07-02 16:55
    - Intrauterine Device – Levonorgestrel 52 mg Helmut 2021-07-02 17:18

Three-way crossover BABE Studies acfalcao 2007-09-16 22:34
- Three-way crossover example data set Helmut 2007-09-17 20:47
  - Three-way crossover example data set acfalcao 2007-09-17 23:02
    - Three-way crossover example data set Helmut 2007-09-18 12:47
      - Three-way crossover (WinNonlin) Nirali 2007-09-21 06:49
        
        Three-way crossover (WinNonlin) Helmut 2007-09-21 13:04
        
        Three-way crossover (WinNonlin) Nirali 2007-09-25 08:05
        
        Three-way crossover (WinNonlin) Helmut 2007-09-25 13:15
      - Three-way crossover example data set Irene_I 2018-06-07 11:09
        
        Three-way crossover example data set Helmut 2018-06-07 13:04
        
        Three-way crossover example data set Irene_I 2018-06-08 11:09
        Three-way crossover example data set Irene_I 2018-06-12 09:21
        
        Leave-One-Out (IBD) Helmut 2018-06-12 12:42
        
        Leave-One-Out (IBD) Irene_I 2018-06-13 05:02
        
        Impact of pooled variance (bias, CI) Helmut 2018-06-13 15:02
        
        carry (over?) d_labes 2018-06-13 15:31
  - Pseudo-periods ElAlumno 2019-03-14 23:40
    - Pseudo-periods Helmut 2019-03-15 00:47
      - Two‐at‐a‐Time analysis in R ElAlumno 2019-03-22 21:59
        
        fixed & mixed (dammit!) and a request to SASians Helmut 2019-03-23 01:03
        
        Pooled vs IBD T-R in SAS from non-SASian mittyri 2019-03-23 23:13
        
        Pooled vs IBD T-R in SAS from non-SASian Helmut 2019-03-23 23:36
        
        mixed in R mittyri 2019-03-23 23:50
        
        mixed in R (EMA B ≠ FDA) Helmut 2019-03-24 01:23
  - Williams design 3-way Brus 2021-06-09 16:48
    - Williams design 3-way Helmut 2021-06-09 17:48
      - Williams design 3-way Brus 2021-06-10 14:33
        
        Williams design 3-way Helmut 2021-06-10 15:03
        
        Williams design 3-way vezz 2021-06-10 17:23
        
        Williams design 3-way Helmut 2021-06-10 20:14
        
        Williams design 3-way vezz 2021-06-11 09:11
        
        Williams design 3-way Brus 2021-06-11 12:19
        Williams design 3-way Relaxation 2021-06-11 12:42
        
        Period effects in general Helmut 2021-06-11 15:41
        Williams design 3-way vezz 2021-06-11 16:56

Food effects prasad.v 2021-06-08 08:35
- Food effects drgunasakaran1 2021-06-09 06:06

partial AUCs for locally acting MR Susanh 2020-12-04 16:14
- partial AUCs for locally acting MR jag009 2020-12-05 08:01
  - partial AUCs for locally acting MR Kumarnaidu2 2021-05-28 11:55
    - partial AUCs for locally acting MR dshah 2021-05-31 08:47

bioequivalence if test and reference formulation having different strengths Vishal S 2021-05-24 09:21
- least common multiple of T and R Helmut 2021-05-24 12:32
  - least common multiple of T and R Vishal S 2021-05-25 13:26
    - least common multiple of T and R drgunasakaran1 2021-05-25 14:22
    - least common multiple of T and R Helmut 2021-05-26 00:23

Two-stage replicate design studies for RSABE Achievwin 2021-05-14 19:20
- Two-stage design ❌ RSABE Helmut 2021-05-14 20:14
  - Two-stage design ❌ RSABE Achievwin 2021-05-19 19:08
    - Two-stage design & RSABE: Forget it! Helmut 2021-05-19 20:40

Biowaiver for Emusion Dosage Form surajpatel 2021-05-11 10:27
- Biowaiver for Emusion Dosage Form drgunasakaran1 2021-05-12 07:52

Exclusion due to adverse event Loky do 2021-03-29 15:59
- State it in the SAP & observe it Helmut 2021-03-29 18:08
- Exclusion due to adverse event dshah 2021-03-31 14:43

BE study designing related doubts gsrao2022 2021-03-28 20:12
- BE study designing related doubts Helmut 2021-03-29 00:41

Question raised by the PMDA Helmut 2021-02-26 15:46
- Question raised by the PMDA Ben 2021-03-19 15:47
  - Question raised by the PMDA Helmut 2021-03-19 18:06

Obeticholic Acid Study Researcher101 2021-02-23 20:35

RLD strength for BE study Brus 2021-01-21 14:24
- 505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ Helmut 2021-01-21 14:37
  - 505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ Brus 2021-01-25 16:56
    - Directive 2001/83/EC, Article 10(3) = hybrid Helmut 2021-01-25 17:39

Glucose Clamp Algorithm VijithRoy 2020-12-04 06:35

Orlistat EMA Pharma_88 2020-11-27 13:51

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