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Register- Baseline correction vs non-baseline correction jag009 2015-09-15 20:29
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- Baseline correction vs non-baseline correction Lucas 2015-09-16 14:16
- Baseline correction vs non-baseline correction Relaxation 2015-09-18 10:25
- Baseline correction or supra-therapeutic dose Helmut 2015-09-16 15:16
- Baseline correction or supra-therapeutic dose Ohlbe 2015-09-16 17:55
- Baseline profile prior to each period? Helmut 2015-09-16 18:15
- Baseline correction examples Helmut 2015-09-17 15:44
- Baseline correction examples Lucas 2015-09-18 14:19
- Baseline correction examples Helmut 2015-09-18 17:28
- Baseline correction examples Mauricio Sampaio 2016-02-07 03:05
- Baseline correction examples Lucas 2016-02-10 11:48
- Postmenopausal women Helmut 2016-02-10 12:26
- Baseline correction examples Mauricio Sampaio 2016-02-11 01:38
- Baseline correction examples Dr_Dan 2016-02-11 09:22
- Postmenopausal women Mauricio Sampaio 2016-02-12 03:24
- Postmenopausal women Dr_Dan 2016-02-15 17:45
- Postmenopausal women Mauricio Sampaio 2016-02-12 03:24
- Baseline correction examples Lucas 2016-02-10 11:48
- Baseline correction examples BEQool 2024-11-11 07:34
- Baseline correction GeoMean and Median mittyri 2024-11-11 11:20
- Geometric mean? Helmut 2024-11-11 14:53
- Geometric mean? BEQool 2024-11-14 08:19
- Geometric mean ≈ MLE of median Helmut 2024-11-14 09:54
- Geometric mean ≈ MLE of median Mahmoud 2024-11-15 11:26
- Geometric mean ≈ MLE of median Helmut 2024-11-14 09:54
- Geometric mean? BEQool 2024-11-14 08:19
- Geometric mean? Helmut 2024-11-11 14:53
- Baseline correction GeoMean and Median mittyri 2024-11-11 11:20
- Baseline correction examples Mauricio Sampaio 2016-02-07 03:05
- Baseline correction examples Helmut 2015-09-18 17:28
- Baseline correction examples Lucas 2015-09-18 14:19
- Baseline; another example Helmut 2015-09-18 17:16
- Baseline; another example nobody 2016-02-12 09:10
- Baseline; another example Helmut 2016-02-12 13:37
- Baseline; another example nobody 2016-02-12 14:08
- Slowly going OT: BE study simulations Helmut 2016-02-12 15:47
- Slowly going OT: BE study simulations nobody 2016-02-12 16:15
- Religious debate Helmut 2016-02-12 17:04
- Religious debate nobody 2016-02-12 17:26
- Religious debate ElMaestro 2016-02-13 12:53
- Religious debate nobody 2016-02-14 15:23
- Religious debate ElMaestro 2016-02-13 12:53
- Religious debate nobody 2016-02-12 17:26
- Religious debate Helmut 2016-02-12 17:04
- Slowly going OT: BE study simulations Ohlbe 2016-02-13 13:10
- Slowly going OT: BE study simulations Helmut 2016-02-13 15:02
- Slowly going OT: BE study simulations lizhao 2016-02-25 17:31
- Business as usual Helmut 2016-02-25 17:44
- Business as usual lizhao 2016-02-25 17:59
- Business as usual Helmut 2016-02-25 17:44
- Slowly going OT: BE study simulations lizhao 2016-02-25 17:31
- Slowly going OT: BE study simulations Helmut 2016-02-13 15:02
- Slowly going OT: BE study simulations nobody 2016-02-12 16:15
- Slowly going OT: BE study simulations Helmut 2016-02-12 15:47
- Baseline; another example nobody 2016-02-12 14:08
- Baseline; another example Helmut 2016-02-12 13:37
- Baseline; another example nobody 2016-02-12 09:10
- Baseline correction or supra-therapeutic dose Ohlbe 2015-09-16 17:55
