Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		109,518
randomization randomization randomization randomization package randomizeBE for R on steroids Randomization of gender Simplified R-code Simplified R-code Updated R-code Gender in crossover Gender in crossover Sex in crossover Sex in crossover OT: Sex / gender OT: Sex / gender OT: Sex / gender Updated R-code	R for BE/BA	Ana Cristina	2018-02-23 21:33	16	2020-04-08 12:31	8,058
Tegaserod analytical method	Regulatives / Guidelines	Ayman Rabayah	2020-04-08 11:23	0		24
Meets primary objective but not secondary objective Meets primary objective but not secondary objective Meets primary objective but not secondary objective Meets primary objective but not secondary objective Meets primary objective but not secondary objective	Study Assessment	Brus	2020-03-27 17:22	4	2020-04-06 19:41	258
Claim of Categorical Exclusion (21 CFR)	Regulatives / Guidelines	ping4santosh	2020-04-06 13:55	0		55
Dissolution and bracketing - EMA Dissolution and bracketing - EMA Dissolution and bracketing Dissolution and bracketing Dissolution and bracketing (EMA)	Regulatives / Guidelines	Susanh	2020-03-19 18:39	4	2020-04-04 08:42	1,629
Statistical evaluation and BE hypotheses in full replicate design Inflation of the TIE as well Inflation of the TIE as well Tricky… Tricky… Terrible… Tricky… Deep shit Deep shit Deep shit Deep shit Deep shit Deep shit Deep shit Flawed evaluation accepted Flawed evaluation accepted Flawed evaluation accepted Flawed evaluation accepted Flawed approach even if accepted 😡 Flawed approach even if accepted 😡 misunderstanding misunderstanding misunderstanding The globe is flat! Tricky… Tricky… Tricky… ABE vs. ABEL zigzag zigzag zigzag helter-skelter helter-skelter Inflation of the TIE as well Inflation of the TIE as well Inflation of the TIE as well Fishing in the dark Statistical evaluation and BE hypotheses in full replicate design TIE, repeat once more please...	RSABE / ABEL	Elena777	2020-01-28 07:02	38	2020-04-02 12:41	10,389
Bonferroni and Bartlet's tests	Study Performance	Achievwin	2020-03-31 21:37	0		113
Impact of COVID-19 on HV trials Impact of COVID-19 on HV trials Impact of COVID-19 on HV trials Impact of COVID-19 on HV trials	Study Performance	Laura R	2020-03-22 08:58	3	2020-03-31 03:09	1,363
Clinical trials in Corona (Covid-19) time. What I am missing.... What I am missing....	Regulatives / Guidelines	wienui	2020-03-29 07:15	2	2020-03-29 09:26	257
MR generic application MR generic application MR generic application MR generic application	Regulatives / Guidelines	Mikkabel	2020-03-16 16:40	3	2020-03-27 21:20	2,232
Steady State Bioequivalence Study Pre-dose samples Study design multiple dose stuy - circadian PK	Design Issues	Pharma_88	2020-01-08 10:07	2	2020-03-26 17:29	2,813
protocol amendment that may trigger Group effect test protocol amendment that may trigger Group effect test	General Statistics	Silke	2020-03-24 08:52	1	2020-03-24 09:07	938
Dextromethorphan	Study Performance	Rosy	2020-03-21 23:38	0		751
Outlier Test using R-Software and Phoenix WinNonlin software in the BE Outlier Test using R-Software and Phoenix WinNonlin software in the BE Studentized & standardized residuals Outlier Test using R-Software: Lund test Outlier Test using R-Software: Lund test Outlier Test using R-Software: Lund test bear for outlier detection analysis?	Outliers	udayk	2020-03-06 09:00	6	2020-03-20 14:45	3,434