Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		158,722
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	26
Back Calculating Sample Size Back Calculating Sample Size Back Calculating Sample Size Back Calculating Sample Size Back Calculating Sample Size Algebra	Power / Sample Size	Sereng	2022-05-12 17:40	5	2022-05-16 15:01	202
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	135
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	119
Handling large Extrapolated AUC Values residual area < 20% for more than 80% subjects	Regulatives / Guidelines	Sereng	2022-05-12 17:17	1	2022-05-14 22:06	68
Sample Size Estimate in BE Studies Sample Size Estimate in BE Studies	Power / Sample Size	Sereng	2022-05-12 17:22	1	2022-05-13 02:02	87
Target Power for BE Studies Target Power for BE Studies	Power / Sample Size	Sereng	2022-05-12 17:45	1	2022-05-12 22:23	74
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	73
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()	Power / Sample Size	pharm07	2022-05-03 11:23	7	2022-05-11 13:19	360
Slides from FDA's Generic Drug Forum 2022 Slides from FDA's Generic Drug Forum 2022	Conferences / Workshops	Ohlbe	2022-05-09 12:00	1	2022-05-10 09:24	161
Test statistic about Tmax Wilcoxon signed rank test Wilcoxon-Mann-Whitney! Wilcoxon-Mann-Whitney! Wilcoxon-Mann-Whitney PMID Wilcoxon-Mann-Whitney! choice of result No significance testing in BE	Nonparametrics	libaiyi	2018-06-19 08:15	7	2022-05-09 10:22	6,743
Asymmetric margins in PK study θ2 = 1 / θ1	PK / PD	msmnainar	2022-05-06 07:22	1	2022-05-06 09:32	185
ICH guideline M10 on BA method validation Stock solutions for CCs and QCs ICH guideline M10 on BA method validation	Regulatives / Guidelines	PSU	2022-05-03 15:53	2	2022-05-05 11:47	270
R v4.2.0 (Vigorous Calisthenics) and bear	🇷 for BE/BA	yjlee168	2022-05-03 03:16	0		146