Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
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	10,425
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	870
Sample size calculation for CEP study	GM	2018-07-25 13:52	0		364
Power of Multiplicity Adjusted TOST	d_labes	2018-07-06 12:07	0		422
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	653
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	1,820
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	8,776
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	1,082
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	1,056
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	1,443
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	3,632
Within subject variability CVw pooled from CVwT and CVwR	MaggieSantos	2018-03-15 22:51	1	2018-03-16 12:56	1,221
Sample size for IVPT study	MGR	2018-02-22 06:17	0		727
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	6,320
Sample size for 4-period 4-sequence crossover BE study function sampleN.TOST of package PowerTOST Alpha adjustment in higher order crossover Deficiencies Deficiencies Deficiencies Deficiencies Deficiencies Deficiencies Deficiencies alpha... where is omega? α and no ω TIE for NTIDs TIE for NTIDs TIE for NTIDs TIE for NTIDs TIE for NTIDs TIE for NTIDs TIE for NTIDs TIE for NTIDs bow TIE for NTIDs bow TIE for NTIDs 111.11 for NTIDs 111.11 for NTIDs bow TIE for NTIDs	Bryony Simmons	2018-02-01 12:16	24	2018-02-06 12:34	5,400
Sample Size calculation for Clinical trials Sample Size calculation for Clinical trials	Mohamed Yehia	2018-02-04 11:42	1	2018-02-05 15:07	1,333

Bioequivalence and Bioavailability Forum 09:51 CEST