- Baseline correction vs non-baseline correction Lucas 2015-09-16 14:16
- Shipment of Investigational Medicinal products qualityassurance 2024-10-30 13:47
- Shipment of Investigational Medicinal products Ohlbe 2024-11-05 22:11
- Shipment of Investigational Medicinal products qualityassurance 2024-11-06 14:15
- Shipment of Investigational Medicinal products Ohlbe 2024-11-05 22:11
- FDA: Update of PSGs to align with ICH M13A Helmut 2024-10-03 15:58
- FDA: ICH M13A, Q&A, PSGs, and a rant Helmut 2024-11-01 08:58
- "Dose or Strength to be Studied" in ICH M13A Darborn 2024-09-30 01:14
- "Dose or Strength to be Studied" in ICH M13A BEQool 2024-10-07 10:33
- "Dose or Strength to be Studied" in ICH M13A Darborn 2024-10-08 00:58
- "Dose or Strength to be Studied" in ICH M13A BEQool 2024-10-07 10:33
- Draft guideline on quality and equivalence of topical products – still stuck? mittyri 2024-09-14 20:24
- Patience… Helmut 2024-09-18 08:22
- MWP Ohlbe 2024-09-18 10:26
- Final & published Helmut 2024-10-03 11:44
- MWP Ohlbe 2024-09-18 10:26
- Patience… Helmut 2024-09-18 08:22
- ICH M13 Guidance and Health Canada AB661 2024-10-01 05:09
- ICH M13A/C and Health Canada Helmut 2024-10-01 06:29
- Pooling of studies? Helmut 2024-09-02 13:55
- coverage probability mittyri 2024-09-02 17:22
- M13 Ohlbe 2024-09-02 17:37
- M13 Q&A Helmut 2024-09-06 08:31
- Cholestyramine and colesevelam in Vitro binding studies jansari 2024-09-02 17:25
- Acute and Sub-acute toxicity studies for FDA ANDAs Achievwin 2024-08-05 18:50
- Acute and Sub-acute toxicity studies for FDA ANDAs NK 2024-08-06 04:06
- Acute and Sub-acute toxicity studies for FDA ANDAs Achievwin 2024-08-27 02:42
- Acute and Sub-acute toxicity studies for FDA ANDAs NK 2024-08-06 04:06
- EU Reference Medicinal Product – Flexible or Absolute? PE 2024-08-20 10:39
- EEA Reference Medicinal Product: Mandatory Helmut 2024-08-20 12:17
- Predose concentration more than 5 % of Cmax NK 2024-08-05 06:07
- FDC or isomers: C0 > 5 % of Cmax Helmut 2024-08-05 08:36
- FDC or isomers: C0 > 5 % of Cmax Achievwin 2024-08-05 19:08
- Carryover. A Never Ending Story. Helmut 2024-08-05 22:39
- Inducers/inhibitors Ohlbe 2024-08-08 18:09
- Inducers/inhibitors Helmut 2024-08-09 08:26
- FDC or isomers: C0 > 5 % of Cmax Achievwin 2024-08-05 19:08
- Predose concentration more than 5 % of Cmax qualityassurance 2024-08-05 12:48
- FDC or isomers: C0 > 5 % of Cmax Helmut 2024-08-05 08:36
- FDC with ascorbic acid qualityassurance 2024-07-23 08:08
- FDC with ascorbic acid Ohlbe 2024-07-23 09:55
- FDC with ascorbic acid qualityassurance 2024-07-23 10:13
- FDC with ascorbic acid Ohlbe 2024-07-23 09:55
- Brazil, Mexico: Proc GLM or Proc Mixed? jag009 2024-07-17 20:29
- Brazil, Mexico: Proc GLM? Helmut 2024-07-18 09:01
- Mexico: new guideline Ohlbe 2024-07-18 09:40
- Mexico: ABEL Helmut 2024-07-18 10:42
- Mexico: ABEL NK 2024-07-19 07:30
- Mexico: ABEL Helmut 2024-07-19 09:26
- Mexico: ABEL jag009 2024-07-23 19:43
- Mexico: ABEL Helmut 2024-07-19 09:26
- Mexico: ABEL NK 2024-07-19 07:30
- Mexico: ABEL Helmut 2024-07-18 10:42
- Mexico: new guideline Ohlbe 2024-07-18 09:40
- Brazil, Mexico: Proc GLM? Helmut 2024-07-18 09:01
- full replicate study for drug not highly variable - EMA perspective Ankit Parikh 2024-07-11 04:40
- EMA: Full replicate study Helmut 2024-07-15 09:13
- Need some clarity on eCTD module 5 jag009 2024-07-12 16:04
Ing. Helmut Schütz