Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Sample size with CV more than 100% Why not? Why not? Sample size for HVD's EMA: MR – ABEL for partial AUCs EMA: MR – ABEL for partial AUCs	Jay	2015-11-02 10:47	5	2015-11-02 13:48	9,123
BE studies for Inhalants BE studies for Inhalants BE studies for Inhalants	jag009	2015-10-19 20:32	2	2015-10-23 08:32	7,573
Power Calculation for Replicate study designs Power Calculation for Replicate study designs with SAS Beware of the partial replicate	balakotu	2015-09-24 11:55	2	2015-09-25 12:41	8,213
CV calculation CV calculation CV calculation CV(total) from CV(intra) and CV(inter)	avrahan	2014-09-17 21:40	3	2015-08-27 06:48	10,069
Adjusting for expected dropout-rate Percentage calculation Adjusting for expected dropout-rate - Nitpicking Good point! Good point! Copy paste error Copy paste error PowerTOST <1.2.7? PowerTOST <1.2.7?	Helmut	2015-06-17 12:33	8	2015-08-26 12:41	15,042
post hoc power post hoc power I’m sick of “100.0% power”	VSL	2015-07-01 19:37	2	2015-07-01 23:18	9,491
intra subject variability of Tetrabenazine	Debbie	2015-07-01 13:37	0		3,739
The power of post hoc power The power of post hoc power Ad hoc power Ad hoc power Ad hoc power Hypotheses in non-inferiority trials Hypotheses in non-inferiority trials Hypotheses in non-inferiority trials Hypotheses in non-inferiority trials Hypotheses in non-inferiority trials	The Outlaw Torn	2015-05-13 12:49	9	2015-06-29 06:24	11,870
CV inter-subject Hydroxychloroquine Hydroxychloroquine pooled / total CV Hydroxychloroquine Lousy review process Lousy review process Lousy review process Lousy review process Lousy review process Lousy review process Lousy review process	john john	2015-05-06 12:16	11	2015-05-28 14:10	14,781
Extrapolation CVinter (or CVtotal) from CVintra CVinter (or CVtotal) from CVintra OT: Drug Res OT: Drug Res completely OT completely OT CVinter (or CVtotal) from CVintra CVtotal ≠ CVintra + CVinter CVtotal ≠ CVintra + CVinter CVtotal ≠ CVintra + CVinter CVtotal ≠ CVintra + CVinter CVtotal ≠ CVintra + CVinter CVtotal ≠ CVintra + CVinter CVtotal ≠ CVintra + CVinter	john john	2015-05-13 13:36	14	2015-05-15 13:10	14,049
minimum number of subject in bioequivalence study minimum number of subject in bioequivalence study minimum number of subject in bioequivalence study “Overpowered” studies due to GLs “Overpowered” studies due to GLs “Overpowered” studies due to GLs Scientific Validation for the Sample Size Formula Basic maths Basic maths Reference for CI ⇒ MSE Reference for CI ⇒ MSE Failed study: power <80%! Failed study: power <80%! Reported 99.98%, correct 1.4% Reported 99.98%, correct 1.4% GMR ∉ AR ⇒ power <5% GMR ∉ AR ⇒ power <5%	khaoula	2014-09-27 11:14	16	2015-02-24 16:34	19,742
Different strengths – different ISV? Different strengths – different ISV? Different strengths – different ISV? Different strengths – thanks for advice Planning the study based on the previous results Planning the study based on the previous results Conservatism	mittyri	2014-12-21 18:04	6	2015-02-12 12:31	10,411
No of Vonteers requirment No of Vonteers requirment Sample size for scABE FDA (RSABE) vs. EMA (ABEL)	Srinetram	2015-01-08 06:41	3	2015-01-08 12:57	7,307
Sample size for PK linearity Sample size for PK linearity Sample size for PK linearity Sample size for PK linearity Sample size for PK linearity Weighting scheme Sample size for PK linearity Sample size for PK linearity Sample size for PK linearity - power model Power dose proportionality - power model - Correction Sample size for PK linearity Sample size for PK linearity Sample size for PK linearity Sample size for PK linearity dose proportionality vs. dose linearity dose proportionality vs. dose linearity	Kro	2009-05-19 10:56	15	2014-10-14 13:24	21,272
Sample size calculation for Ophthamal Drug Sample size calculation for Ophthamal Drug	MGR	2014-10-09 13:07	1	2014-10-09 11:31	5,287