Bioequivalence and Bioavailability Forum

ISR Loky do 2024-11-21 12:04
- ISR qualityassurance 2024-11-21 13:53
  - ISR Loky do 2024-11-22 12:16
    - ISR dshah 2024-11-27 12:46
    - ISR qualityassurance 2024-11-27 14:27

First Point Cmax USFDA NK 2024-09-13 06:48
- First Point Cmax (also ICH M13A) Helmut 2024-09-17 08:38
  - First Point Cmax (also ICH M13A) kimhuang 2024-11-27 08:49
    - FDA M13A Helmut 2024-11-27 13:50
- First Point Cmax (also ICH M13A) dshah 2024-11-27 12:50

Group-by-Treatment Interaction (another round) Helmut 2024-11-27 12:01

reason to exclude volunteer Loky do 2024-11-10 11:52
- FDC: No measurable concentrations of one drug Helmut 2024-11-10 12:33
  - FDC: No measurable concentrations of one drug Loky do 2024-11-10 12:48

Decrease in PSD: Need to repeat BE? qualityassurance 2024-07-02 08:32
- 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

Half life longer than literature (or well known) half-life jag009 2023-12-06 04:19
- Explain it in the report Helmut 2023-12-06 10:41
  - Explain it in the report jag009 2023-12-06 15:46
    - Don’t worry, be happy! Helmut 2023-12-06 16:30
      - Don’t worry, be happy! jag009 2023-12-07 16:36

Zero Data in Suppositories BE Test Siswanto 2023-08-12 09:18
- Zero Data in Suppositories BE Test dshah 2023-08-14 16:15
  - Zero Data in Suppositories BE Test Siswanto 2023-08-15 02:18
    - Zero Data in Suppositories BE Test dshah 2023-08-15 11:07

Outlier NK 2023-06-27 03:57
- Outlier dshah 2023-06-27 08:42
- Visual inspection of the fit! Helmut 2023-06-27 09:56

Isotretinoin Capsules 40 mg fed studies Venkata Chaitanya Reddi 2023-06-14 10:19
- Isotretinoin Capsules 40 mg fed studies dshah 2023-06-15 08:29
  - Isotretinoin Capsules 40 mg fed studies Venkata Chaitanya Reddi 2023-06-16 04:21
    - Isotretinoin Capsules 40 mg fed studies dshah 2023-06-16 08:27
      - Isotretinoin Capsules 40 mg fed studies Venkata Chaitanya Reddi 2023-06-16 08:48

Linagliptin/Metformin Hydrochloride film-coated tablets Venkata Chaitanya Reddi 2023-06-09 07:18
- Linagliptin/Metformin Hydrochloride film-coated tablets dshah 2023-06-09 11:51
  - Linagliptin/Metformin Hydrochloride film-coated tablets Venkata Chaitanya Reddi 2023-06-09 12:01

AUCtau and Ctau calculation Shatha 2022-08-27 01:36
- SAP? Helmut 2022-08-27 10:24
  - SAP? Shatha 2022-08-27 11:55

BE study results Evaluation Vaibhav 2022-06-14 20:57
- Sample size based on ‘overpowered’ study Helmut 2022-06-14 22:14
  - Sample size based on ‘overpowered’ study Vaibhav 2022-06-15 21:00
    - Sample size based on ‘overpowered’ study dshah 2022-06-16 10:43

Center term in Bioequivalence Study balakotu 2022-06-08 08:03
- Few subjects and many centers… Helmut 2022-06-08 11:56
- Center term in Bioequivalence Study ElMaestro 2022-06-08 13:14

Reanalysis of volunteers Loky do 2022-03-16 09:10
- Reanalysis of volunteers dshah 2022-03-16 16:37

William's OR Latin square design Bebac user 2022-03-10 11:45
- Williams’ OR Latin square design Helmut 2022-03-10 12:29
  - Williams’ OR Latin square design Bebac user 2022-03-10 19:26

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Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body. Leslie Z. Benet

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