Bioequivalence and Bioavailability Forum

Bioequivalence Across 3 Different Injection Site XH7081 2022-09-21 20:22
- Bioequivalence Across 3 Different Injection Site dshah 2022-09-21 22:08
  - Bioequivalence Across 3 Different Injection Site XH7081 2022-09-22 17:14
- Two at a Time Helmut 2022-09-22 09:30
  - Two at a Time XH7081 2022-09-22 17:13
    - Two at a Time Helmut 2022-09-23 11:03

N calculation for trial about PK superiority alejandro_jo1990 2022-09-01 14:40
- Bracketing approach Helmut 2022-09-01 15:02
  - SmPC change is the whole thing alejandro_jo1990 2022-09-01 16:18
- N calculation for trial about PK superiority dshah 2022-09-02 11:52
  - The efocus is faster absorption alejandro_jo1990 2022-09-02 18:57
    - The efocus is faster absorption Helmut 2022-09-03 00:46
      - Non-parametric N alejandro_jo1990 2022-09-06 00:26
        
        Non-parametric N Helmut 2022-09-06 17:02
        
        Non-parametric N alejandro_jo1990 2022-09-15 14:56

Choosing formula for sample size Imph 2021-10-20 11:03
- Exact (Owen’s Q) Helmut 2021-10-20 11:36
  - Exact (Owen’s Q) Imph 2021-10-20 12:53
    - Exact (Owen’s Q) Helmut 2021-10-20 13:26
      - Exact (Owen’s Q) Imph 2021-10-24 10:41
        
        n iteratively from power Helmut 2021-10-24 10:54
        aproximate n d_labes 2021-10-24 19:26
      - Exact (Owen’s Q) Willem Talloen 2022-09-01 15:48
        
        PowerTOST & FDA Helmut 2022-09-01 16:31

Sample size for 3-way crossover chrisk 2022-08-09 18:55
- Sample size for 3-way crossover Helmut 2022-08-10 11:30
  - Sample size for 3-way crossover chrisk 2022-08-10 15:24
    - AND or OR, that’s the question Helmut 2022-08-10 15:58
      - AND or OR, that’s the question chrisk 2022-08-10 17:46
        
        AND or OR, that’s the question Helmut 2022-08-10 20:59
        
        AND or OR, that’s the question chrisk 2022-08-10 22:00
        
        AND or OR, that’s the question Helmut 2022-08-11 15:25
        
        AND or OR, that’s the question chrisk 2022-08-12 16:02
        
        The unknown ρ Helmut 2022-08-17 15:04

3 treatments with two-at-a-time approach chrisk 2022-08-01 07:03
- 3 treatments with two-at-a-time approach Helmut 2022-08-01 13:41
  - 3 treatments with two-at-a-time approach chrisk 2022-08-01 17:56

BCS Class II & IV molecule Mithu 2022-07-25 06:39
- BCS Class II & IV molecule dshah 2022-07-25 09:44
  - BCS Class II & IV molecule Mithu 2022-07-25 10:56
- in vivo ≠ in vitro Helmut 2022-07-25 09:56
  - in vivo ≠ in vitro Mithu 2022-07-25 10:54
    - in vivo ≠ in vitro dshah 2022-07-25 11:19
      - in vivo ≠ in vitro Mithu 2022-07-25 13:26
    - Assumptions Helmut 2022-07-25 13:02
      - Assumptions Mithu 2022-07-25 13:24

Sample size for the pilot study by the PASS2021 software dennis001 2022-07-24 10:56
- Pilot study (independent from software) Helmut 2022-07-24 12:27
  - Pilot study (independent from software) dennis001 2022-07-24 14:27
    - Rules of Thumb (PASS) Helmut 2022-07-24 14:55
      - Rules of Thumb (PASS) dennis001 2022-07-24 17:48

Probability to pass multiple studies Helmut 2021-02-19 12:02
- Probability to pass multiple studies ElMaestro 2021-02-19 12:57
  - Power limbo Helmut 2021-02-19 13:37
  - Probability to pass multiple studies ? Helmut 2022-06-24 14:03

Estimation of sample size for NIT using ISCV By R pharm07 2022-05-03 11:23
- Estimation of sample size for NTI using ISCV By R dshah 2022-05-03 13:04
- PowerTOST Helmut 2022-05-03 14:38
  - PowerTOST pharm07 2022-05-04 08:08
    - PowerTOST Helmut 2022-05-04 10:33
      - PowerTOST pharm07 2022-05-04 14:54
        
        PowerTOST pharm07 2022-05-11 05:30
        
        PowerTOST: sampleN.NTID() Helmut 2022-05-11 13:19
        
        PowerTOST: sampleN.NTID() pharm07 2022-05-18 05:18
        
        sampleN.NTID(): Example Helmut 2022-05-18 14:30
        
        sampleN.NTID(): Example pharm07 2022-05-19 05:36

Target Power for BE Studies Sereng 2022-05-12 17:45
- Target Power for BE Studies ElMaestro 2022-05-12 22:23
  - Target Power for BE Studies Sereng 2022-05-18 05:19
    - The guy in the penguin costume Helmut 2022-05-18 14:06

Back Calculating Sample Size Sereng 2022-05-12 17:40
- Back Calculating Sample Size ElMaestro 2022-05-12 22:29
  - Back Calculating Sample Size Helmut 2022-05-12 23:10
    - Back Calculating Sample Size ElMaestro 2022-05-13 01:38
    - Back Calculating Sample Size Sereng 2022-05-18 05:32
      - PowerTOST: Total sample size Helmut 2022-05-18 08:55
  - Back Calculating Sample Size dshah 2022-05-13 11:54
    - Algebra Helmut 2022-05-16 15:01
      - Algebra d_labes 2022-05-16 18:58
- Parallel designs: Don’t use the (conventional) t-test! Helmut 2022-05-17 14:17

Sample Size Estimate in BE Studies Sereng 2022-05-12 17:22
- Sample Size Estimate in BE Studies ElMaestro 2022-05-13 02:02
  - Sample Size Estimate in BE Studies Sereng 2022-05-18 05:58

Sample size and Replicated studies Bebac user 2022-03-23 09:38
- Sample size and Replicated studies dshah 2022-03-23 11:30
  - Output of sampleN.scABEL() Helmut 2022-03-23 12:43
    - Output of sampleN.scABEL() - expanded limits ? d_labes 2022-03-23 16:33
      - Output of sampleN.scABEL() - expanded limits ? Helmut 2022-03-23 16:45
    - Output of sampleN.scABEL() dshah 2022-03-23 18:08
      - Don’t use FARTSSIE for SABE Helmut 2022-03-23 19:42
- Sample size larger than clinical capacity Helmut 2022-03-23 11:43
- Sample size and Replicated studies Brus 2022-03-23 14:25

Sample Size "Efficiency" of Replicate CO vs. 2-way CO for NTID Sereng 2022-01-30 23:11
- Sample Size "Efficiency" of Replicate CO vs. 2-way CO for NTID ElMaestro 2022-01-30 23:50
  - OT d_labes 2022-01-31 18:48
- Follow the guidance (if possible) Helmut 2022-01-30 23:52
  - Follow the guidance (if possible) Sereng 2022-01-31 21:58
    - Now I got it! Helmut 2022-01-31 23:53

Sample size in fartssie Bebac user 2022-01-21 19:43
- No reference-scaling in FARTSSIE Helmut 2022-01-21 21:14
- Sample size in fartssie dshah 2022-01-24 10:57

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