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Register- Publication of the final ICH M10 guideline Ohlbe 2022-06-10 10:48
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- Publication of the final ICH M10 guideline qualityassurance 2022-06-12 12:31
- Chromatograms Ohlbe 2022-06-14 11:37
- Publication of the final ICH M10 guideline qualityassurance 2022-06-12 12:31
- New FDA bioavailability guidance wienui 2022-04-15 09:44
- New FDA bioavailability guidance Relaxation 2022-04-16 13:59
- New FDA bioavailability guidance zizou 2022-04-16 18:22
- Excellent post! Helmut 2022-04-17 13:03
- New FDA bioavailability guidance zizou 2022-04-16 18:22
- New FDA bioavailability guidance Relaxation 2022-04-16 13:59
- Bempedoic Acid TBM BE study in SBOA dshah 2022-03-30 17:09
- Bempedoic Acid TBM BE study in SBOA jag009 2022-03-31 08:43
- Observational studies Helmut 2021-12-27 10:24
- Observational studies d_labes 2021-12-28 10:27
- … real-world evidence … Helmut 2022-02-11 10:38
- Observational studies d_labes 2021-12-28 10:27
- EMA BE-GL: Clarifications / Corrections? Helmut 2010-06-22 18:53
- Good news!? d_labes 2010-06-23 10:09
- Good news!? Helmut 2010-06-23 10:11
- Update Helmut 2011-02-05 18:48
- Q&A published 14 March 2011 Helmut 2011-03-16 13:44
- Q&A published 14 March 2011 ElMaestro 2011-03-16 14:20
- Phoenix/WinNonlin 6.1.0.173 Helmut 2011-03-17 04:23
- ANOVA party prevails d_labes 2011-03-17 11:00
- THX! Helmut 2011-03-19 02:59
- Outlier d_labes 2011-03-24 11:55
- Outliers - yes, but how? Helmut 2011-03-24 15:09
- Questions and Ambiguities d_labes 2011-03-28 14:16
- Residuals and Outliers in Replicate Design Crossover Studies d_labes 2011-04-04 08:53
- Outliers - yes, but how? Helmut 2011-03-24 15:09
- Info requested ElMag 2011-03-24 12:45
- Confused as well... Helmut 2011-03-24 16:50
- Outlier d_labes 2011-03-24 11:55
- THX! Helmut 2011-03-19 02:59
- Q&A published 14 March 2011 Priyanka_S 2011-03-21 14:28
- SAS code: Warning d_labes 2011-03-21 16:08
- Copy & paste Helmut 2011-03-21 22:38
- Subtleties, flaws, questions d_labes 2011-03-22 09:24
- Subtleties, flaws, questions Helmut 2011-03-27 20:35
- Not estimable in the model The user 2017-03-14 10:16
- Not estimable in the model ElMaestro 2017-03-14 11:02
- Not estimable in the model The user 2017-03-14 12:13
- Not estimable in the model ElMaestro 2017-03-14 12:41
- Not estimable in the model The user 2017-03-14 12:13
- Not estimable in the model Helmut 2017-03-18 21:59
- Food not the same between groups Beholder 2021-11-10 14:35
- Food not the same between groups ElMaestro 2021-11-17 09:50
- Food not the same between groups Beholder 2021-11-10 14:35
- Not estimable in the model ElMaestro 2017-03-14 11:02
- Not estimable in the model The user 2017-03-14 10:16
- Subtleties, flaws, questions Helmut 2011-03-27 20:35
- Subtleties, flaws, questions d_labes 2011-03-22 09:24
- Copy & paste Helmut 2011-03-21 22:38
- SAS code: Warning d_labes 2011-03-21 16:08
- Q&A published 14 March 2011 Helmut 2011-03-16 13:44
- Update Helmut 2011-02-05 18:48
- Good news!? Helmut 2010-06-23 10:11
- Good news!? d_labes 2010-06-23 10:09
- English translation of Japanese guidelines Ohlbe 2021-10-26 11:48
- GCC guidelines v3.0 Helmut 2021-10-25 20:03
- 4th GBHI report Helmut 2021-09-29 18:03
- FDA guideline on BE, draft August 2021 ElMaestro 2021-08-23 14:42
- FDA guideline on BE, draft August 2021 Helmut 2021-08-23 15:31
- FDA guideline on BE, draft August 2021 Achievwin 2021-09-08 04:09
- Bias correction unveiled Helmut 2021-09-10 20:47
- FDA guideline on BE, draft August 2021 Achievwin 2021-09-08 04:09
- FDA guideline on BE, draft August 2021 Achievwin 2021-08-23 21:35
- FDA guideline on BE, draft August 2021 Helmut 2021-08-23 23:46
- FDA guideline on BE, draft August 2021 Helmut 2021-08-23 15:31
- WHO: scaling for AUC? Ohlbe 2017-06-12 13:29
- WHO: Chapeau! Helmut 2017-06-12 23:31
- WHO: Chapeau! ElMaestro 2017-06-13 00:08
- WHO: Chapeau! nobody 2017-06-13 09:28
- WHO: Chapeau! Helmut 2019-06-10 11:23
- WHO: Chapeau! ElMaestro 2019-06-11 18:51
- WHO: Chapeau! ElMaestro 2017-06-13 00:08
- WHO: scaling for AUC confirmed Ohlbe 2021-07-02 10:31
- No comparison of variabilities any more? Helmut 2021-07-02 15:11
- WHO: scaling for AUC confirmed kratos 2021-08-03 10:38
- EMA: scaling for AUC = utopia Helmut 2021-08-03 12:54
- WHO: Chapeau! Helmut 2017-06-12 23:31
- EMA: Guideline on computerised systems and electronic data in clinical trials Helmut 2021-06-30 10:41
- Validation! mittyri 2021-06-30 16:26
- WHO guideline on data integrity Ohlbe 2021-04-08 11:03
- FDA: ANDA during COVID-19 pandemic Helmut 2021-01-19 17:27
- WHO frequent deficiencies in protocols and reports Ohlbe 2020-12-04 12:04
- WHO frequent deficiencies in protocols and reports ElMaestro 2020-12-04 14:10
- CI inclusion ≠ TOST Helmut 2020-12-04 20:30
- CI inclusion ≠ TOST d_labes 2020-12-05 16:19
- CI inclusion ≠ TOST ElMaestro 2020-12-05 16:49
- CI inclusion ≠ TOST d_labes 2020-12-07 11:39
- CI inclusion ≠ TOST Helmut 2020-12-06 22:09
- CI inclusion operationally identical to TOST d_labes 2020-12-07 11:11
- WHO lamenting about terminology? Helmut 2020-12-07 13:02
- WHO lamenting about terminology? ElMaestro 2020-12-07 14:54
- WHO lamenting about terminology? d_labes 2020-12-07 15:35
- WHO lamenting about terminology? Helmut 2020-12-07 13:02
- CI inclusion operationally identical to TOST d_labes 2020-12-07 11:11
- CI inclusion ≠ TOST ElMaestro 2020-12-05 16:49
- CI inclusion ≠ TOST d_labes 2020-12-05 16:19
- CI inclusion ≠ TOST Helmut 2020-12-04 20:30
- WHO frequent deficiencies in protocols and reports Helmut 2020-12-22 19:00
- "obtain balanced groups" vs randomisation ElMaestro 2020-12-23 08:12
- WHO frequent deficiencies in protocols and reports ElMaestro 2020-12-04 14:10
- Dasatinib EMA, April 2020 ElMaestro 2020-06-21 11:49
- What a relief! Helmut 2020-06-21 14:12
Ing. Helmut Schütz