Bioequivalence and Bioavailability Forum

Need some clarity on eCTD module 5 jag009 2024-07-12 16:04 [Regulatives / Guidelines]

Fed dissolution with 20% glucose yuva 2024-07-11 08:55 [Dissolution / BCS / IVIVC]

How to calculate %dissolved using USP Apparatus 4 (Open loop system)? rezkighassani 2024-07-11 07:50 [Dissolution / BCS / IVIVC]

Decrease in PSD: Need to repeat BE? qualityassurance 2024-07-02 08:32 [Study Assessment]
- Type-II Variation Helmut 2024-07-02 09:37
  - Type-II Variation: Waive in-vivo study by providing in-vitro data? qualityassurance 2024-07-02 11:29
    - Type-II Variation: Waive in-vivo study by providing in-vitro data? SMA 2024-07-02 16:27
      - Type-II Variation: Waive in-vivo study by providing in-vitro data? Relaxation 2024-07-04 12:19

Standard deviation of different designs BEQool 2024-06-27 12:25 [General Statistics]
- Standard deviation of different designs Helmut 2024-06-27 13:29
  - Standard deviation of different designs BEQool 2024-06-28 07:35
- Standard deviation of different designs ElMaestro 2024-06-29 22:08
  - Standard deviation of different designs BEQool 2024-07-01 07:25
    - Standard deviation of different designs ElMaestro 2024-07-01 07:38
      - Standard deviation of different designs BEQool 2024-07-01 08:41
        
        Standard deviation of different designs mittyri 2024-07-01 11:18
  - Standard deviation of different designs ElMaestro 2024-07-03 13:37

Consult animal trial design libaiyi 2024-07-03 11:52 [Design Issues]

Consult trial design libaiyi 2024-07-03 09:12 [Design Issues]

FDC: BA/BE study enough? qualityassurance 2024-07-03 05:21 [Regulatives / Guidelines]
- FDC: DDI study generally sufficient Helmut 2024-07-03 08:05

back conversion test Thair Saleh 2024-07-01 09:42 [Regulatives / Guidelines]

BE between one injection vs multiple injection products weiguo2122 2024-06-26 20:17 [Design Issues]
- BE between one injection vs multiple injection products weiguo2122 2024-06-27 15:07

average bioequivalence Mahmoud 2024-06-24 11:29 [Regulatives / Guidelines]
- Partial replicate design: ABE Helmut 2024-06-27 08:00

Case Report Form (CRF) as source data Mais 2024-06-24 07:04 [GxP / QC / QA]
- Case Report Form (CRF) as source data Ohlbe 2024-06-24 10:54
  - Case Report Form (CRF) as source data Mais 2024-06-25 06:06
    - Case Report Form (CRF) as source data Ohlbe 2024-06-25 17:42
      - Case Report Form (CRF) as source data Mais 2024-06-26 06:23

simulating dissolution data beyond observed lab data Achievwin 2024-06-07 15:42 [Dissolution / BCS / IVIVC]
- simulating dissolution data beyond observed lab data Helmut 2024-06-07 16:30
  - simulating dissolution data beyond observed lab data Rayhope 2024-06-26 00:50
- simulating dissolution data beyond observed lab data dshah 2024-06-10 09:10

Another one? Helmut 2023-07-19 09:04 [GxP / QC / QA]
- Confirmed Ohlbe 2023-07-21 12:59
  - Who cares? Helmut 2023-07-21 14:24
    - Who cares? Ohlbe 2023-07-21 14:39
      - Expert Helmut 2023-07-21 14:41
  - Questions about data manipulation mittyri 2023-07-22 19:57
    - Data manipulation Ohlbe 2023-07-22 20:47
    - Questions about data manipulation wienui 2023-07-23 17:29
      - Questions about data manipulation qualityassurance 2024-04-30 11:38
        
        Questions about data manipulation Helmut 2024-04-30 11:46
        
        Questions about data manipulation qualityassurance 2024-04-30 13:55
        
        Questions about data manipulation Helmut 2024-04-30 14:52
        
        Assessment report published Ohlbe 2024-06-05 12:45
        
        Questions about data manipulation Ohlbe 2024-04-30 18:25
        
        Questions about data manipulation ElMaestro 2024-05-01 07:10
        
        OT Helmut 2024-05-01 20:42
        Questions about data manipulation Ohlbe 2024-05-01 20:58
  - Update Helmut 2024-03-22 20:29
    - Health Canada recalls Helmut 2024-06-09 09:16
    - And the FDA… Helmut 2024-06-19 11:22
- Another one? Ajay Gupta 2023-07-24 04:19

Therapeutic equivalence kishorpatil 2011-02-08 10:24 [Design Issues]
- Therapeutic equivalence? d_labes 2011-02-08 10:37
  - Therapeutic equivalence? Dr_Dan 2011-02-08 14:40
    - Therapeutic equivalence? d_labes 2011-02-08 14:45
    - Therapeutic equivalence? bjkim97 2011-02-23 11:06
      - Therapeutic equivalence? Dr_Dan 2011-02-28 14:53
        
        Therapeutic equivalence? bjkim97 2011-03-03 12:37
  - Therapeutic equivalence? Mauricio Sampaio 2024-06-17 02:21
- Therapeutic equivalence raghu 2011-02-09 10:07

Admin contact
23,428 posts in 4,929 threads, 1,697 registered users;
87 visitors (0 registered, 87 guests [including 34 identified bots]).
Forum time: 08:22 CEST (Europe/Vienna)

If I’d observed all the rules,
I’d never have got anywhere. Marilyn Monroe

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz