Bioequivalence and Bioavailability Forum

Bioequivalence study in Multiple countries Achievwin 2025-02-21 02:02
- Bioequivalence study in Multiple countries Achievwin 2025-03-07 19:02

open-label BE trials maintain blindness kimhuang 2023-10-14 09:19
- Blinded NCA Helmut 2023-10-14 10:40
  - Blinded NCA kimhuang 2023-10-14 11:53
    - Blinded review of PK data: History… Helmut 2023-10-15 10:26
      - Blinded review of PK data: History… kimhuang 2023-10-16 00:43
- open-label BE trials maintain blindness ElMaestro 2023-10-14 17:39
  - open-label BE trials maintain blindness kimhuang 2023-10-15 00:56
    - open-label BE trials maintain blindness dshah 2023-10-17 09:25
      - open-label BE trials maintain blindness kimhuang 2023-10-18 00:50

Is random numbers backup acceptable? How to do? neilfiona 2022-08-22 08:19
- Randomization for withdrawals / stand-by subjects Helmut 2022-08-22 09:36
  - Randomization for withdrawals / stand-by subjects neilfiona 2022-08-22 10:00
- Stand-by subjects Ohlbe 2022-08-22 10:43

Regulatory acceptance pre-mature discontinuation of study Vaibhav 2022-06-20 15:07
- Regulatory acceptance pre-mature discontinuation of study Helmut 2022-06-20 16:13
  - Regulatory acceptance pre-mature discontinuation of study Vaibhav 2022-06-21 14:26
    - Regulatory acceptance pre-mature discontinuation of study Helmut 2022-06-21 15:12
      - Regulatory acceptance pre-mature discontinuation of study dshah 2022-06-23 12:52
        
        Regulatory acceptance pre-mature discontinuation of study Vaibhav 2022-06-23 20:41

Effect group in full replicate Bioequivalence Laura Carreiras 2022-05-11 13:11
- Effect group in full replicate Bioequivalence dshah 2022-05-12 11:46
- Effect group in full replicate Bioequivalence mittyri 2022-05-14 22:30

Achievement of steady state qualityassurance 2022-04-04 10:27
- Achievement of steady state Helmut 2022-04-04 10:31

Biowaiver for lower strength Vishal S 2021-08-06 11:12
- Biowaiver for lower strength drgunasakaran1 2021-08-06 14:47
  - Biowaiver for lower strength Vishal S 2021-08-09 08:55
    - Biowaiver for lower strength luvblooms 2021-08-18 10:34

BE for a drug dosed on body weight Achievwin 2021-07-06 14:37
- BE for a drug dosed on body weight dshah 2021-07-17 11:46

Impact of COVID-19 on HV trials Silvia Giarcovich 2020-04-16 22:38
- Impact of COVID-19 on HV trials Ohlbe 2020-04-20 10:11
- Impact of COVID-19 on HV trials jag009 2020-04-21 21:04
- Impact of COVID-19 on HV trials janejanesandpiper 2021-05-26 16:26
- Impact of COVID-19 on HV trials drgunasakaran1 2021-06-03 06:06

Dose normalization Yura 2021-05-27 12:25
- Dose normalization Relaxation 2021-05-27 15:29
  - Dose normalization Yura 2021-05-28 10:22
    - Dose normalization mittyri 2021-05-31 12:42
      - Dose normalization Yura 2021-06-01 09:23

Comparative PK PVRC 2021-05-10 18:12
- Comparative PK? Helmut 2021-05-12 11:25
  - Comparative PK? PVRC 2021-05-12 15:48
    - Comparative PK? Helmut 2021-05-12 16:18
      - Comparative PK? jag009 2021-05-20 01:31
      - Comparative PK? PVRC 2021-05-20 07:41

Additional Group in Bioequivalence Study PVRC 2021-04-23 10:35
- Additional Group in Bioequivalence Study ElMaestro 2021-04-23 12:17
  - No – futile! – test for G×T, pleeze… Helmut 2021-04-23 15:14
- Additional Group in Bioequivalence Study ElMaestro 2021-04-23 12:27
  - Additional Group in Bioequivalence Study PVRC 2021-05-06 12:22

Missing three consecutive samples in the elimination phase PVRC 2021-04-23 07:24
- Missing three consecutive samples in the elimination phase ElMaestro 2021-04-23 08:40
  - Missing three consecutive samples in the elimination phase PVRC 2021-04-23 10:19
    - Suggestions Helmut 2021-04-23 10:34
- Missing three consecutive samples in the elimination phase Ohlbe 2021-04-23 14:50

List of reference drug Elzbieta 2021-03-15 19:56
- List of reference drug dshah 2021-03-16 06:15
- List of reference drug Helmut 2021-03-16 16:33

Dextromethorphan Rosy 2020-03-21 23:38
- Dextromethorphan pmohite 2020-06-08 08:49

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