Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
multiple dose bioequivalence study EMA MR: long half life → MD EMA MR: long half life → MD multiple dose bioequivalence study	Loky do	2020-08-09 11:50	3	2020-08-10 06:00	3,952
Difference between BABE study and clinical trials Difference between BABE study and clinical trials BABE ∈ Phase I Difference between BABE study and clinical trials Difference between BABE study and clinical trials	VijithRoy	2020-07-30 15:15	4	2020-07-31 11:52	7,451
Sequence assignments in partially replicate design Sequence codes irrelevant Sequence codes irrelevant 3-period full replicates 3-period full replicates	Loky do	2020-07-19 01:33	4	2020-07-22 08:17	3,831
Design of Bi-layer products EMA: FDC products (lenghty post) EMA: FDC products (lenghty post)	A.Shtaiwi	2020-07-17 12:51	2	2020-07-19 13:13	4,493
No RLD product	Sriramprasad	2020-07-18 07:21	0		1,856
Torasemide BE Study EU	pmohite	2020-06-22 11:25	0		2,567
Two-stage BE study Two-stage BE study	Achievwin	2020-06-17 15:12	1	2020-06-18 05:06	3,081
How to analyze bioavailable of single arm data comparing a historical control Dazed and confused Bridging study?	libaiyi	2020-06-09 07:48	2	2020-06-11 16:27	2,955
Randomization for Replicate design studies Randomization for Replicate design studies Randomization for Replicate design studies	mmw	2020-04-18 13:43	2	2020-04-28 07:27	5,376
long acting Injection long acting Injection long acting Injection	pankajsojitra	2020-04-19 11:15	2	2020-04-23 12:40	4,503
Steady State Bioequivalence Study Pre-dose samples Study design multiple dose stuy - circadian PK	Pharma_88	2020-01-08 10:07	2	2020-03-26 16:29	6,549
NTI drugs and Full Replicate FDA: 2×2×4 design; RSABE + ABE + σwT/σwR FDA: 2×2×4 design; RSABE + ABE + σwT/σwR FDA: NTID and “HVNTID”	Pharma_88	2020-03-10 06:39	3	2020-03-13 09:35	7,626
Fast & fed studies Fast & fed studies Fast & fed studies Fast & fed in one study (alternative) Fast & fed in one study (alternative) Fast & fed in one study (alternative) Fast & fed in one study (alternative) Fast & fed in one study (alternative) Fast & fed in one study (alternative)	Amira Gouda	2020-03-01 20:28	8	2020-03-06 12:35	6,273
Study which captures SD and SS PK Profiles A vs B A vs B ANDA or NDA? Modelling Modelling Modelling: SD+SS	jag009	2020-02-03 20:15	6	2020-02-04 11:38	5,344
3+3 Design 3+3 Design 3+3 Design Subject replacement Dose escalation and DMC Dose escalation and DMC	Pharma_88	2020-01-07 08:09	5	2020-01-08 09:41	5,456