Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
⚠️ Error 406 (in posting or replying) 📌	Tips / Tricks	Helmut	2022-10-29 17:00	0		3,315
Requesting data for a publication 📥 ♻️ 🚀 📌	General Statistics	Helmut	2023-02-23 10:46	0		11,864
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		168,959
how to construct confidence interval for un-transformed metric? how to construct confidence interval for un-transformed metric? how to construct confidence interval for un-transformed metric? Fieller’s confidence interval Fieller’s confidence interval Fieller’s confidence interval Rescue approaching – PowerTOST Rescue approaching – PowerTOST	Power / Sample Size	lizhao	2016-02-17 19:01	7	2024-11-28 23:15	9,346
3rd Bioequivalence Conference 26 Feb 2025 in Amsterdam	Conferences / Workshops	SMA	2024-11-28 11:33	0		152
ISR ISR ISR ISR ISR	Study Assessment	Loky do	2024-11-21 12:04	4	2024-11-27 14:27	442
First Point Cmax USFDA First Point Cmax (also ICH M13A) First Point Cmax (also ICH M13A) FDA M13A First Point Cmax (also ICH M13A)	Study Assessment	NK	2024-09-13 06:48	4	2024-11-27 13:50	1,351
Group-by-Treatment Interaction (another round)	Study Assessment	Helmut	2024-11-27 12:01	0		152
Possible reasons for group effect Group “effect” Possible reasons for group effect Possible reasons for group effect “Group-by-Treatment Interaction” “Group-by-Treatment Interaction” “Group-by-Treatment Interaction” OT: A choice between OT: A choice between OT: A choice between OT: A choice between OT: A choice between Groups: Overlapping CIs Groups: Overlapping CIs Groups: Overlapping CIs Groups: Overlapping CIs Groups: (Hardly‽) overlapping CIs Groups: (Hardly‽) overlapping CIs Groups: (Hardly‽) overlapping CIs Multiplicity? Groups	Design Issues	GM	2019-07-20 07:36	20	2024-11-26 08:15	7,025
ANVISA Guidelines on Participant Involvement in Clinical Trials	Regulatives / Guidelines	Rajul9	2024-11-24 18:19	0		222
ICHM13/High risk products ICHM13/High risk products ICHM13/High risk products ICHM13/High risk products ICHM13/High risk products ICHM13/High risk products Generic vs. hybrid	Regulatives / Guidelines	Mikkabel	2024-11-20 09:00	6	2024-11-22 13:17	604
Baseline correction vs non-baseline correction Baseline correction vs non-baseline correction Baseline correction vs non-baseline correction Baseline correction or supra-therapeutic dose Baseline correction or supra-therapeutic dose Baseline profile prior to each period? Baseline correction examples Baseline correction examples Baseline correction examples Baseline correction examples Baseline correction examples Postmenopausal women Baseline correction examples Baseline correction examples Postmenopausal women Postmenopausal women Baseline correction examples Baseline correction GeoMean and Median Geometric mean? Geometric mean? Geometric mean ≈ MLE of median Geometric mean ≈ MLE of median Bias? Bias? Baseline; another example Baseline; another example Baseline; another example Baseline; another example Slowly going OT: BE study simulations Slowly going OT: BE study simulations Religious debate Religious debate Religious debate Religious debate Slowly going OT: BE study simulations Slowly going OT: BE study simulations Slowly going OT: BE study simulations Business as usual Business as usual	Regulatives / Guidelines	jag009	2015-09-15 20:29	38	2024-11-16 11:12	23,626
Stratified randomisation in parallel BE studies and ANOVA model	Design Issues	BEQool	2024-11-14 12:42	0		290
install bear for R v4.4.1 under Windows 10/11 bear PK plots bear PK plots	🇷 for BE/BA	yjlee168	2024-10-06 21:11	2	2024-11-13 19:07	864
reason to exclude volunteer FDC: No measurable concentrations of one drug FDC: No measurable concentrations of one drug	Study Assessment	Loky do	2024-11-10 11:52	2	2024-11-10 12:48	551