Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
Sample Size Based on Pharmacodynamic endpoints Sample Size Based on Pharmacodynamic endpoints Sample Size Based on Pharmacodynamic endpoints Sample Size Based on Pharmacodynamic endpoints Sample Size Based on Pharmacodynamic endpoints Sample Size Based on Pharmacodynamic endpoints	Power / Sample Size	sury	2019-04-03 12:28	5	2019-04-05 08:37	370
Possible bug in bootf2BCA Bug in bootf2BCA - Open source rulez!	Software	Shuanghe	2019-04-03 17:41	1	2019-04-03 19:42	271
Carry-over in pre-dose samples for steady state BE Carry-over in pre-dose samples for steady state BE 5% Cmax-rule only in SD 5% Cmax-rule only in SD Carry-over in pre-dose samples for steady state BE	Study Assessment	hirenpharm	2019-03-29 20:56	4	2019-04-03 02:48	417
Pharmacokinetic Solidarity? Pharmacokinetic Solidarity? Pharmacokinetic Solidarity? Pharmacokinetic Solidarity?	BE/BA News	mittyri	2019-04-02 12:32	3	2019-04-02 13:37	327
News from EMA: Pharmacokinetic Solidarity	BE/BA News	EMA.Press.Office	2019-04-01 00:07	0		404
Finally: Exact TSD methods for 2×2 crossover designs Exact TSD methods: Example Finally: Exact TSD methods for 2×2 crossover designs Flow chart (without details) naive questions regarding new functions in Power2Stage Some answers Some more "answers" clarification regarding user Power2Stage guides Technicality: Weigths for the inverse normal approach Selection of w and w* Selection of w and w* Now what? w & w* examples Now what? w & w* examples Now what? w & w* examples Now what? w & w* examples a bug in interim.tsd.in()? a bug in interim.tsd.in()? Nonbinding futility rule Bad weather? NLYW? Nonbinding futility rule Nonbinding futility rule Nonbinding futility rule Binding / Nonbinding futility rule - alpha control Binding / Nonbinding futility rule - alpha control	Two-Stage / GS Designs	Helmut	2018-04-21 17:17	24	2019-03-30 09:52	5,695
importance of bioanalytical validation importance of bioanalytical validation OT: Your signature OT: Correct as often OT: Nerds chatting OT: Nerds chatting OT: Nerds chatting OT: Nerds chatting OT: Nerds chatting OT: Nerds chatting OT: Nerds chatting OT: Nerds chatting	Bioanalytics	averroes1304	2019-03-27 11:55	11	2019-03-28 13:59	554
Appropriate matrix (heparinized plasma, EDTA plasma or serum) Appropriate matrix (heparinized plasma, EDTA plasma or serum)	Bioanalytics	hershey	2019-03-27 09:35	1	2019-03-27 10:05	229
FDA Form 1572 FDA Form 1572	Regulatives / Guidelines	rajasekharkakarla	2019-03-27 07:48	1	2019-03-27 09:56	272
Training of SOPs Training of SOPs Training of SOPs Training of SOPs	GxP / QC / QA	Pandu	2019-03-25 11:16	3	2019-03-27 08:14	305
CDISC datasets or R. Acceptable ?? CDISC datasets from R. Why not? CDISC datasets from R. Why not? CDISC datasets from R. Why not? CDISC datasets from R. Why not? Some code Some code SAS only? SAS only? Confusing… Confusing…	Software	WhiteCoatWriter	2019-03-21 07:13	10	2019-03-27 06:55	674
Three-way crossover BABE Studies Three-way crossover example data set Three-way crossover example data set Three-way crossover example data set Three-way crossover (WinNonlin) Three-way crossover (WinNonlin) Three-way crossover (WinNonlin) Three-way crossover (WinNonlin) Three-way crossover example data set Three-way crossover example data set Three-way crossover example data set Three-way crossover example data set Leave-One-Out (IBD) Leave-One-Out (IBD) Impact of pooled variance (bias, CI) carry (over?) Pseudo-periods Pseudo-periods Two‐at‐a‐Time analysis in R fixed & mixed (dammit!) and a request to SASians Pooled vs IBD T-R in SAS from non-SASian Pooled vs IBD T-R in SAS from non-SASian mixed in R mixed in R (EMA B ≠ FDA)	Design Issues	acfalcao	2007-09-16 22:34	23	2019-03-24 01:23	14,603
Update R and its libraries Update R and its libraries Update R and its libraries	R for BE/BA	Helmut	2019-03-23 18:20	2	2019-03-23 23:46	233
Deletti tables for sample size Of historic(al) interest only Of historic(al) interest only Software validation – again and again Software validation – again and again Fiaker und Apfelstrudel Fiaker und Apfelstrudel Fiaker und Apfelstrudel Fiaker und Apfelstrudel Fiaker und Apfelstrudel White-box validation White-box validation Power of Proc Power	Power / Sample Size	sury	2019-03-19 12:22	12	2019-03-21 00:19	616
Handling BLOQ values (Fisher Info etc.) Handling BLOQ values (Fisher Info etc.) The smartest solution An old solution old, obvious? Example ADA example My beloved Ada Handling BLOQ values (Fisher Info etc.) Handling BLOQ values (Fisher Info etc.) Don’t weight by 1/s²	Bioanalytics	mittyri	2019-03-16 14:41	10	2019-03-19 08:26	611