Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	R’s	last Reply	V’s
sample size in bioequivalence studies sample size in bioequivalence studies sample size in bioequivalence studies sample size in bioequivalence studies sample size in bioequivalence studies sample size in bioequivalence studies sample size in bioequivalence studies Don’t use the formula by Chow, Shao, Wang! Don’t use the formula by Chow, Shao, Wang! Don’t use the formula by Chow, Shao, Wang! Don’t use the formula by Chow, Shao, Wang! Don’t use the Book by Chow, Shao, Wang! compromised power compromised power terminology terminology terminology sample size in bioequivalence studies	Power / Sample Size	daryazyatina	2017-08-03 09:34	17	2018-06-03 12:58	5,833
Rapid dissolution paradox	Dissolution / BCS / IVIVC	Melkor	2018-06-03 11:02	0		204
Oral Dispersible Tablet BE study USFDA submission Oral Dispersible Tablet BE study USFDA submission Oral Dispersible Tablet BE study USFDA submission	Regulatives / Guidelines	Ramesh Ramalingam	2018-04-13 10:52	2	2018-05-31 13:37	827
Retention samples Retention samples	Regulatives / Guidelines	priyanka12345	2018-05-09 15:57	1	2018-05-31 13:29	387
logical "and" in Google search logical "and" in Google search logical "and" in Google search logical "and" in Google search logical "and" in Google search Google: AND \| NOT	Tips / Tricks	Helmut	2018-05-28 16:48	5	2018-05-30 13:11	429
How to demonstrate the bioequivalence of sulodexide	Design Issues	bjkim97	2018-05-30 08:41	0		226
Power decrease for the highly correlation of AUCt and AUCinf Relevant: The PK metric with highest CV Relevant: The PK metric with highest CV Power of 2 independent TOSTs ≈ 2 simultaneous TOSTs with ρ=0 Power of 2 independent TOSTs ≈ 2 simultaneous TOSTs with ρ=0	Power / Sample Size	libaiyi	2018-05-23 08:40	4	2018-05-30 03:24	683
Selectivity sequence	Bioanalytics	chandru	2018-05-27 21:51	0		253
Concomitant medications experiment in method validation Concomitant medications experiment in method validation Concomitant medications experiment in method validation Enhancement from concomitant medications Enhancement from concomitant medications Enhancement from concomitant medications US FDA guidance	Bioanalytics	chandru	2018-02-14 07:31	6	2018-05-27 21:41	1,267
How to evaluate Stock solution stability according to EMA guideline How to evaluate Stock solution stability according to EMA guideline How to evaluate Stock solution stability according to EMA guideline	Bioanalytics	EKY	2018-05-23 03:59	2	2018-05-27 21:26	430
FDA: Biowaiver on lower strengths FDA: Biowaiver on lower strengths FDA: Biowaiver on lower strengths FDA: Biowaiver on lower strengths	Regulatives / Guidelines	jag009	2018-05-24 03:26	3	2018-05-26 17:21	527
New EMA guideline: Handling and shipping of IMPs	BE/BA News	Helmut	2018-05-24 15:45	0		354
100% raw data presentation in BA report 100% raw data presentation in BA report 100% raw data presentation in BA report 100% raw data presentation in BA report	Bioanalytics	jag009	2018-05-18 16:23	3	2018-05-24 03:20	552
New FDA BMV guideline What a monster! What a monster! Repeats as part of investigations, ja oder nein? Repeats as part of investigations, ja oder nein?	BE/BA News	Ohlbe	2018-05-21 16:28	4	2018-05-24 03:19	653
calculation of potency correction for Canada submission BE studies Homework Homework	Regulatives / Guidelines	Biostats	2018-05-23 19:23	2	2018-05-24 03:17	395
Replicate Study design for Brazil ABEL acc. to WHO Replicate Study design for Brazil	Regulatives / Guidelines	balakotu	2018-05-21 13:31	2	2018-05-22 20:51	425