Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Generic radiopharmaceuticals	Peregrin	2018-03-02 12:05	0		2,171
Agreement between Russia and Belarus for clinical trials (BE)	Beholder	2018-02-28 08:00	0		2,305
T>MIC for Anti microbial is sufficient to show therapeutic efficacy T>MIC for Anti microbial is sufficient to show therapeutic efficacy T>MIC for Anti microbial is sufficient to show therapeutic efficacy T>MIC for Anti microbial is sufficient to show therapeutic efficacy Therapeutic Occupancy Time Therapeutic Occupancy Time	heritage	2018-02-17 07:32	5	2018-02-18 06:19	6,004
Body surface area	Rock	2018-02-12 09:47	0		2,070
BE studies register in EU BE studies register in EU BA studies register in EU BE studies register in EU BE studies register in EU EU Clinical Trials Register: useless? EU Clinical Trials Register: useless? these days only? EU Clinical Trials Register: useless? EU Clinical Trials Register: useless? EU Clinical Trials Register: useless? EU Clinical Trials Register: useless? EU Clinical Trials Register: useless? Studies outside the EU/EAA: Zero? Studies outside the EU/EAA: Zero? Data base corrupted?	Beholder	2018-01-19 11:56	15	2018-01-24 21:51	13,588
BE studies wrt Indian approval	murali	2018-01-23 09:49	0		2,138
FDA Good ANDA submission practices Jan-2018 draft Need to know or nice to know	nobody	2018-01-18 15:11	1	2018-01-18 14:36	3,506
Is a Chiral method required? Racemate vs. enantiomer? Racemate vs. enantiomer? Racemate vs. enantiomer? Racemate vs. enantiomer?	xtianbadillo	2018-01-16 16:02	4	2018-01-18 09:55	5,466
Health Canada: Data format Health Canada: Data format Data integrity? Health Canada: 2012 guidance	Helmut	2018-01-15 12:32	3	2018-01-16 12:07	5,111
Russian «Экспертами» and their hobby Low power of Group-by-Treatment interaction Let’s forget the Group-by-Treatment interaction, please! Let’s forget the Group-by-Treatment interaction, please! Some answers Some answers Example Sensitivity of term? Simulations loosing specificity due to low sensitivity loosing specificity due to low sensitivity Loss in power Interval between groups IMP handling IMP handling Loss in power No convergence in JMP and Phoenix WinNonlin Ouch?!??? Russian «Экспертами» and their hobby be careful with mixed models be careful with mixed models p-value(s) in model 2 Russian «Экспертами» following the EEU GLs Russian «Экспертами» following the EEU GLs Penalty for carelessness Russian «Экспертами» following the EEU GLs Russian «Экспертами» following the EEU GLs Belarus = member of the EEU Belarus = member of the EEU Trying your model for EEU Trying your model for EEU help us to stop it, please... help us to stop it, please... regulators convinced by science? regulators convinced by science? Чёрт побери! regulators convinced by science? Excuse me Excuse me	Helmut	2017-04-29 00:46	38	2018-01-10 19:38	38,761
major Reasons for RTR	Achievwin	2018-01-04 16:06	0		2,071
FDA Draft guidance on Good ANDA Submission Practices	BRB	2018-01-03 21:42	0		2,512
Pentosan polysulfate BE recommendation of sep, 2012	bharathi	2018-01-03 07:44	0		2,361
Non-compartmental analysis Non-compartmental analysis	M.tareq	2017-12-31 17:17	1	2017-12-31 16:56	4,116
EMA Product Specific GL EMA Product Specific GL tlag‽ tlag‽ tlag‽ tlag‽ tlag‽ tlag‽ tlag‽ tlag‽	mmw	2017-07-14 14:50	9	2017-12-21 14:57	11,712