Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
Sample Size Estimation in Bioequivalence 💯☑️ 📌 Preliminary evaluation	Surveys	Helmut	2020-05-20 22:39	1	2020-06-03 12:36	2,203
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		115,468
AUCt not covering at least 80% of AUCinf AUCt not covering at least 80% of AUCinf AUCt not covering at least 80% of AUCinf AUCt not covering at least 80% of AUCinf ADME-tox? ADME-tox? OT OT OT Science vs. regulations Science vs. regulations ratio = difference of logs! Science vs. (EMA) GL aka PK primer Science vs. regulations Science vs. regulations Science vs. regulations Science vs. regulations AUCt not covering at least 80% of AUCinf AUCt not covering at least 80% of AUCinf So what? Carrot and whip	Regulatives / Guidelines	ratnakar1811	2013-03-05 08:30	20	2020-06-06 21:11	17,562
BE study in China (for China) BE study in China (for China) BE study in China (for China)	Regulatives / Guidelines	jag009	2020-06-04 17:50	2	2020-06-05 18:41	116
TDDS non-inferiority analysis	General Statistics	SaraCHenriques	2020-06-01 20:24	0		121
Regarding used normal Two-way crossover program was used for un-scaled average (2×2×2?) ANOVA instead of mixed model	Study Assessment	Sivakrishna	2020-06-01 11:47	1	2020-06-01 15:08	134
Bioequivalence for Parenteral Products T = EV ∧ R = IV ¬ BE (→ absolute BA)	Regulatives / Guidelines	arailkar	2020-05-29 17:21	1	2020-05-29 17:51	142
Simulations 101 Simulations 101 Simulations 101 Simulations 101 More about the tables	Power / Sample Size	Helmut	2020-05-26 23:47	4	2020-05-29 13:30	508
PK study in infants	Regulatives / Guidelines	jag009	2020-05-28 21:18	0		92
NTI Drug	Regulatives / Guidelines	jag009	2020-05-28 21:14	0		90
An example of IS response. Need your helps. An example of IS response. Need your helps. An example of IS response. Need your helps. An example of IS response. Need your helps. An example of IS response. Need your helps. Placement of CC An example of IS response. An example of IS response. Placement of CC Placement of CC Duplicate LLOQ and ULOQ Duplicate LLOQ and ULOQ An example of IS response. Need your helps.	Bioanalytics	Shuanghe	2020-05-26 12:56	12	2020-05-27 16:30	921
ANVISA Regulation for NTI ANVISA Regulation for NTI	Regulatives / Guidelines	Sukalpa Biswas	2020-05-26 12:47	1	2020-05-26 13:39	126
link to Chinese BE-Guideline link to Chinese BE-Guideline link to Chinese BE-Guideline	Regulatives / Guidelines	Dr_Dan	2020-05-25 13:22	2	2020-05-26 11:49	174
Inclusion criteria in BE studies BE: ♀♂ Inclusion criteria in BE studies Stratify for sex? Stratify for sex? Inclusion criteria in BE studies	Design Issues	Loky do	2020-05-22 18:16	5	2020-05-25 21:10	441
Problems with PASS Problems with PASS Problems with PASS Problems with PASS Problems with PASS Problems with PASS PASS <2000? PASS 2020 PASS 2020! PASS 2020: Outcome Customer satisfaction	Software	Helmut	2020-05-15 12:31	10	2020-05-24 22:12	1,589