Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
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	817
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	1,029
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	2,056
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	3,404
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	1,015
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	840
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	851
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	2,240
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	1,050
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	752
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	1,426
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	705
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	1,567
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	1,205
Sample size in fartssie No reference-scaling in FARTSSIE Sample size in fartssie	Bebac user	2022-01-21 19:43	2	2022-01-24 09:57	923