Bioequivalence and Bioavailability Forum

IntraCV calculation youivab 2017-12-27 06:20
- IntraCV calculation BE-proff 2017-12-27 06:49
  - IntraCV calculation youivab 2017-12-28 01:35
- IntraCV calculation kms.srinivas 2017-12-27 06:53
  - IntraCV calculation youivab 2017-12-28 01:37
    - IntraCV calculation GM 2017-12-28 06:56

T/R ratio for estimation of sample size in BE study of NTI drugs mahmoud-teaima 2017-10-24 19:18
- T/R ratio for estimation of sample size in BE study of NTI drugs Helmut 2017-10-24 23:15
  - T/R ratio for estimation of sample size in BE study of NTI drugs ElMaestro 2017-10-25 12:34
    - T/R ratio for estimation of sample size in BE study of NTI drugs nobody 2017-10-26 14:03
      - Defaults in PowerTOST d_labes 2017-10-26 14:49

T/R ratio and the content of the active compound in each product CECIF 2017-10-11 18:18
- assumed (!) T/R ratio Helmut 2017-10-11 19:18
  - assumed (!) T/R ratio CECIF 2017-10-11 20:35

Pivotal BE trial power not enough to 0.8 ssussu 2017-09-22 07:40
- Pivotal BE trial power not enough to 0.8 ElMaestro 2017-09-22 07:46
  - Pivotal BE trial power not enough to 0.8 ssussu 2017-09-22 09:21

Sample size for FDA's in vitro population BE ElMaestro 2017-09-08 17:24
- Extra-marital cohabitation Helmut 2017-09-08 18:05
  - The hidden details ElMaestro 2017-09-08 18:42
    - The hidden details Helmut 2017-09-09 12:29
- Sample size for FDA's in vitro population BE mahmoud-teaima 2017-09-10 16:12
  - Sample size for FDA's in vitro population BE ElMaestro 2017-09-10 16:23
    - Sample size for FDA's in vitro population BE mahmoud-teaima 2017-09-11 13:26

CVintra for Cmax > AUC, therefore use AUC for sample size? nobody 2017-08-07 17:14
- CVintra for Cmax > AUC, therefore use AUC for sample size? Helmut 2017-08-07 18:40
  - CVintra for Cmax > AUC, therefore use AUC for sample size? nobody 2017-08-07 19:52
    - Crap… Helmut 2017-08-07 20:29
      - Crap… nobody 2017-08-07 21:31
- CVintra for Cmax > AUC, therefore use AUC for sample size? ElMaestro 2017-08-07 23:04
  - CVintra for Cmax > AUC, therefore use AUC for sample size? nobody 2017-08-08 10:06
- CVintra for Cmax > AUC, therefore use AUC for sample size? jag009 2017-08-09 06:21
  - CVintra for Cmax > AUC, therefore use AUC for sample size? nobody 2017-08-09 17:11

How to create table of results BE-proff 2017-07-20 14:09
- How to create table of results ElMaestro 2017-07-20 14:32
  - How to create table of results BE-proff 2017-07-20 15:02
- How to create table of sample sizes / powers Helmut 2017-07-20 15:18
  - How to create table of sample sizes / powers BE-proff 2017-07-20 16:00
    - Symmetrical in log-scale Helmut 2017-07-20 17:12
      - Symmetrical in log-scale BE-proff 2017-07-24 11:42
        
        RTFM Helmut 2017-07-24 18:18

Estimation within-subject CV Mikkabel 2017-07-07 10:13
- Estimation within-subject CV ElMaestro 2017-07-07 10:17
- CVwR ~ CVwT ~ CVw? Helmut 2017-07-07 16:09
  - CVwR ~ CVwT ~ CVw? zizou 2017-07-08 15:29
    - CVwR = CVwT < CVw‽ Helmut 2017-07-08 16:45
      - 'whatif' plotting from 4X2 to 2X2 mittyri 2017-07-08 23:47
    - CVwR ~ CVwT ~ CVw? ElMaestro 2017-07-09 00:16
      - CVwR ~ CVwT ~ CVw? zizou 2017-07-09 02:13

Assumptions for powering a XO study Laura R 2017-06-01 14:57
- CVintra ≠ CVtotal Helmut 2017-06-01 15:47

Sample Size calculation and setting of BE limit base on Cmax or AUC mahmoud-teaima 2017-05-22 13:55
- PK metric with largest variability – generally – drives the sample size Helmut 2017-05-22 15:16
  - Regulatory guidance versus literature data mahmoud-teaima 2017-05-23 12:31
    - FDA: If RSABE not recommended in product-specific guidance Helmut 2017-05-23 13:15
      - FDA: If RSABE not recommended in product-specific guidance mahmoud-teaima 2017-05-23 16:20

Canada: Sample size for Cmax? Helmut 2012-12-18 18:04
- Canada: IUT violated? d_labes 2012-12-19 14:00
  - Canada: IUT violated? Helmut 2012-12-29 15:59
    - IUT d_labes 2012-12-31 13:36
- Canada: Sample size for Cmax: R-code? VStus 2017-01-19 10:10
  - Canada: Sample size for Cmax: R-code? zizou 2017-01-19 12:20
  - HC: Sample size for AUC and Cmax: exact and sim’s Helmut 2017-01-19 12:30
    - HC: Sample size for AUC and Cmax: exact and sim’s VStus 2017-01-31 13:44

Sample size justification rajasekhar 2017-01-20 09:54
- Post hoc sample size “justification” Helmut 2017-01-20 11:59

Expected Power Ben 2016-12-29 14:15

Sample Size II BE-proff 2016-12-28 08:14
- Please see the answer to your previous post mittyri 2016-12-28 09:17
  - Please see the answer to your previous post BE-proff 2016-12-28 10:35
    - Another Master's answer mittyri 2016-12-28 11:38
- Sample Size II ElMaestro 2016-12-28 10:52
- Expected power answer d_labes 2016-12-28 13:42
- Sample Size and regulators DavidManteigas 2016-12-28 18:11
  - Sample Size and sponsors d_labes 2016-12-28 19:24
    - Sample Size and spongulators ElMaestro 2016-12-28 22:22
  - Sample Size and regulators mittyri 2016-12-29 11:44
  - Sample Size and regulators Helmut 2016-12-29 12:39

Why do we need pooled CV? BE-proff 2016-08-24 08:48
- Maximum CV might be misleading Helmut 2016-08-24 12:07
  - Maximum CV might be misleading BE-proff 2016-08-26 10:41
    - Pooling – example Helmut 2016-08-26 11:34
      - Pooling – example BE-proff 2016-12-28 14:37
        
        in my protocols… Helmut 2016-12-29 12:27
- Why do we need pooled CV? ElMaestro 2016-08-24 13:03
  - Yessir! Common sense! Helmut 2016-08-24 13:53
    - Common sense weighting before pooling mittyri 2016-08-24 15:13
  - Gut feeling is the answer! DavidManteigas 2016-08-25 11:09
    - The reasons not to pool Astea 2016-08-26 20:40
      - The reasons not to pool mittyri 2016-08-28 22:05
      - Know your drug/formulation! Helmut 2016-08-29 11:56

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