Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Deconvolution sample size and design issues Deconvolution sample size and design issues Deconvolution sample size and exponential terms Deconvolution sample size and exponential terms	mittyri	2023-02-09 14:40	3	2023-02-10 09:34	4,223
Bioequivalence Across 3 Different Injection Site Bioequivalence Across 3 Different Injection Site Bioequivalence Across 3 Different Injection Site Two at a Time Two at a Time Two at a Time	XH7081	2022-09-21 20:22	5	2022-09-23 09:03	5,208
N calculation for trial about PK superiority Bracketing approach SmPC change is the whole thing N calculation for trial about PK superiority The efocus is faster absorption The efocus is faster absorption Non-parametric N Non-parametric N Non-parametric N	alejandro_jo1990	2022-09-01 14:40	8	2022-09-15 12:56	5,804
Choosing formula for sample size Exact (Owen’s Q) Exact (Owen’s Q) Exact (Owen’s Q) Exact (Owen’s Q) n iteratively from power aproximate n Exact (Owen’s Q) PowerTOST & FDA	Imph	2021-10-20 11:03	8	2022-09-01 14:31	6,690
Sample size for 3-way crossover Sample size for 3-way crossover Sample size for 3-way crossover AND or OR, that’s the question AND or OR, that’s the question AND or OR, that’s the question AND or OR, that’s the question AND or OR, that’s the question AND or OR, that’s the question The unknown ρ	chrisk	2022-08-09 18:55	9	2022-08-17 13:04	9,435
3 treatments with two-at-a-time approach 3 treatments with two-at-a-time approach 3 treatments with two-at-a-time approach	chrisk	2022-08-01 07:03	2	2022-08-01 15:56	5,022
BCS Class II & IV molecule BCS Class II & IV molecule BCS Class II & IV molecule in vivo ≠ in vitro in vivo ≠ in vitro in vivo ≠ in vitro in vivo ≠ in vitro Assumptions Assumptions	Mithu	2022-07-25 06:39	8	2022-07-25 11:26	5,163
Sample size for the pilot study by the PASS2021 software Pilot study (independent from software) Pilot study (independent from software) Rules of Thumb (PASS) Rules of Thumb (PASS)	dennis001	2022-07-24 10:56	4	2022-07-24 15:48	4,486
Probability to pass multiple studies Probability to pass multiple studies Power limbo Probability to pass multiple studies ?	Helmut	2021-02-19 12:02	3	2022-06-24 12:03	5,751
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() PowerTOST: sampleN.NTID() sampleN.NTID(): Example sampleN.NTID(): Example	pharm07	2022-05-03 11:23	10	2022-05-19 03:36	5,907
Target Power for BE Studies Target Power for BE Studies Target Power for BE Studies The guy in the penguin costume	Sereng	2022-05-12 17:45	3	2022-05-18 12:06	3,679
Back Calculating Sample Size Back Calculating Sample Size Back Calculating Sample Size Back Calculating Sample Size Back Calculating Sample Size PowerTOST: Total sample size Back Calculating Sample Size Algebra Algebra Parallel designs: Don’t use the (conventional) t-test!	Sereng	2022-05-12 17:40	9	2022-05-18 06:55	5,729
Sample Size Estimate in BE Studies Sample Size Estimate in BE Studies Sample Size Estimate in BE Studies	Sereng	2022-05-12 17:22	2	2022-05-18 03:58	3,432
Sample size and Replicated studies Sample size and Replicated studies Output of sampleN.scABEL() Output of sampleN.scABEL() - expanded limits ? Output of sampleN.scABEL() - expanded limits ? Output of sampleN.scABEL() Don’t use FARTSSIE for SABE Sample size larger than clinical capacity Sample size and Replicated studies	Bebac user	2022-03-23 09:38	8	2022-03-23 18:42	6,306
Sample Size "Efficiency" of Replicate CO vs. 2-way CO for NTID Sample Size "Efficiency" of Replicate CO vs. 2-way CO for NTID OT Follow the guidance (if possible) Follow the guidance (if possible) Now I got it!	Sereng	2022-01-30 23:11	5	2022-01-31 22:53	5,011