Bioequivalence and Bioavailability Forum

Open Position at WHO Helmut 2022-11-03 14:19 [GxP / QC / QA]

Bioequivalence Across 3 Different Injection Site XH7081 2022-09-21 20:22 [Power / Sample Size]
- 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

US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-01 22:16 [Regulatives / Guidelines]
- US (or EU) ANDA: Fail f2 but pass BE? wienui 2022-09-01 23:22
  - US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-02 00:29
    - US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-02 11:37
      - US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-04 23:13
        
        US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-05 11:16
        
        US (or EU) ANDA: Fail f2 but pass BE? wienui 2022-09-05 23:29
        
        US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-06 00:49
        
        US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-08 19:32
        
        US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-09 17:56
        US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-15 11:09
        
        US (or EU) ANDA: Fail f2 but pass BE? Rayhope 2022-09-15 15:13
        
        US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-20 16:02

replicateBE_xlsx datafile roman_max 2020-06-10 17:32 [🇷 for BE/BA]
- replicateBE: data input Helmut 2020-06-10 18:14
  - replicateBE: data input roman_max 2020-06-22 17:06
  - replicateBE: error in data input thalita_m 2022-09-17 05:28
    - replicateBE: Data import Helmut 2022-09-17 11:02

IVIVC calculations mahendra 2013-10-24 16:10 [Dissolution / BCS / IVIVC]
- IVIVC calculations yjlee168 2013-10-24 19:22
  - IVIVC calculations mahendra 2013-10-24 19:45
    - IVIVC calculations yjlee168 2013-10-24 22:21
      - Mergers Helmut 2013-10-25 14:38
      - IVIVC calculations mahendra 2013-10-25 16:49
        
        PCDCON ⇒ IVIVC calculations yjlee168 2013-10-27 05:41
      - IVIVC calculations thalita_m 2019-06-18 02:51
- IVIVC calculations jag009 2013-10-24 23:17
  - Minitab etc. Helmut 2013-10-25 14:43
    - Minitab etc. jag009 2013-10-25 16:27
      - XL Helmut 2013-10-25 16:38
        
        XL jag009 2013-10-28 20:42
        
        XL luvblooms 2013-10-29 05:08
        
        XL jag009 2013-10-29 15:07
        
        XL luvblooms 2013-10-30 07:00
        
        Broken link Helmut 2013-10-30 14:40
        XL jag009 2013-10-30 16:35
        
        XL luvblooms 2013-10-31 08:15
        
        XL jag009 2013-10-31 20:31
        Any news? jag009 2013-11-06 16:44
        
        Good News luvblooms 2013-11-07 10:50
        
        PBPK IVIVC jag009 2013-11-27 16:44
        
        PBPK IVIVC luvblooms 2013-11-27 19:31
        
        PBPK IVIVC jag009 2013-11-27 20:04
        
        Good News jag009 2013-11-28 06:01
        
        Contact Helmut 2013-11-07 14:50
        
        Contact jag009 2013-11-27 16:42
        
        XL thalita_m 2019-06-18 02:46
        
        Jean-Michel Helmut 2019-06-18 11:08
        
        Jean-Michel thalita_m 2019-06-20 22:18
        
        Jean-Michel Abel1972 2020-06-17 05:28
        
        Jean-Michel thalita_m 2022-09-17 05:50
    - Minitab etc. Achievwin 2020-06-17 15:00
  - IVIVC calculations mahendra 2013-10-25 16:48
- IVIVC calculations vinayshed 2013-10-28 08:54

ANVISA RDC Nº 742 Helmut 2022-09-12 10:27 [BE/BA News]
- ANVISA RDC Nº 749 dshah 2022-09-16 19:13

Initial dose and design issues abridged submission daily ER vs BID IR alejandro_jo1990 2022-09-15 15:35 [Design Issues]

N calculation for trial about PK superiority alejandro_jo1990 2022-09-01 14:40 [Power / Sample Size]
- 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

strange question: An RLD (RS) which can be scored jag009 2022-09-08 19:30 [Regulatives / Guidelines]
- strange question: An RLD (RS) which can be scored dshah 2022-09-09 17:52
- strange question: An RLD (RS) which can be scored wienui 2022-09-14 17:25

T/R potency <5% Achievwin 2022-09-07 18:22 [Regulatives / Guidelines]
- T/R potency <5% Helmut 2022-09-07 18:55
  - T/R potency <5% Achievwin 2022-09-07 20:50
    - T/R potency <5% jag009 2022-09-08 19:54
    - T/R potency <5% dshah 2022-09-09 10:48
      - T/R potency <5% Helmut 2022-09-09 12:13
      - T/R potency <5% Achievwin 2022-09-09 14:56
        
        T/R potency <5% Helmut 2022-09-09 17:08
        T/R potency <5% dshah 2022-09-09 17:42

NCA PK Bebac user 2022-09-01 13:38 [🇷 for BE/BA]
- NCA PK Helmut 2022-09-01 14:34
  - NCA PK Bebac user 2022-09-04 15:15
    - bear on 🇷 ≥4.2 Helmut 2022-09-04 15:33

Application of 90% CI for Ctau Mithu 2022-09-01 06:55 [Regulatives / Guidelines]
- Do your homework first Helmut 2022-09-01 16:40

Choosing formula for sample size Imph 2021-10-20 11:03 [Power / Sample Size]
- 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

system and system2 in R ElMaestro 2022-08-29 22:29 [Software]
- system and system2 in R Helmut 2022-08-30 01:10
  - system and system2 in R ElMaestro 2022-08-30 08:52
    - system and system2 in R Helmut 2022-08-30 11:25
  - processx package mittyri 2022-08-31 17:50
- tryCatch in R mittyri 2022-08-31 17:53
  - tryCatch in R ElMaestro 2022-09-01 10:33
    - tryCatch in R mittyri 2022-09-01 14:07

Why was TRT (treatment) included in Random effect of PROC Mixed? neilfiona 2022-09-01 11:58 [Regulatives / Guidelines]