Bioequivalence and Bioavailability Forum

IMP retention quantity requirement for Japan market Rahul Metangale 2023-01-23 11:31

M10 Q&A dated Jan 16 2023 ElMaestro 2023-01-20 09:32

Biowaiver for site transfer in Mexico jag009 2023-01-17 14:57

FDA's HVD SAS Code / Standard Error / CV j_kevin 2022-12-08 09:41
- FDA's HVD SAS Code / Standard Error / CV Helmut 2022-12-08 12:09
  - FDA's HVD SAS Code / Standard Error / CV j_kevin 2022-12-09 07:28
    - CV limbo Helmut 2022-12-09 13:36
      - CV limbo ElMaestro 2022-12-09 15:49
      - CV limbo j_kevin 2022-12-14 13:12
      - CV limbo j_kevin 2023-01-02 03:06
      - CV limbo j_kevin 2023-01-02 05:07
        
        CV limbo Helmut 2023-01-04 11:39

Chili guidelines gsrao2022 2022-12-25 16:17
- ANAMED Helmut 2022-12-27 09:42

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

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