Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
EU: Fed or fasting conditions for BE study EU: Fed state according to the reference’s SmPC EU: Fed state according to the reference’s SmPC	Farmacevt	2021-09-24 15:47	2	2021-09-27 19:44	1,316
Application of AI/Machine learning for BA/BE studies Suffering from Human Unintelligence Suffering from Human Unintelligence Application of AI/Machine learning for BA/BE studies	Achievwin	2021-08-17 19:31	3	2021-09-02 18:23	1,655
HVD Pilot: 3 candidates, 1 reference HVD Pilot: 3 candidates, 1 reference HVD Pilot: 3 candidates, 1 reference HVD Pilot: 3 candidates, 1 reference	Shah	2021-07-16 13:40	3	2021-07-20 07:31	2,142
Intrauterine Device – Levonorgestrel 52 mg Intrauterine Device – Levonorgestrel 52 mg Intrauterine Device – Levonorgestrel 52 mg Intrauterine Device – Levonorgestrel 52 mg	marianna.macera	2021-06-30 15:04	3	2021-07-02 15:18	1,147
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) Williams design 3-way Williams design 3-way Williams design 3-way Williams design 3-way Williams design 3-way Williams design 3-way Williams design 3-way Williams design 3-way Williams design 3-way Period effects in general Williams design 3-way	acfalcao	2007-09-16 22:34	34	2021-06-11 14:56	30,826
Food effects Food effects	prasad.v	2021-06-08 08:35	1	2021-06-09 04:06	1,250
partial AUCs for locally acting MR partial AUCs for locally acting MR partial AUCs for locally acting MR partial AUCs for locally acting MR	Susanh	2020-12-04 16:14	3	2021-05-31 06:47	2,394
bioequivalence if test and reference formulation having different strengths least common multiple of T and R least common multiple of T and R least common multiple of T and R least common multiple of T and R	Vishal S	2021-05-24 09:21	4	2021-05-25 22:23	1,723
Two-stage replicate design studies for RSABE Two-stage design ❌ RSABE Two-stage design ❌ RSABE Two-stage design & RSABE: Forget it!	Achievwin	2021-05-14 19:20	3	2021-05-19 18:40	1,668
Biowaiver for Emusion Dosage Form Biowaiver for Emusion Dosage Form	surajpatel	2021-05-11 10:27	1	2021-05-12 05:52	1,270
Exclusion due to adverse event State it in the SAP & observe it Exclusion due to adverse event	Loky do	2021-03-29 15:59	2	2021-03-31 12:43	1,894
BE study designing related doubts BE study designing related doubts	gsrao2022	2021-03-28 20:12	1	2021-03-28 22:41	1,411
Question raised by the PMDA Question raised by the PMDA Question raised by the PMDA	Helmut	2021-02-26 15:46	2	2021-03-19 17:06	1,839
Obeticholic Acid Study	Researcher101	2021-02-23 20:35	0		957
RLD strength for BE study 505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ 505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ Directive 2001/83/EC, Article 10(3) = hybrid	Brus	2021-01-21 14:24	3	2021-01-25 16:39	1,518