Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
LArger difference between upper and lower limit of 90% CI Larger difference between upper and lower limit of 90% CI	mirza baig	2018-11-28 16:14	1	2018-11-28 23:49	206
Power in case of a 3-arm BE study Power in case of a 3-arm BE study Power in case of a 3-arm BE study PowerTOST and 3-way parallel group BE study PowerTOST and 3-way parallel group BE study PowerTOST and 3-way parallel group BE study	Louis52	2018-11-14 22:40	5	2018-11-15 23:54	401
Power is getting high Power is getting high? Stop estimating post hoc power! Stop estimating post hoc power! Stop estimating post hoc power! Simulations Simulations Simulations Simulations Simulations Simulations α and 1–β α and 1–β α and 1–β α and 1–β Educate the IEC and regulators “Forced BE” 101 “Forced BE” 101 Would you be so kind answering our questions? Would you be so kind answering our questions? Yes, but why? Yes, but why? Optimists and pessimists "normal" GMR setting Example for discussion Example for discussion I prefer to play it safe Full ACK About GMR 1.10 Better 0.95 or 0.90 Yes, but why? Buffon's needle Buffon's needle 0.95 or 1.05 Buffon's needle Buffon's needle School maths School russian Offtop: Umschrift der westlichen Eigennamen auf Russisch EEU? EEU? EEU - pharmacokinetic equation??? EEU? Simulations Numbers don't lie	kms.srinivas	2017-12-26 07:39	44	2018-10-12 23:25	14,184
Lower bound for power of two combined TOST? Lower bound for power of two combined TOST? Lower bound for power of two combined TOST? Appendix D Appendix D Use of lower bound for power of two combined TOST Use of lower bound for power of two combined TOST Use of lower bound for power of two combined TOST	d_labes	2018-07-25 10:40	7	2018-08-07 11:50	1,135
Sample size calculation for CEP study	GM	2018-07-25 13:52	0		463
Power of Multiplicity Adjusted TOST	d_labes	2018-07-06 12:07	0		609
Sample size determination for William Design Williams’ design (all at once vs. two-at-a-time) Williams’ design (all at once vs. two-at-a-time)	Irene_I	2018-07-04 10:27	2	2018-07-05 11:04	822
Power in the pivotal study (EU) Stop estimating post hoc power! Stop estimating post hoc power! Confession Confession Confession Confession Silly-O-Meter: Syntax Silly-O-Meter: Syntax Stop estimating post hoc power! Eligible subjects? Don’t we deserve an answer?	valivetiananth	2018-05-31 13:49	11	2018-06-09 15:13	2,289
sample size in bioequivalence studies sample size in bioequivalence studies sample size in bioequivalence studies sample size in bioequivalence studies sample size in bioequivalence studies sample size in bioequivalence studies sample size in bioequivalence studies Don’t use the formula by Chow, Shao, Wang! Don’t use the formula by Chow, Shao, Wang! Don’t use the formula by Chow, Shao, Wang! Don’t use the formula by Chow, Shao, Wang! Don’t use the Book by Chow, Shao, Wang! compromised power compromised power terminology terminology terminology sample size in bioequivalence studies	daryazyatina	2017-08-03 09:34	17	2018-06-03 12:58	10,842
Power decrease for the highly correlation of AUCt and AUCinf Relevant: The PK metric with highest CV Relevant: The PK metric with highest CV Power of 2 independent TOSTs ≈ 2 simultaneous TOSTs with ρ=0 Power of 2 independent TOSTs ≈ 2 simultaneous TOSTs with ρ=0	libaiyi	2018-05-23 08:40	4	2018-05-30 03:24	1,261
BE parallel studies with more than 2 arms BE parallel studies with more than 2 arms BE parallel studies with more than 2 arms	Louis52	2018-04-18 20:18	2	2018-04-23 21:20	1,206
Levothyroxine Sample size and study design Levothyroxine Sample size and study design Levothyroxine Sample size and study design Levothyroxine Sample size and study design Levothyroxine Sample size and study design	lakshmiprasad	2018-04-11 15:09	4	2018-04-14 12:55	1,634
Power R WinNonLin Power R WinNonLin Power_TOST in PHX/WNL 6.4+ Power_TOST in PHX/WNL 6.4+ Power_TOST in PHX/WNL 6.4+ Power_TOST in PHX/WNL 6.4+ Power R WinNonLin Power of two stage design Power2Stage / power.2stage()	Yura	2018-01-23 15:02	8	2018-03-24 15:49	4,152
Within subject variability CVw pooled from CVwT and CVwR	MaggieSantos	2018-03-15 22:51	1	2018-03-16 12:56	1,458
Sample size for IVPT study	MGR	2018-02-22 06:17	0		815
Sample Size Estimation -Replicate design- BE limits Reference-scaling: Don’t use FARTSSIE! Reference-scaling: Don’t use FARTSSIE? Reference-scaling: Don’t use FARTSSIE! Reference-scaling: USE PowerTOST Reference-scaling: USE PowerTOST Reference-scaling: USE PowerTOST Reference-scaling: USE PowerTOST Use PowerTOST Use PowerTOST, not Endrényi L, Tóthfalusi L tables Precision in Endrényi L, Tóthfalusi L tables Precision of PowerTOST Precision of PowerTOST Precision of PowerTOST Precision of PowerTOST Precision of PowerTOST Precision of PowerTOST Reference-scaling: Don’t use FARTSSIE! Reference-scaling: Don’t use FARTSSIE!	cakhatri	2017-11-30 09:44	18	2018-02-09 20:15	7,668

Bioequivalence and Bioavailability Forum 02:46 CET