Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		159,277
Another two... Another two... Dates Some more info EU Article 31 referral started Cheating Increased variability Increased variability Visualization Another two... Another two... Blind monitors or greedy sponsors? Blind monitors or greedy sponsors? Blind monitors or greedy sponsors? Blind monitors or greedy sponsors? (Cumulative) T/R-ratio vs. time Sponsors and CRO selection I still think that T/R-ratios are useful T/R-ratios are useful T/R-ratios are useful Bust the Buster complicate the assessor's life	GxP / QC / QA	Ohlbe	2021-09-16 23:41	21	2022-05-26 18:28	2,861
Sevelamer Carbonate In vitro binding study for EMA submission Sevelamer Carbonate In vitro binding study for EMA submission Sevelamer Carbonate In vitro binding study for EMA submission	Regulatives / Guidelines	jansari	2021-09-24 19:03	2	2022-05-26 13:28	773
Handling large Extrapolated AUC Values residual area < 20% for more than 80% subjects residual area < 20% for more than 80% subjects Exclusion for the FDA?	Regulatives / Guidelines	Sereng	2022-05-12 17:17	3	2022-05-23 11:43	239
Switchability with replicate design studies Switchability = IBE Switchability = IBE S × F interaction S × F interaction	Design Issues	Achievwin	2022-05-20 04:44	4	2022-05-20 23:32	193
Metida.jl: experimental Julia LinearMixedModel software Metida.jl: validation in progress… user structure Validation results Validation results Julia ≠ 🇷 Julia ≠ 🇷 Julia vs Phoenix WinNonlin (examples) Julia vs Phoenix WinNonlin (examples)	Software	PharmCat	2020-10-03 19:59	8	2022-05-20 17:54	2,100
Estimation of sample size for NIT using ISCV By R Estimation of sample size for NTI using ISCV By R PowerTOST PowerTOST PowerTOST PowerTOST PowerTOST PowerTOST: sampleN.NTID() PowerTOST: sampleN.NTID() sampleN.NTID(): Example sampleN.NTID(): Example	Power / Sample Size	pharm07	2022-05-03 11:23	10	2022-05-19 05:36	486
Target Power for BE Studies Target Power for BE Studies Target Power for BE Studies The guy in the penguin costume	Power / Sample Size	Sereng	2022-05-12 17:45	3	2022-05-18 14:06	183
Back Calculating Sample Size Back Calculating Sample Size Back Calculating Sample Size Back Calculating Sample Size Back Calculating Sample Size PowerTOST: Total sample size Back Calculating Sample Size Algebra Algebra Parallel designs: Don’t use the (conventional) t-test!	Power / Sample Size	Sereng	2022-05-12 17:40	9	2022-05-18 08:55	620
Sample Size Estimate in BE Studies Sample Size Estimate in BE Studies Sample Size Estimate in BE Studies	Power / Sample Size	Sereng	2022-05-12 17:22	2	2022-05-18 05:58	185
Hydrocortisone BE studies for UK	Design Issues	HallaGulla	2022-05-16 17:37	0		137
Bioequivalence study of sertraline HCL capsule Do your homework first	Regulatives / Guidelines	Vishal S	2022-05-16 14:40	1	2022-05-16 15:48	134
Effect group in full replicate Bioequivalence Effect group in full replicate Bioequivalence Effect group in full replicate Bioequivalence	Study Performance	Laura Carreiras	2022-05-11 13:11	2	2022-05-14 22:30	221
PK parameters PK parameters predefine in the Protocol whenever possible	PK / PD	Loky do	2022-05-11 15:45	2	2022-05-14 22:21	209
BE Confidence Interval Criteria: AUC(t) or AUC(inf) or both? BE Confidence Interval Criteria: AUC(t) or AUC(inf) or both?	Regulatives / Guidelines	Sereng	2022-05-12 17:14	1	2022-05-12 22:14	211