Bioequivalence and Bioavailability Forum

Delayed Release Formulation -AUC truncated at 72 h (AUC(0-72h)) JP2030 2023-10-18 05:58
- EMA: No AUC(0-72h) for all MR products Helmut 2023-10-18 07:09

Application and test region of vasoconstrictor assay Kelen 2023-10-04 16:31
- Application and test region of vasoconstrictor assay dshah 2023-10-17 09:34

Tmax 90% confidence interval durga09 2023-09-08 10:21
- Tmax 90% confidence interval Achievwin 2023-09-09 12:44
  - link to the post of BEBAC golden collection mittyri 2023-09-10 19:55
    - link to the post of BEBAC golden collection durga09 2023-10-10 10:43
      - CI for difference in Tmax mittyri 2023-10-11 12:55
      - Tmax problems Helmut 2023-10-12 06:55

Test License rajasekharkakarla 2018-10-06 08:05
- Test License Obinoscopy 2018-10-06 12:58
- Test License wienui 2018-10-07 21:04
  - Remaining RLDs from pilot study qualityassurance 2023-09-28 12:29
    - Remaining RLDs from pilot study wienui 2023-09-28 18:12
    - Remaining RLDs from pilot study- retention sample? dshah 2023-10-03 17:27

Fed-fasted BE studies using different polymorphs london12 2009-08-25 14:21
- Fed-fasted BE studies using different polymorphs Helmut 2009-08-27 00:44
  - Fed-fasted BE studies using different polymorphs Ohlbe 2009-08-31 01:34
    - Submission of 'failed' studies Helmut 2009-08-31 15:36
      - Submission of 'failed' studies Ohlbe 2009-08-31 23:01
  - Fed-fasted BE studies using different polymorphs qualityassurance 2023-08-03 10:44

BCS class I (dispersible tablet): selection of reference product yuva 2023-08-01 11:23
- BCS class I (dispersible tablet): selection of reference product dshah 2023-08-01 12:36

non-accuracy and precision validation runs in ICH M10 guideline avinash 2023-06-30 09:28
- Inaccuracy, precision acc. to IUPAC Helmut 2023-06-30 11:33
  - Inaccuracy, precision acc. to IUPAC avinash 2023-07-03 08:21
- non-accuracy and precision validation runs in ICH M10 guideline Ohlbe 2023-07-10 09:29
  - non-accuracy and precision validation runs in ICH M10 guideline avinash 2023-07-28 05:25

Non-accuracy and precision validation runs as per M10 guideline avinash 2023-07-27 13:16

SFDA BE GL v3.1 (also GCC?) Helmut 2023-06-23 08:55
- SFDA BE GL v3.1 (also GCC?) khaledazeid 2023-07-01 18:09
  - SFDA BE GL v3.1 (GCC reference?) Helmut 2023-07-01 21:54
- SFDA BE GL v3.1 (also GCC?) wienui 2023-07-04 17:35
  - SFDA BE GL v3.1 (also GCC) Helmut 2023-07-04 19:46

Sensitization test Kelen 2023-06-30 13:13

Including duplicates of Low, medium and High QCs during analytical method validation Ayman Rabayah 2023-06-15 07:14
- Including duplicates of Low, medium and High QCs during analytical method validation dshah 2023-06-15 08:36

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

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