Bioequivalence and Bioavailability Forum

Data analysis and sample size for replicate study designs as per recent FDA guidance balakotu 2023-05-23 12:16

regulatory guideline wock 2023-05-22 06:06

Design for the EMA ryraman2661 2023-05-15 13:03
- BE for the EMA Helmut 2023-05-15 13:40
  - BE for the EMA ryraman2661 2023-05-16 08:04
  - BE for the EMA Ohlbe 2023-05-16 08:51

Gender Effect on Clarithromycin Neera 2023-05-15 09:24

505 b(2) application & requirement of bioequivalence Mithu 2023-05-04 04:59
- 505 b(2) application & requirement of bioequivalence dshah 2023-05-05 13:38
  - 505 b(2) application & requirement of bioequivalence Mithu 2023-05-11 07:58
- 505 b(2) application & requirement of bioequivalence Achievwin 2023-05-05 16:08
  - 505 b(2) application & requirement of bioequivalence Mithu 2023-05-11 07:58

Chile regulatory Pharma_88 2023-05-10 04:19

ABE results from SAS and WinNolin are not matched weiguo2122 2023-04-19 14:43
- ABE results from SAS and WinNolin are not matched BEQool 2023-04-20 06:21
- Variable names, lexical order? Helmut 2023-04-20 08:13
  - Variable names, lexical order? PharmCat 2023-04-20 19:58
  - Variable names, lexical order? weiguo2122 2023-04-21 14:15
    - Variable names, lexical order? Helmut 2023-04-21 15:45

Chili guidelines gsrao2022 2022-12-25 16:17
- ANAMED Helmut 2022-12-27 09:42
  - ANAMED Pharma_88 2023-04-19 04:57

Oxcarbazepine Tablet Fasting and Fed AB661 2023-04-15 07:47

where can I find Old FDA PSG Achievwin 2023-03-24 14:51
- where can I find Old FDA PSG Ohlbe 2023-03-25 17:03
  - where can I find Old FDA PSG Achievwin 2023-03-27 02:10

UK/EU IMP Labelling requirement for Comparator used in BE studies HallaGulla 2023-03-22 12:34
- UK/EU IMP Labelling requirement for Comparator used in BE studies Ohlbe 2023-03-24 13:59

In vitro binding study for sevelamer carbonate for Europe submission jansari 2023-02-21 17:28
- In vitro binding study for sevelamer carbonate for Europe submission dshah 2023-02-22 16:40
  - In vitro binding study for sevelamer carbonate for Europe submission jansari 2023-02-23 16:22
    - In vitro binding study for sevelamer carbonate for Europe submission dshah 2023-02-23 17:18
      - In vitro binding study for sevelamer carbonate for Europe submission jansari 2023-02-24 15:24
        
        In vitro binding study for sevelamer carbonate for Europe submission dshah 2023-02-28 17:15
        
        In vitro binding study for sevelamer carbonate for Europe submission jansari 2023-03-01 15:34

Biowaiver for site transfer in Mexico jag009 2023-01-17 14:57
- Biowaiver for site transfer in Mexico Ricardo 2023-02-08 01:59

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

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

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