- WHO Draft on BCS-based Biowaivers Helmut 2023-08-29 11:18
- ICH E6(R3) draft Guideline reaches Step 2 of the ICH process SMA 2023-05-24 08:37
- Validation of sample size estimations? Helmut 2023-05-29 08:34
- FDA draft guidance on transdermal systems Ohlbe 2023-04-13 08:37
- ICH M13A (IR BE) Helmut 2022-12-23 09:05
- ICH M13A (IR BE) Rasha_J 2023-01-16 05:27
- ICH M13A (IR BE) Helmut 2023-01-16 09:19
- ICH M13A (IR BE) SMA 2023-01-17 09:30
- ICH M13A (IR BE) dshah 2023-01-17 12:02
- ICH M13A (IR BE) Rasha_J 2023-01-18 09:53
- ICH M13A (IR BE) : FDA web site Ohlbe 2023-02-01 14:14
- Knowledge is power… Helmut 2023-02-09 12:34
- ICH M13A (IR BE): EMA consultation SMA 2023-02-08 09:10
- ICH M13A (IR BE): EMA comments received Helmut 2023-09-18 10:54
- ICH M13A (IR BE) Rasha_J 2023-01-16 05:27
- New guidance on Statistical Approaches to Establishing Bioequivalence Relaxation 2022-12-02 15:53
- A first look Helmut 2022-12-02 16:43
- A first look jag009 2022-12-02 17:58
- A first look BRB 2022-12-02 18:20
- SAS strikes back mittyri 2022-12-02 20:38
- SAS strikes back Helmut 2022-12-02 22:30
- Outliers? mittyri 2022-12-02 22:52
- Outliers? Helmut 2022-12-02 23:11
- SAS strikes back Achievwin 2023-02-07 07:23
- Outliers? mittyri 2022-12-02 22:52
- SAS strikes back Helmut 2022-12-02 22:30
- model-based BE? mittyri 2022-12-07 16:26
- model-based BE? Helmut 2022-12-10 10:13
- Hooker, Moellenhoff et al. are moving MBBE forward mittyri 2023-01-11 15:32
- model-based BE? SMA 2023-01-17 09:41
- model-based BE? Helmut 2022-12-10 10:13
- A first look PharmCat 2022-12-21 19:30
- A first look Rayhope 2023-01-06 06:56
- A first look jag009 2022-12-02 17:58
- Groups, sites… Helmut 2022-12-03 13:09
- SxF ElMaestro 2022-12-04 06:34
- SxF Helmut 2022-12-10 10:37
- New guidance on Statistical Approaches to Establishing Bioequivalence Mahmoud 2022-12-10 14:08
- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13
- Multi-group studies ad nauseam Helmut 2023-02-07 11:30
- Multi-group studies ad nauseam Achievwin 2023-02-25 16:18
- Webinar: Recording available Helmut 2023-04-01 10:38
- Multi-group studies ad nauseam Helmut 2023-02-07 11:30
- Speed kills Helmut 2023-02-07 13:02
- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13
- A first look Helmut 2022-12-02 16:43
- EMA Methodology Working Party Helmut 2022-10-01 09:53
- EMA Methodology Working Party dshah 2022-11-08 10:09
- ANVISA RDC Nº 742 Helmut 2022-09-12 10:27
- 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