Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
★ New style sheet ★ ☠ New style sheet ☠	Tips / Tricks	Helmut	2019-03-12 15:01	1	2019-03-16 18:26	1,576
▼ Read before registering ▼	Tips / Tricks	Helmut	2016-04-14 23:39	0		56,926
Deletti tables for sample size Of historic(al) interest only Of historic(al) interest only Software validation – again and again Software validation – again and again Fiaker und Apfelstrudel Fiaker und Apfelstrudel Fiaker und Apfelstrudel Fiaker und Apfelstrudel Fiaker und Apfelstrudel White-box validation Power of Proc Power	Power / Sample Size	sury	2019-03-19 12:22	11	2019-03-20 22:09	244
Handling BLOQ values (Fisher Info etc.) Handling BLOQ values (Fisher Info etc.) The smartest solution An old solution old, obvious? Example ADA example My beloved Ada Handling BLOQ values (Fisher Info etc.) Handling BLOQ values (Fisher Info etc.) Don’t weight by 1/s²	Bioanalytics	mittyri	2019-03-16 14:41	10	2019-03-19 08:26	362
Three-way crossover BABE Studies Three-way crossover example data set Three-way crossover example data set Three-way crossover example data set Three-way crossover (WinNonlin) Three-way crossover (WinNonlin) Three-way crossover (WinNonlin) Three-way crossover (WinNonlin) Three-way crossover example data set Three-way crossover example data set Three-way crossover example data set Three-way crossover example data set Leave-One-Out (IBD) Leave-One-Out (IBD) Impact of pooled variance (bias, CI) carry (over?) Pseudo-periods Pseudo-periods	Design Issues	acfalcao	2007-09-16 22:34	17	2019-03-15 00:47	13,346
Draft ICH M10 published Consultation period? EU/EEA ICH M10 draft Multiple methods within a single trial Multiple methods within a single trial Multiple methods within a single trial Multiple methods within a single trial Multiple methods within a single trial one study, one method	Regulatives / Guidelines	Ohlbe	2019-03-03 23:18	9	2019-03-14 23:16	465
Chloropyramine BE study Pilot study Pilot study GRLS data GRLS data lucky sponsors	Power / Sample Size	Elena777	2019-03-13 17:17	5	2019-03-14 11:28	227
WHO draft guidance on good chromatography practices	Regulatives / Guidelines	Ohlbe	2019-03-12 11:45	0		145
Good bye! Fare well, Canary Wharf! And nevermore. Good bye! Fare well, Canary Wharf! And nevermore. Brexit	BE/BA News	Helmut	2019-03-11 23:40	2	2019-03-12 09:57	247
Warning: BE in ThothPro Warning: BE in ThothPro BE in ThothPro 4.3: alpha stage BE in ThothPro 4.3: alpha stage devil in the details ThothPro - Pro = professional?	Software	Helmut	2019-03-06 15:48	5	2019-03-11 15:03	413
SAAMnow Spring 2019 Workshop SAAMnow Spring 2019 Workshop Wow Programme Programme OT? - Gottlieb? OT? - Gottlieb?	Conferences / Workshops	Helmut	2019-03-03 17:24	6	2019-03-07 20:10	451
Dissolution similarity Dissolution similarity Dissolution similarity Mahalanobis distance - R code DDSolver, Mahalanobis distance and its 90% CI DDSolver, Mahalanobis distance and its 90% CI DDSolver, Mahalanobis distance and its 90% CI DDSolver, Mahalanobis distance and its 90% CI	Dissolution / BCS / IVIVC	Nirali	2010-11-10 11:13	7	2019-03-07 19:23	14,209
Outliers: The FDA follows the EMA Outliers: The FDA follows the EMA	BE/BA News	Helmut	2019-03-05 01:24	1	2019-03-06 19:23	316
Why BE testing use 90 CI Why BE testing use 90 CI Why BE testing use 90 CI one-sided / two-sided one-sided / two-sided one-sided / two-sided	General Statistics	akash	2019-02-23 08:39	5	2019-03-04 11:25	486
A weird CI A weird CI A weird CI	General Statistics	ElMaestro	2019-02-24 13:05	2	2019-03-03 23:09	573

Bioequivalence and Bioavailability Forum 22:26 CET