Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		96,273
Sample size calculations Sample size calculations	Power / Sample Size	GM	2020-01-17 13:42	1	2020-01-18 01:31	103
R in regulated environments FDA, again	R for BE/BA	Helmut	2019-08-28 14:58	1	2020-01-09 16:04	1,010
Steady State Bioequivalence Study Pre-dose samples	Design Issues	Pharma_88	2020-01-08 10:07	1	2020-01-09 12:36	326
3+3 Design 3+3 Design 3+3 Design Subject replacement Dose escalation and DMC Dose escalation and DMC	Design Issues	Pharma_88	2020-01-07 08:09	5	2020-01-08 10:41	332
The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time	Study Assessment	wienui	2020-01-05 18:22	4	2020-01-06 13:34	337
Normal Reference Range Vs Pre-defined site normal values Normal Reference Range Vs Pre-defined site normal values Hb level OT Hb level Hb level Hb level Hb level Hb level Participation databases Participation databases Participation databases Participation databases Participation databases Participation databases National databases‽ Great discussion Great discussion Great discussion WTF 😡 Great discussion National databases‽	Design Issues	cakhatri	2019-12-17 11:35	21	2020-01-02 18:42	1,217
Bioequivalence of racemic drugs using non-steriospecific bio BE of racemic drugs (EMA vs. FDA) BE of racemic drugs (EMA vs. FDA) BE of racemic drugs (EMA’s practice) BE of racemic drugs (EMA’s practice) BE of racemic drugs (EMA’s practice) BE of racemic drugs (EMA’s practice)	Regulatives / Guidelines	scorp2011	2012-01-12 13:21	6	2019-12-30 14:35	4,939
Group by sequence interaction Group by sequence interaction, an urban myth? pristine, genuine, holy, magnificent, inexplicable beautiful variation I love your subject line! Group effect, did you miss it? Group effect, did you miss it? Group effect: the endless story Group effect: the endless river Group effect: the endless river replicateBE solution with interactions replicateBE solution with interactions datasets issues datasets datasets lmer / lme What do you mean exactly? What do you mean exactly? ANOVA acc. to GL	General Statistics	Mutasim	2019-08-07 13:16	17	2019-12-30 12:32	2,340
Should those subjects have only one period data be included in BE analysis? No way! But... No way! But... No way! But... No way! But... No way! But... EMA guideline: no way...: EMA guideline: no way...: Slightly off topic, but related :-) Slightly off topic, but related :-) Slightly off topic, but related :-) Slightly off topic, but related :-) Slightly off topic, but related :-) 2.220446e-16 ≈ 0 The optional tolerance argument 2.220446e-16 ≈ 0 Sum of residuals ~ ε Sum of residuals ~ ε Wrong terminology Sum of residuals ~ ε	Design Issues	ssussu	2019-12-06 10:58	19	2019-12-28 13:55	1,451
Run R-packages in the browser Run R-packages in the browser Run R-packages in the browser Run R-packages in the browser	R for BE/BA	Helmut	2019-12-20 11:17	3	2019-12-20 21:49	555
Significance of Ctau,ss in steady state study Relevance of Cτ,ss	Regulatives / Guidelines	Biostats	2019-12-20 07:51	1	2019-12-20 12:46	470
BE study design issue 1×2 ≠ 2×1 1×2 ≠ 2×1 1×2 ≠ 2×1 x ◦ y = y ◦ x? BE study design issue ER vs. IR ER vs. IR	Design Issues	jag009	2019-12-13 23:26	7	2019-12-19 09:01	781
BEQ inquiry from health authority BEQ inquiry from health authority Method not sensitive enough Revalidation? Revalidation? Method not sensitive enough Method not sensitive enough Method not sensitive enough	Study Assessment	Aymanmy	2019-12-18 08:51	7	2019-12-19 08:21	703
Question：Using Phoenix WinNonlin Crossover object for Tmax test Phoenix WinNonlin Crossover object for Tmax test Phoenix WinNonlin Crossover object for Tmax test Tmax Hypothesis testing Tmax Hypothesis testing neglecting periods for Tmax Tmax Hypothesis testing SAP? Tmax Hypothesis testing Tmax Hypothesis testing	Nonparametrics	0521	2018-11-09 07:02	9	2019-12-18 16:55	4,191