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Register- ANVISA RDC Nº 742 Helmut 2022-09-12 10:27
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- ANVISA RDC Nº 749 dshah 2022-09-16 19:13
- ICH M12 (DDI studies) Helmut 2022-07-29 13:53
- Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology suchit_bhavsar 2022-06-29 07:37
- Publication of the final ICH M10 guideline Ohlbe 2022-06-10 10:48
- 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
- EMA: New product-specific guidances Helmut 2022-04-08 15:17
- How would you implement it? ElMaestro 2022-04-09 11:45
- Confuse a Cat Inc. Helmut 2022-04-09 18:40
- Confuse a Cat Inc. ElMaestro 2022-04-09 21:47
- Confuse a Cat Inc. Ohlbe 2022-04-11 11:29
- Confuse a Cat Inc. Helmut 2022-04-11 13:59
- So many questions, so few answers Helmut 2022-04-11 13:03
- Preliminary simulations Helmut 2022-04-30 14:59
- Preliminary simulations ElMaestro 2022-04-30 19:10
- Preliminary simulations Helmut 2022-05-01 15:56
- Revisions of the PSGLs final Helmut 2023-06-23 13:29
- Revisions of the PSGLs final dshah 2023-06-28 14:43
- EMA: No problems with many sampling time points… Helmut 2023-06-28 15:59
- New simulations & some desultory thoughts Helmut 2023-06-29 11:34
- SCNR. A heretic alternative. Helmut 2023-06-30 11:50
- Revisions of the PSGLs final dshah 2023-06-28 14:43
- Preliminary simulations ElMaestro 2022-04-30 19:10
- Simulated distributions Helmut 2022-05-02 13:43
- Confuse a Cat Inc. Ohlbe 2022-04-11 11:29
- Confuse a Cat Inc. ElMaestro 2022-04-09 21:47
- Confuse a Cat Inc. Helmut 2022-04-09 18:40
- How would you implement it? ElMaestro 2022-04-09 11:45
- 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
- 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
- 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
Ing. Helmut Schütz