Bioequivalence and Bioavailability Forum

CVwithin calculation of biperiden CECIF 2018-01-17 20:44
- pooled CV from MR vs. IR Helmut 2018-01-18 16:46
  - pooled CV from MR vs. IR ElMaestro 2018-01-18 17:03
    - pooled CV from MR vs. IR jag009 2018-01-21 03:32
  - pooled CV from MR vs. IR Yura 2018-01-19 10:05
    - TSD: BE in stage 1 Helmut 2018-01-19 12:21
      - TSD: BE in stage 1 Yura 2018-01-19 13:21

Why is the bootstrap not widely used? ElMaestro 2018-01-13 11:06

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

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