Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
Bioavailability-Sample size	pablomhdz	2019-02-06 16:45	0		245
Formulas to calculate sample size Formulas to calculate sample size Formulas to calculate sample size Hey, python is not so difficult :p experiments with a function optimization experiments with a function optimization	BE-proff	2019-02-04 12:12	5	2019-02-05 07:19	505
Sample Size calculation for ophthalmic PK endpoint study Simulations?	CBB	2019-01-30 12:06	1	2019-01-31 23:28	265
power_TOST VS statistical power of the ANOVA Power_80_20 Power_80_20 Power_80_20	MCELESTINO	2019-01-03 22:05	3	2019-01-04 21:39	477
AUC or Cmax for RSABE? Take them both	BE-proff	2018-12-24 17:58	1	2018-12-24 21:33	491
AUCsingle dose/Ctrough	Sundar.M	2018-12-20 09:30	0		370
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	532
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	751
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	17,249
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	1,421
Sample size calculation for CEP study	GM	2018-07-25 13:52	0		566
Power of Multiplicity Adjusted TOST	d_labes	2018-07-06 12:07	0		779
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	1,022
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	2,773
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	12,572
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	1,512

Bioequivalence and Bioavailability Forum 05:37 CET