- ICH M10 - Method validation - Anchoring points-reg ryraman2661 2024-03-20 04:51
- ICH M10 - Method validation - Anchoring points-reg Ohlbe 2024-03-20 10:50
- LBAs: Anchor points and model fitting Helmut 2024-03-21 17:42
- LBAs: Anchor points and model fitting ryraman2661 2024-03-25 12:28
- Tmax guideline Laura Carreiras 2024-02-16 15:05
- The minefield… Helmut 2024-02-16 15:59
- multiple dose studies Loky do 2024-01-21 16:15
- multiple dose studies dshah 2024-01-22 10:03
- Css level? dshah 2024-01-26 10:03
- multiple dose studies dshah 2024-01-22 10:03
- 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
- link to the post of BEBAC golden collection durga09 2023-10-10 10:43
- link to the post of BEBAC golden collection mittyri 2023-09-10 19:55
- Tmax 90% confidence interval Achievwin 2023-09-09 12:44
- 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 as per M10 guideline avinash 2023-07-27 13:16
- Sensitization test Kelen 2023-06-30 13:13
- 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
- Inaccuracy, precision acc. to IUPAC Helmut 2023-06-30 11:33
- 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
- SFDA BE GL v3.1 (also GCC?) khaledazeid 2023-07-01 18:09
- 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
- BE for the EMA Helmut 2023-05-15 13:40