Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
Open Position at WHO	GxP / QC / QA	Helmut	2022-11-03 14:19	0		2,330
Bioequivalence Across 3 Different Injection Site Bioequivalence Across 3 Different Injection Site Bioequivalence Across 3 Different Injection Site Two at a Time Two at a Time Two at a Time	Power / Sample Size	XH7081	2022-09-21 20:22	5	2022-09-23 09:03	4,506
US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE?	Regulatives / Guidelines	jag009	2022-09-01 22:16	12	2022-09-20 14:02	5,933
replicateBE_xlsx datafile replicateBE: data input replicateBE: data input replicateBE: error in data input replicateBE: Data import	🇷 for BE/BA	roman_max	2020-06-10 17:32	4	2022-09-17 09:02	6,397
IVIVC calculations IVIVC calculations IVIVC calculations IVIVC calculations Mergers IVIVC calculations PCDCON ⇒ IVIVC calculations IVIVC calculations IVIVC calculations Minitab etc. Minitab etc. XL XL XL XL XL Broken link XL XL XL Any news? Good News PBPK IVIVC PBPK IVIVC PBPK IVIVC Good News Contact Contact XL Jean-Michel Jean-Michel Jean-Michel Jean-Michel Minitab etc. IVIVC calculations IVIVC calculations	Dissolution / BCS / IVIVC	mahendra	2013-10-24 16:10	35	2022-09-17 03:50	42,294
ANVISA RDC Nº 742 ANVISA RDC Nº 749	BE/BA News	Helmut	2022-09-12 10:27	1	2022-09-16 17:13	6,277
Initial dose and design issues abridged submission daily ER vs BID IR	Design Issues	alejandro_jo1990	2022-09-15 15:35	0		2,296
N calculation for trial about PK superiority Bracketing approach SmPC change is the whole thing N calculation for trial about PK superiority The efocus is faster absorption The efocus is faster absorption Non-parametric N Non-parametric N Non-parametric N	Power / Sample Size	alejandro_jo1990	2022-09-01 14:40	8	2022-09-15 12:56	4,895
strange question: An RLD (RS) which can be scored strange question: An RLD (RS) which can be scored strange question: An RLD (RS) which can be scored	Regulatives / Guidelines	jag009	2022-09-08 19:30	2	2022-09-14 15:25	3,429
T/R potency <5% T/R potency <5% T/R potency <5% T/R potency <5% T/R potency <5% T/R potency <5% T/R potency <5% T/R potency <5% T/R potency <5%	Regulatives / Guidelines	Achievwin	2022-09-07 18:22	8	2022-09-09 15:42	5,181
NCA PK NCA PK NCA PK bear on 🇷 ≥4.2	🇷 for BE/BA	Bebac user	2022-09-01 13:38	3	2022-09-04 13:33	5,171
Application of 90% CI for Ctau Do your homework first	Regulatives / Guidelines	Mithu	2022-09-01 06:55	1	2022-09-01 14:40	3,142
Choosing formula for sample size Exact (Owen’s Q) Exact (Owen’s Q) Exact (Owen’s Q) Exact (Owen’s Q) n iteratively from power aproximate n Exact (Owen’s Q) PowerTOST & FDA	Power / Sample Size	Imph	2021-10-20 11:03	8	2022-09-01 14:31	5,951
system and system2 in R system and system2 in R system and system2 in R system and system2 in R processx package tryCatch in R tryCatch in R tryCatch in R	Software	ElMaestro	2022-08-29 22:29	7	2022-09-01 12:07	4,514
Why was TRT (treatment) included in Random effect of PROC Mixed?	Regulatives / Guidelines	neilfiona	2022-09-01 11:58	0		2,346