Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	R’s	last reply	V’s
Incurred sample reanalysis Incurred sample reanalysis Incurred sample reanalysis	Regulatives / Guidelines	sushil.pimpare	2017-06-06 07:53	2	2017-06-06 12:10	401
Potvin C in the EU Potvin C in the EU Potvin C in the EU 2 Groups model FDA 2 Groups model FDA Group effects obsolete? Group effects FDA/EMA Group effects FDA/EMA Group effects FDA/EMA Group effects EMA Group effects EMA Group effects EMA Group effects EMA Group effects EMA Group effects EMA Fixed effects model with Group term Fixed effects model: changing the F, p values Fixed effects model: changing the F, p values Fixed effects model: changing the F, p values Holy War of type III Significance of Group effect in Russia: why the type III is so 'important' Fixed effects model: changing the F, p values FDA group model in R FDA group model in R FDA group model in R FDA group model in R FDA group model in R Fixed effects model with Group term Group effects FDA/EMA Group effects FDA/EMA 2 Groups model FDA Homework	Two-Stage / GS Designs	Helmut	2013-04-16 17:40	31	2017-06-03 14:57	13,842
Assumptions for powering a XO study CVintra ≠ CVtotal	Power / Sample Size	Laura R	2017-06-01 14:57	1	2017-06-01 15:47	441
change in CC range exact matching of CCs (validation’s and study’s) exact matching of CCs (validation’s and study’s) exact matching of CCs (validation’s and study’s) exact matching of CCs (validation’s and study’s) exact matching of CCs (validation’s and study’s) exact matching of CCs (validation’s and study’s) Sapere aude!	Regulatives / Guidelines	sushil.pimpare	2017-05-31 09:31	7	2017-05-31 15:38	557
PC PP domains for CDISC submission PC PP domains for CDISC submission	Regulatives / Guidelines	Abc123	2017-05-29 12:45	1	2017-05-30 11:19	411
Analysis of data of partial replicate design (2x3x3) in bear2.8.3 partial replicate design (2x3x3) in bear	R for BE/BA	mahmoud-teaima	2017-05-29 14:02	1	2017-05-29 18:15	454
Biowaiver salt vs. cocrystal Biowaiver salt vs. cocrystal Biowaiver salt vs. cocrystal Biowaiver salt vs. cocrystal	Dissolution / BCS / IVIVC	Dr_Dan	2017-05-24 18:56	3	2017-05-29 10:15	608
Why to dose 2 tablets of 200 mg tablets of Amiodarone in BE studies	Design Issues	KK	2017-05-26 11:09	0		315
Russian «Экспертами» and their hobby Low power of Group-by-Treatment interaction Let’s forget the Group-by-Treatment interaction, please! Let’s forget the Group-by-Treatment interaction, please! Some answers Some answers Example Sensitivity of term? Simulations loosing specificity due to low sensitivity loosing specificity due to low sensitivity Loss in power Interval between groups IMP handling IMP handling Loss in power No convergence in JMP and Phoenix WinNonlin Ouch?!??? Russian «Экспертами» and their hobby be careful with mixed models be careful with mixed models p-value(s) in model 2 Russian «Экспертами» following the EEU GLs Russian «Экспертами» following the EEU GLs Penalty for carelessness Russian «Экспертами» following the EEU GLs	General Statistics	Helmut	2017-04-29 00:46	25	2017-05-25 16:24	2,613
AUC calculation in bear lin-up/log-down is bear’s default lin-up/log-down any regulatory recommendation? lin-up/log-down any regulatory recommendation? lin-up/log-down any regulatory recommendation? lin-up/log-down is bear’s default lin-up/log-down is bear’s default zero (0), missing (NA), or BLLOQ (0 or NA) in bear (II) zero (0), missing (NA), or BLLOQ (0 or NA) in bear (II) lin-up/log-down is bear’s default Never use Excel	R for BE/BA	pjs	2017-05-21 15:57	10	2017-05-25 15:17	803
Whistleblowers, stand up! Whistleblowers, stand up! Whistleblowers, stand up! This isn't about whistleblowers This isn't about whistleblowers This isn't about whistleblowers	BE/BA News	Helmut	2017-05-23 14:12	5	2017-05-25 12:37	706
rl.gui in bear2.8.2 it's totally my fault it's totally my fault	R for BE/BA	mahmoud-teaima	2017-05-23 16:49	2	2017-05-25 01:54	458
More samples – less variability (for Cmax)? More samples – less variability (for Cmax) Sample volume Sample volume Sample volume More samples – less variability (for Cmax)	Design Issues	nobody	2017-05-23 09:07	5	2017-05-23 19:00	579
Sample Size calculation and setting of BE limit base on Cmax or AUC PK metric with largest variability – generally – drives the sample size Regulatory guidance versus literature data FDA: If RSABE not recommended in product-specific guidance FDA: If RSABE not recommended in product-specific guidance	Power / Sample Size	mahmoud-teaima	2017-05-22 13:55	4	2017-05-23 16:20	569
Recipe for ABEL and adjusted α Recipe for ABEL and adjusted α PowerTOST V1.4-5 - scABEL functions	RSABE / ABEL	Helmut	2017-03-23 19:10	2	2017-05-23 10:25	851
Study Results Study Results upper CL < PE PE restriction for HVDs/HVDPs; testing effects PE restriction for HVDs/HVDPs; testing effects PE restriction for HVDs/HVDPs; testing effects PE restriction for HVDs/HVDPs; testing effects PE restriction for HVDs/HVDPs GMR outside the limits when using ABEL Regulations ≠ Science Regulations ≠ Science	Study Assessment	VSL	2015-04-20 21:46	10	2017-05-22 20:51	6,345