Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		118,880
Is Cmax 95% Upper bound 0.0024 = Zero? 0.0024 > 0 ■ 0.0024 > 0 ■	RSABE / ABEL	Sereng	2020-10-22 20:30	2	2020-10-23 07:06	208
Thailand FDA Bioequivalence Guideline Thailand FDA Bioequivalence Guideline	Regulatives / Guidelines	Pharma_88	2020-10-22 06:49	1	2020-10-22 09:16	129
bear: it's time to say goodbye So sad! So sad! THX! bear: it's time to say goodbye bear: it's time to say goodbye bear: it's time to say goodbye Thanks!	R for BE/BA	yjlee168	2020-10-20 09:53	7	2020-10-21 20:07	585
Russia BE Study Russia BE Study Russia BE Study Russia BE Study Red Book? Red Book? Yeah... Red Book? Yeah... Red Book? Yeah... Russia BE Study Russia BE Study Russia BE Study Russia BE Study Russia BE Study Russia BE Study Russia BE Study Russia BE guidelines	Regulatives / Guidelines	Anand	2015-03-27 05:28	15	2020-10-21 10:42	5,407
Data manipulation / fraud in BE	Study Assessment	ElMaestro	2020-10-21 09:56	0		143
Multiple dose design Sample size CV of Css,max ≤ CV of Cmax Multiple dose design Sample size Sample size based on worst case Multiple dose design Sample size	Power / Sample Size	Researcher101	2020-10-14 10:21	4	2020-10-20 06:43	357
Au sujet de la conservation du plasma frais congelé vierge Conservation du plasma frais congelé vierge - storage of blank plasma OT: Preferred language in the forum OT: Preferred language in the forum OT: Preferred language in the forum OT: Preferred language in the forum OT: Preferred language in the forum Just to annoy Helmut Easy, Fritz!	Bioanalytics	Developper bioanalyste	2020-10-14 16:33	8	2020-10-19 20:42	773
Sample size for NTI using FDA method by excel macro Sample size for NTI using FDA method by excel macro Sample size for NTI using FDA method by excel macro Simulating studies in Excel not possible Simulating studies in Excel not possible Simulating studies in Excel not possible Simulating studies in Excel not possible may be possible -> Simulating studies in Excel not possible Simulating studies in Excel possible but slow 🐌 Have you upgraded to R v4.0.3 yet? Run on R v4.0.3	Power / Sample Size	dshah	2020-10-16 06:20	10	2020-10-19 12:12	948
FARTSSIE v2.5	Software	Helmut	2020-10-18 11:09	0		146
Retention period and quantity for Malaysian submission Retention period and quantity for Malaysian submission Retention period and quantity for Malaysian submission	Regulatives / Guidelines	Sriramprasad	2020-07-18 09:06	2	2020-10-17 13:54	1,284
Linear and Non-linear pharmacokinetics Linear and Non-linear pharmacokinetics Linear and Non-linear pharmacokinetics Linear and Non-linear pharmacokinetics Linear and Non-linear pharmacokinetics OT: The Wild Bunch	PK / PD	Sridhar.E	2020-10-08 12:23	5	2020-10-16 15:38	481
bioequivalence criteria for NTID bioequivalence criteria for NTID bioequivalence criteria for NTID GMR not relevant in ABE Presentation of data in report and SAS output bioequivalence criteria for NTID	Regulatives / Guidelines	Biostats	2018-03-29 12:39	5	2020-10-15 16:12	4,226
Parallel design from crossover CV No relationship between inter- and intra-subject CV No relationship between inter- and intra-subject CV	Power / Sample Size	arl_stat	2020-10-14 06:39	2	2020-10-14 15:02	248
statistical calculation procedures for 4 arm studies 4 periods (BE fed & fasting)	General Statistics	Loky do	2020-10-12 23:38	1	2020-10-12 23:58	193