Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
Be study design issue. 1x2 # 2x1	jag009	2019-12-13 23:26	1	2019-12-14 00:42	40
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 :-)	ssussu	2019-12-06 10:58	10	2019-12-09 15:13	411
Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia OT: Speak with the regulator Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia WHO FDC Scenario 2 WHO FDC Scenario 2 EEU FDC Scenario 5.3.2 EEU FDC Scenario 5.3.2 EMA example Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia	Beholder	2019-11-13 12:47	19	2019-11-21 14:02	1,913
Bicalutamide having Long Half Life Bicalutamide: Crossover not realistic Bicalutamide: Crossover not realistic	udayk	2019-10-04 12:06	2	2019-10-10 09:10	608
Two 2x2 and one 6x3 crossover design Two 2x2 and one 6x3 crossover design	qzhou	2019-09-24 04:20	1	2019-09-24 10:57	671
Equivalency Studies for Injectables	ilee9009	2019-09-20 10:24	0		451
suggest suitable Sequence for Reference replicate and Two Different Test? Not sure whether it makes sense Not sure whether it makes sense Not sure whether it makes sense Not sure whether it makes sense	SP	2019-07-29 14:31	4	2019-08-05 09:27	980
Possible reasons for group effect Group “effect” Possible reasons for group effect Possible reasons for group effect “Group-by-Treatment Interaction”	GM	2019-07-20 07:36	4	2019-07-23 10:32	1,071
Steady State achievement	rajasekharkakarla	2019-07-03 10:02	0		577
Bio Batch Size Bio Batch Size Bio Batch Size Bio Batch Size	fedesalas	2018-09-12 17:46	3	2019-05-11 15:27	2,194
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 Two‐at‐a‐Time analysis in R fixed & mixed (dammit!) and a request to SASians Pooled vs IBD T-R in SAS from non-SASian Pooled vs IBD T-R in SAS from non-SASian mixed in R mixed in R (EMA B ≠ FDA)	acfalcao	2007-09-16 22:34	23	2019-03-24 01:23	18,212
Can we have two primary objectives? Can we have two primary objectives?	Achievwin	2019-01-24 17:50	1	2019-01-25 09:55	976
Acetylsalicyclic Acid + Glycine Tablet	Ramesh Ramalingam	2019-01-21 11:33	0		655
Dextromethorphan 90 mg in a single dose Dextromethorphan 90 mg in a single dose	heritage	2018-11-24 15:36	1	2018-11-26 10:33	1,352
BMI BMI limits BMI limits BMI limits BMI limits BMI limits	Amira Gouda	2018-10-30 10:48	5	2018-10-31 13:59	1,977