Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Significant difference in Cmax of Reference drug product Significant difference in Cmax of Reference drug product Significant difference in Cmax of Reference drug product Different products → different BA Significant difference in Cmax of Reference drug product Reasons? Reasons?	Mehul Patel	2021-08-17 10:00	6	2021-08-24 10:06	2,683
Confidence interval between two study for same test and reference lot Different PE in repeated study Confidence interval between two study for same test and reference lot	RahulG628	2021-08-04 17:40	2	2021-08-04 19:41	2,760
Fully Replicate Study Outliers in study intended for RSABE Outliers in study intended for RSABE failed study? Failed study Failed study	NK	2021-04-26 09:46	5	2021-04-26 22:33	2,969
Bioequivalence study of Glimepride Tablet Reformulate… Reformulate…	Ibrahim Komeil	2021-02-15 10:07	2	2021-02-15 22:48	1,727
Deficiencies ?? Deficiencies ?? Deficiencies ?? Deficiencies ?? Deficiencies or not Deficiencies or not	Helmut	2021-01-26 10:47	5	2021-01-31 14:46	2,818
Data manipulation / fraud in BE	ElMaestro	2020-10-21 09:56	0		1,708
Subject non compliance Subject non compliance (or product failure?) Subject non compliance (or product failure?) Bad science (statistics is taboo) unexpected behavior for test product Subject-by-Formulation interaction? Subject-by-Formulation interaction?	Loky do	2020-07-15 12:57	6	2020-07-26 09:30	2,844
Missing concentration Missing concentration	shahajan baig	2020-07-06 01:15	1	2020-07-13 11:51	2,186
Regarding used normal Two-way crossover program was used for un-scaled average (2×2×2?) ANOVA instead of mixed model	Sivakrishna	2020-06-01 11:47	1	2020-06-01 13:08	1,970
Outlier in BE study Outlier in BE study Outlier in BE study Outlier in BE study Missing samples Missing samples Missing samples Missing samples Options Options	Amira Gouda	2020-04-28 15:36	9	2020-05-03 19:15	6,496
Meets primary objective but not secondary objective Meets primary objective but not secondary objective Meets primary objective but not secondary objective Meets primary objective but not secondary objective Meets primary objective but not secondary objective	Brus	2020-03-27 17:22	4	2020-04-06 17:41	2,824
The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time	wienui	2020-01-05 18:22	5	2020-01-28 19:16	5,450
BEQ inquiry from health authority BEQ inquiry from health authority Method not sensitive enough Revalidation? Revalidation? Method not sensitive enough Method not sensitive enough Method not sensitive enough	Aymanmy	2019-12-18 08:51	7	2019-12-19 07:21	4,216
Impact of Parenteral hydration in a BE study Violation of GCP‽ Impact of Parenteral hydration in a BE study Impact of Parenteral hydration in a BE study	Cec75	2019-11-15 16:39	3	2019-11-19 15:03	3,559
NTI drug Bioequivalence study Statistical approach Cherry-picking? digging out the possible reasons of the failure Fed state: T higher variable than R	Sukalpa Biswas	2019-08-06 09:15	3	2019-08-09 10:36	4,902