Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Handling large Extrapolated AUC Values residual area < 20% for more than 80% subjects residual area < 20% for more than 80% subjects Exclusion for the FDA?	Sereng	2022-05-12 17:17	3	2022-05-23 09:43	4,989
Bioequivalence study of sertraline HCL capsule Do your homework first	Vishal S	2022-05-16 14:40	1	2022-05-16 13:48	4,302
BE Confidence Interval Criteria: AUC(t) or AUC(inf) or both? BE Confidence Interval Criteria: AUC(t) or AUC(inf) or both?	Sereng	2022-05-12 17:14	1	2022-05-12 20:14	3,847
ICH guideline M10 on BA method validation Stock solutions for CCs and QCs ICH guideline M10 on BA method validation	PSU	2022-05-03 15:53	2	2022-05-05 09:47	4,679
BE study for China	jag009	2022-04-14 19:06	0		3,102
Bioequivalence studies at night Bioequivalence studies at night	Loky do	2022-03-28 12:36	1	2022-03-28 12:23	4,519
Kel Calculation in ANVISA Regulatory Data, please ANVISA’s strange examples R2adj improvement limit R2adj improvement limit	MGR	2022-03-21 07:30	4	2022-03-22 13:04	9,092
Potvin method is acceptable or not for FDA Potvin method is acceptable or not for FDA Simulation-based methods acceptable for the FDA	khageswara Rao	2022-03-21 12:10	2	2022-03-21 12:32	4,328
Corrections for Potency Typos… Typos… Typos… Typos… Typos… Wrong formula for CV	Shatha	2022-03-20 14:51	6	2022-03-21 09:02	5,587
Females in Bioequivalence studies Females in Bioequivalence studies	Loky do	2022-03-08 15:36	1	2022-03-08 19:09	4,049
Gender effect on metformin and sitagliptin Gender effect on metformin and sitagliptin Gender effect on metformin and sitagliptin	khageswara Rao	2022-03-01 07:26	2	2022-03-03 04:54	4,281
biowaiver for higher strength biowaiver for higher strength biowaiver for higher strength biowaiver for higher strength biowaiver for higher strength Linearity Linearity biowaiver for higher strength	jag009	2022-01-24 07:48	7	2022-02-03 18:07	6,998
BMI Criteria for FDA BMI Criteria for FDA BMI Criteria for FDA	khageswara Rao	2022-01-25 06:43	2	2022-02-03 09:47	4,517
IMP Retention samples for Brazil BA BE studies	nlpati	2022-02-01 05:44	0		12,549
Invitro microbial kill rate Stat analysis Invitro microbial kill rate Stat analysis Invitro microbial kill rate Stat analysis Invitro microbial kill rate Stat analysis	MGR	2021-12-15 06:51	3	2021-12-20 11:17	4,689