Bioequivalence and Bioavailability Forum

Frequent Queries from FDA: Gender Imbalance krish85 2022-11-14 04:06
- Frequent Queries from FDA: Gender Imbalance dshah 2022-11-14 16:01
- Frequent Queries from FDA: Gender Imbalance ElMaestro 2022-11-14 21:46
- Frequent Queries from FDA: Gender Imbalance jag009 2022-11-22 07:02

US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-01 22:16
- 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

strange question: An RLD (RS) which can be scored jag009 2022-09-08 19:30
- 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
- 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

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

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

Biowaiver criteria - 5% Laura Carreiras 2022-08-12 12:03
- Biowaiver criterion <5% (not ≤5%) Helmut 2022-08-12 12:17
  - Biowaiver criterion <5% (not ≤5%) Laura Carreiras 2022-08-12 12:37
    - Biowaiver criterion <5% (not ≤5%) wienui 2022-08-16 18:22

Partial AUC Vaibhav Patil 2022-07-29 07:20
- H[a]VD and MDT Helmut 2022-07-29 11:04
  - Plateau Time in Kazakhstan? mittyri 2022-07-30 14:17
    - Plateau Time in Kazakhstan? Helmut 2022-08-01 18:44
      - EEU changes came into force 11.03.2021 mittyri 2022-08-01 21:24

no gender differences deepakpangavhane 2022-07-30 08:55
- doxylamine gender differences mittyri 2022-07-30 13:52
  - doxycycline gender differences deepakpangavhane 2022-07-30 14:03
    - doxycycline ≠ dicycloverine = dicyclomine ≠ doxylamine mittyri 2022-07-30 14:49
      - doxycycline ≠ dicycloverine = dicyclomine ≠ doxylamine deepakpangavhane 2022-08-01 10:44

BE NOC fee for Gliclazide 60 mg MR Tablet Tricky TAB 2022-07-03 08:21
- BE NOC fee for Gliclazide 60 mg MR Tablet kratos 2022-07-28 12:49

schedule time vs. actual time for ANVISA BE Shuanghe 2022-07-10 00:36
- schedule time for ANVISA? Helmut 2022-07-10 15:37
- schedule time vs. actual time for ANVISA BE Relaxation 2022-07-12 13:50
  - Not even wrong Helmut 2022-07-12 16:15
    - Not even wrong Shuanghe 2022-07-13 15:23
      - ANVISA: MD studies no more required Helmut 2022-07-13 17:03
  - Relatorio estatistico Ohlbe 2022-07-13 10:23
    - Relatorio estatistico Helmut 2022-07-13 11:02
      - ANVISA Ohlbe 2022-07-13 12:37
        
        ANVISA Helmut 2022-07-13 17:17
      - Relatorio estatistico pjs 2022-07-25 10:42
        
        Full book? Helmut 2022-07-25 12:32
  - schedule time vs. actual time for ANVISA BE Shuanghe 2022-07-13 15:21
- schedule time vs. actual time for ANVISA BE ElMaestro 2022-07-12 23:10
  - TPD? Helmut 2022-07-12 23:29
    - TPD? ElMaestro 2022-07-12 23:32
      - TPD! Helmut 2022-07-12 23:55
  - schedule time vs. actual time for ANVISA BE Shuanghe 2022-07-13 15:15
    - schedule time vs. actual time for ANVISA BE ElMaestro 2022-07-14 14:57

Drug-Drug Interaction procedure -between inhalation and oral Tab Mr.Rao 2022-07-15 08:47
- Relax & cool down? Helmut 2022-07-15 09:54

Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph wienui 2022-07-07 10:37
- Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph Ohlbe 2022-07-07 10:55
  - Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph dshah 2022-07-07 18:52
    - Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph wienui 2022-07-07 20:48
      - Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph dshah 2022-07-08 10:23
- Conflicts of interest (COI) ElMaestro 2022-07-08 13:18
  - Off topic Helmut 2022-07-08 16:29
    - Off topic ElMaestro 2022-07-08 16:54
      - Off topic Helmut 2022-07-08 20:41
        
        CRO belong to the pharmaceutical Company (CRO b2Ph wienui 2022-07-08 22:18
        
        CRO belong to the pharmaceutical Company (CRO b2Ph ElMaestro 2022-07-09 08:51
        
        CRO subsidiary of pharmaceutical company Helmut 2022-07-09 19:21

BMI Loky do 2022-06-26 17:05
- BMI in the protocol Helmut 2022-06-26 17:19
  - BMI in the protocol Loky do 2022-06-29 11:11
  - BMI in the protocol ElMaestro 2022-06-29 14:44

Unequal variances in parallel design Imph 2022-06-20 16:16
- Welch’s t-test Helmut 2022-06-20 16:47
  - Welch’s t-test Imph 2022-06-23 13:02
    - Welch’s t-test Helmut 2022-06-23 14:19
      - Welch’s t-test Imph 2022-06-26 10:06
        
        Read the paper, use the code(s)! Helmut 2022-06-26 12:12

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