Bioequivalence and Bioavailability Forum

WHO Letter of Concern Ohlbe 2022-11-28 09:56

Open Position at WHO Helmut 2022-11-03 14:19

Another two... Ohlbe 2021-09-16 23:41
- Another two... ElMaestro 2021-09-17 08:42
  - Dates Ohlbe 2021-09-17 10:15
  - Some more info Ohlbe 2021-09-17 20:28
    - EU Article 31 referral started Ohlbe 2022-01-24 17:47
- Cheating Helmut 2021-09-17 16:50
  - Increased variability Ohlbe 2021-09-17 17:56
    - Increased variability ElMaestro 2021-09-17 18:51
      - Visualization Helmut 2021-09-18 15:26
- Another two... jag009 2021-09-19 09:18
- Another two... ElMaestro 2022-05-24 12:00
  - Blind monitors or greedy sponsors? Helmut 2022-05-24 12:51
    - Blind monitors or greedy sponsors? Ohlbe 2022-05-24 14:21
      - Blind monitors or greedy sponsors? Helmut 2022-05-24 16:35
    - Blind monitors or greedy sponsors? ElMaestro 2022-05-25 08:11
      - (Cumulative) T/R-ratio vs. time Helmut 2022-05-25 09:19
        
        Sponsors and CRO selection Ohlbe 2022-05-25 10:53
        
        I still think that T/R-ratios are useful Helmut 2022-05-25 12:04
        
        T/R-ratios are useful Ohlbe 2022-05-25 14:40
        
        T/R-ratios are useful Helmut 2022-05-25 15:35
        Bust the Buster Helmut 2022-05-26 15:32
        
        complicate the assessor's life mittyri 2022-05-26 18:28
        
        complicate the assessor's life PharmCat 2022-05-27 09:57
        complicate the assessor's life Helmut 2022-05-27 10:11
        
        Thanks for Busting the Buster sameep 2022-05-31 08:34
        
        Thanks for Busting the Buster Helmut 2022-05-31 15:22
        
        A small point for the code sameep 2022-06-01 13:17
        
        A small point for the code Helmut 2022-06-01 14:11

ICH GCP type of the data Beholder 2021-04-05 11:56
- ICH GCP type of the data ElMaestro 2021-04-05 21:35

Auditor NDA/CDA ElMaestro 2021-03-09 18:22
- Auditor NDA/CDA jag009 2021-03-12 06:52
  - Auditor NDA/CDA ElMaestro 2021-03-12 07:32
    - Auditor NDA/CDA Helmut 2021-03-12 10:48
- Auditor NDA/CDA dshah 2021-03-16 06:29

New Art. 31 referral: suspected data manipulation again Ohlbe 2020-02-28 14:23
- New Art. 31 referral: suspected data manipulation again nobody 2020-02-28 16:40
- Referral concluded Ohlbe 2020-07-24 15:12
  - 💯 Helmut 2020-07-24 18:00

BE Study- Remote Monitoring - EMEA study biopk 2020-06-22 07:03
- EMA: Clinical Trials during COVID-19 pandemic Helmut 2020-06-22 10:57
  - EMA: Clinical Trials during COVID-19 pandemic biopk 2020-06-23 08:15

Reference ranges, prediction intervals ElMaestro 2020-06-20 22:41
- Reference ranges, prediction intervals Helmut 2020-06-21 13:28
- Reference ranges, prediction intervals Ohlbe 2020-06-22 15:38

Stability of IPs Loky do 2020-06-10 13:31
- Stability of IPs ElMaestro 2020-06-10 18:17
  - Stability of IPs Loky do 2020-06-16 13:24

Reporting of QA kishan_123 2019-11-06 15:27
- Reporting of QA PharmCat 2019-11-07 17:18
  - Reporting of QA kishan_123 2019-11-11 05:01
- Reporting of QA ElMaestro 2019-11-11 09:14

Randomization access akash 2019-08-16 07:43
- Randomization access Ohlbe 2019-08-16 13:28

Impartial Witness in BABE study yatish gosai 2019-05-22 07:49
- Impartial Witness in BABE study Ohlbe 2019-05-22 10:48
  - Impartial Witness in BABE study yatish gosai 2019-05-22 11:04
  - New Drugs and Clinical Trials Rules: Wrong definition of BE Helmut 2019-05-24 12:20
- Husband ≠ impartial Helmut 2019-05-22 10:52
  - Husband ≠ impartial yatish gosai 2019-05-22 11:04
    - Husband ≠ impartial nobody 2019-05-22 15:56
- Impartial Witness in BABE study ElMaestro 2019-05-22 16:11

Sample Shipment (dry ice) ☣ Helmut 2019-04-10 15:03
- Sample Shipment (dry ice) ☣ jag009 2019-04-12 07:32
  - Sample Shipment (dry ice) ☣ Helmut 2019-04-12 10:08
    - Satisfaction? mittyri 2019-04-12 15:14
      - Satisfaction? Helmut 2019-04-12 18:59

Training of SOPs Pandu 2019-03-25 11:16
- Training of SOPs WhiteCoatWriter 2019-03-25 13:13
  - Training of SOPs Pandu 2019-03-27 07:51
- Training of SOPs ElMaestro 2019-03-27 08:14

GLP or GCP for bioanalysis? ElMaestro 2019-01-20 11:42
- GLP or GCP for bioanalysis? nobody 2019-01-20 13:47
  - GLP or GCP for bioanalysis? ElMaestro 2019-01-20 13:54
    - Both, Cap't'n ! Ohlbe 2019-01-20 23:11
      - Both, Cap't'n ! ElMaestro 2019-01-21 09:42
        
        Both, Cap't'n ! nobody 2019-01-21 10:25
        Both, Cap't'n ! Ohlbe 2019-01-21 11:05
        
        Both, Cap't'n ! ElMaestro 2019-01-21 11:28
        
        Both, Cap't'n ! Ohlbe 2019-01-21 11:51
      - A great idea ElMaestro 2019-01-22 22:39
        
        Statements of GCP and GLP compliance Ohlbe 2019-01-23 00:29