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Register- EMA: What do I need if I wan to run an overdose study jag009 2020-01-28 20:12
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- Statistical evaluation and BE hypotheses in full replicate design Elena777 2020-01-28 07:02
- FDA: required BE between early phase and Phase 3 formulations? fno 2020-01-22 15:38
- no BE between early phase and Phase 3 formulations Helmut 2020-01-22 16:15
- no BE between early phase and Phase 3 formulations fno 2020-01-22 17:11
- FDA: required BE between early phase and Phase 3 formulations? Achievwin 2020-01-27 20:06
- no BE between early phase and Phase 3 formulations Helmut 2020-01-22 16:15
- Bioequivalence Acceptance criteria for in-vitro binding study in EMA submission Biostats 2020-01-24 08:19
- Bioequivalence of racemic drugs using non-steriospecific bio scorp2011 2012-01-12 13:21
- BE of racemic drugs (EMA vs. FDA) Helmut 2012-01-12 19:21
- BE of racemic drugs (EMA vs. FDA) scorp2011 2012-01-13 06:11
- BE of racemic drugs (EMA’s practice) Helmut 2012-01-13 16:02
- BE of racemic drugs (EMA’s practice) scorp2011 2012-01-16 13:08
- BE of racemic drugs (EMA’s practice) valivetiananth 2019-12-30 13:45
- BE of racemic drugs (EMA’s practice) Helmut 2019-12-30 14:35
- BE of racemic drugs (EMA’s practice) valivetiananth 2019-12-30 13:45
- BE of racemic drugs (EMA’s practice) scorp2011 2012-01-16 13:08
- BE of racemic drugs (EMA’s practice) Helmut 2012-01-13 16:02
- BE of racemic drugs (EMA vs. FDA) scorp2011 2012-01-13 06:11
- BE of racemic drugs (EMA vs. FDA) Helmut 2012-01-12 19:21
- Significance of Ctau,ss in steady state study Biostats 2019-12-20 07:51
- Relevance of Cτ,ss Helmut 2019-12-20 12:46
- biowaiver requirement for APAC (Asia Pacific) jag009 2019-12-18 04:45
- Informed Consent Document Review suchit_bhavsar 2019-12-11 11:22
- Informed Consent Document Review Ohlbe 2019-12-11 16:58
- Informed Consent Document Review WhiteCoatWriter 2019-12-11 19:36
- Clarification from Russian expert organization regarding telmisartan BE studies Beholder 2019-11-08 07:51
- Clarification from Russian expert organization… Helmut 2019-11-08 15:35
- Questions mittyri 2019-11-08 22:00
- Guesses & answers Helmut 2019-11-09 11:36
- intergender differences and consequences mittyri 2019-12-04 08:53
- intergender differences and no consequences Helmut 2019-12-04 11:23
- intergender differences and consequences mittyri 2019-12-04 08:53
- Questions Yura 2019-12-04 12:16
- Guesses & answers Helmut 2019-11-09 11:36
- Questions mittyri 2019-11-08 22:00
- Confusion from Russian expert organization Helmut 2019-12-03 12:19
- Clarification from Russian expert organization regarding telmisartan BE studies Mikalai 2019-12-09 18:27
- Clarification from Russian expert organization… Helmut 2019-11-08 15:35
- NDA study for Mexico jag009 2019-12-06 16:19
- Cmax ER = Cmax IR ? Helmut 2019-12-06 16:41
- Cmax ER = Cmax IR - the only option mittyri 2019-12-06 17:08
- Cmax ER = Cmax IR - the only option Helmut 2019-12-06 17:36
- Cmax ER = Cmax IR ? jag009 2019-12-06 17:38
- Cmax ER = Cmax IR ? Helmut 2019-12-06 17:45
- Cmax ER = Cmax IR ? jag009 2019-12-06 21:21
- Cmax ER = Cmax IR ? Yura 2019-12-06 22:40
- Cmax ER = Cmax IR ? jag009 2019-12-09 18:15
- Cmax ER = Cmax IR ? Yura 2019-12-06 22:40
- Cmax ER = Cmax IR ? jag009 2019-12-06 21:21
- Cmax ER = Cmax IR ? Helmut 2019-12-06 17:45
- Cmax ER = Cmax IR - the only option mittyri 2019-12-06 17:08
- Cmax ER = Cmax IR ? Helmut 2019-12-06 16:41
- Generic submission in India jag009 2019-11-11 21:43
- Dead silence in India Helmut 2019-11-21 14:01
- Generic submission in India Ajit Thorat 2019-12-09 13:29
- Active metabolites: to measure or not to measure Elena777 2019-12-05 20:34
- Active metabolites: to measure or not to measure ElMaestro 2019-12-05 23:22
- Parent only. Chiral assay? Helmut 2019-12-06 00:26
- Active metabolites: to measure or not to measure ElMaestro 2019-12-05 23:22
- EMA Q&A vs EMA Product Specific guideline Averroes 2017-10-04 12:01
- Crushed Rivaroxaban? Averroes 2018-01-09 12:00
- Crushed Rivaroxaban? lukamar 2018-08-20 12:24
- specific BE study with administration of crushed/disintegrated tablet wienui 2019-12-03 18:20
- Crushed Rivaroxaban? lukamar 2018-08-20 12:24
- Crushed Rivaroxaban? Averroes 2018-01-09 12:00
- necessity of retention samples for pilot BE study Shuanghe 2019-11-25 13:05
- necessity of retention samples for pilot BE study Ohlbe 2019-11-25 15:16
- necessity of retention samples for pilot BE study Shuanghe 2019-11-25 18:00
- necessity of retention samples for pilot BE study ElMaestro 2019-11-25 17:38
- necessity of retention samples for pilot BE study Shuanghe 2019-11-25 18:42
- necessity of retention samples for pilot BE study nobody 2019-11-26 10:11
- necessity of retention samples for pilot BE study Ohlbe 2019-11-25 15:16
- Furosemide oral tablet Ibrahim Komeil 2019-11-18 09:03
Ing. Helmut Schütz