Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
Study which captures SD and SS PK Profiles A vs B A vs B ANDA or NDA? Modelling Modelling Modelling: SD+SS	jag009	2020-02-03 20:15	6	2020-02-04 12:38	839
Steady State Bioequivalence Study Pre-dose samples	Pharma_88	2020-01-08 10:07	1	2020-01-09 12:36	2,078
3+3 Design 3+3 Design 3+3 Design Subject replacement Dose escalation and DMC Dose escalation and DMC	Pharma_88	2020-01-07 08:09	5	2020-01-08 10:41	939
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‽	cakhatri	2019-12-17 11:35	21	2020-01-02 18:42	2,152
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	ssussu	2019-12-06 10:58	19	2019-12-28 13:55	2,035
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	jag009	2019-12-13 23:26	7	2019-12-19 09:01	1,170
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	2,489
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	822
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	905
Equivalency Studies for Injectables	ilee9009	2019-09-20 10:24	0		581
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	1,255
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	1,460
Steady State achievement	rajasekharkakarla	2019-07-03 10:02	0		693
Bio Batch Size Bio Batch Size Bio Batch Size Bio Batch Size	fedesalas	2018-09-12 17:46	3	2019-05-11 15:27	2,541
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	19,677