Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
3x3 or 2x4? 3x3 or 2x4? 3x3 or 2x4? 3x3 or 2x4? 3x3 or 2x4? 2x3x3 or 2x2x3 or 2x2x4? 2x3x3 or 2x2x3 or 2x2x4? Sample size for scABE in SAS? Re-inventing the wheel RTR\|TRT 3x3 or 2x4?	felipeberlinski	2014-10-22 14:20	10	2015-04-08 14:19	16,220
Statistical Analysis section of partial replicate BE study Subjects to be considered in partial replicate BE study Subjects to be considered in partial replicate BE study Subjects to be considered in partial replicate BE study Subjects to be considered in partial replicate BE study Subjects to be considered in partial replicate BE study Subjects to be considered in partial replicate BE study Subjects in replicate BE study EU/FDA Subjects in replicate BE study EU/FDA Subjects in replicate BE study EU/FDA Subjects in replicate BE study EU/FDA Subjects in replicate BE study EU Subjects to be considered in partial replicate BE study Subjects to be considered in partial replicate BE study Subjects to be considered in partial replicate BE study Subjects to be considered in partial replicate BE study Subjects to be considered in partial replicate BE study NCA with bear? Bear and null PK parameters to exclude or not to exclude the subjects with bear? to exclude or not to exclude - let the user decide to exclude or not to exclude - let the user decide to exclude or not to exclude - let the user decide to exclude or not to exclude - let the user decide Constraints, algebra, jommetry and such Constraints, algebra, jommetry and such Constraints, algebra, jommetry and such Constraints, algebra, jommetry and such Proc GLM, lm() do not auto-exclude subjects Proc GLM, lm() do not auto-exclude subjects	cher0424	2015-01-07 06:39	29	2015-04-01 14:29	32,571
EMA oracle EMA oracle Personal opinion EMA oracle EMA oracle EMA oracle Response from Alfredo García-Arieta Response from Alfredo García-Arieta Wonnemann’s Figure 4 on steroids Wonnemann’s Figure 4 on steroids Wonnemann’s Figure 4 on steroids General remarks General remarks General remarks General remarks General remarks TIE: questions TIE: questions FDA RSABE & alpha inflation FDA RSABE & alpha inflation FDA RSABE & alpha inflation FDA RSABE & alpha inflation New Zealand New Zealand New Zealand New Zealand New Zealand	Helmut	2015-01-27 16:27	26	2015-02-03 12:41	25,344
Partial Replicate with Groups Partial Replicate with Groups	MGR	2015-02-03 09:46	1	2015-02-03 09:54	4,163
pilot replicate design pilot replicate design pilot replicate design N=24?? pilot replicate design pilot replicate design Futile… new information kinetica kinetica	khaoula	2014-11-19 12:00	9	2014-11-22 11:43	10,472
Case Study (FDA) Case Study (FDA) Case Study (FDA) Case Study (FDA) Case Study (FDA) Case Study (FDA) Case Study (FDA)	Helmut	2014-09-30 13:02	6	2014-10-01 18:41	9,794
EMA: α-inflation – the suspicion begins to mount EMA: α-inflation – the suspicion begins to mount Why simulate a simple AB\|BA at all? Why simulate a simple AB\|BA at all? Fancy smoothing? Arbitrary smoothing? Noise… TSD Japonica… TSD Japonica… Noise debugged Noise debugged Shit happens Commentary Commentary Commentary IBE/PBE = Two-Stage IBE/PBE = Two-Stage Sequential Design = Inflation likely…	Helmut	2014-07-21 02:04	17	2014-09-30 13:03	14,620
difficulty of understanding HVDPs difficult to mee too HVDs ≠ HVDPs HVDs ≠ HVDPs	khaoula	2014-09-08 15:01	3	2014-09-13 17:44	5,144
Model bioequivalence data summary tables-FDA FDA: 90% CI for RSABE FDA: 90% CI for RSABE FDA: 90% CI for RSABE Not cast in stone Not cast in stone Not cast in stone	kumarnaidu	2014-08-20 07:04	6	2014-08-23 04:21	9,444
HVDP RSABE (FDA) and ABEL (EMA) HVDP RSABE (FDA) and ABEL (EMA) HVDP RSABE (FDA) and ABEL (EMA) Some hints Some hints Maths dummy Some hints	khaoula	2014-05-20 19:18	6	2014-05-23 21:44	6,909
Zero concentrations – all samples – full replicate Zero concentrations – all samples – full replicate Zero concentrations – all samples – full replicate serious risk to public health Zero concentrations – all samples – full replicate Zero concentrations – all samples – full replicate Zero concentrations – all samples – full replicate Imputation and BE/TE Zero concentrations – all samples – full replicate Zero concentrations – all samples – full replicate Zero concentrations – all samples – full replicate Zero concentrations – all samples – full replicate Zero concentrations – all samples – full replicate Stability ? Stability ? Stability ? Stability ? Stability ?	pash413	2014-04-05 14:56	17	2014-04-09 14:31	15,056
Reference-scaled Bioequivalence scABE - implied limits	AngusMcLean	2014-03-28 17:48	1	2014-03-31 09:16	3,973
Narrow therapeutic index drug FDA: NTID-RSABE	Mahesh M	2014-01-02 10:32	1	2014-01-02 12:20	6,617
Partial replicate design extra-reference design	Silva	2013-12-31 12:17	1	2013-12-31 13:28	4,847
tada: Another issue with FDA's RSABE (please confirm?) Phoenix/WinNonlin: not confirmed Phoenix/WinNonlin: not confirmed TRT\|RTR or FA0(1) TRT\|RTR or FA0(1) Partial replicate crap? Really? Partial replicate crap? Really? Tweak & Fiddle Tweak & Fiddle Not confirmed - SAS	jag009	2013-12-19 17:41	9	2013-12-23 13:06	9,345