Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
MR generic application MR generic application MR generic application MR generic application	Mikkabel	2020-03-16 16:40	3	2020-03-27 20:20	6,340
RLD batch number in fed and fast studies RLD batch number in fed and fast studies	Rana jaouni	2020-03-18 20:37	1	2020-03-18 19:46	5,660
What is meant by data amenable?	GM	2020-03-16 12:59	0		3,815
Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Study planning 101 Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Not enough subjects to say Not enough subjects to say Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic	ping4santosh	2020-03-11 14:35	13	2020-03-16 08:13	10,931
Bioequivalence Study without approved/marketed or no RLD Bioequivalence Study without approved/marketed or no RLD BE wo local originator	Pharma_88	2020-03-13 08:37	2	2020-03-13 09:51	5,722
Immediate release fixed dose combination product Immediate release fixed dose combination product Immediate release fixed dose combination product Immediate release fixed dose combination product Immediate release fixed dose combination product Immediate release fixed dose combination product Immediate release fixed dose combination product Immediate release fixed dose combination product Immediate release fixed dose combination product Immediate release fixed dose combination product New product New product New product New product Immediate release fixed dose combination product	ping4santosh	2020-03-06 09:21	14	2020-03-11 19:52	10,525
Test samples expired for FED study Test samples expired for FED study Test samples expired for FED study Different batches Different batches Different batches Different batches The soft-spoken voice of reason Different batches Different batches Test samples expired for FED study Test samples expired for FED study	taiyab.jameel	2020-03-05 10:02	11	2020-03-11 10:39	9,825
Pediatric study for a combination product Pediatric study for a combination product	jag009	2020-02-20 19:59	1	2020-03-03 14:53	3,682
Meals in fast and fed studies Meals in fast and fed studies	Ayman Rabayah	2020-03-03 08:48	1	2020-03-03 14:35	3,977
Non-aqueous solutions	The Outlaw Torn	2020-02-24 08:58	0		2,253
Orange or citrus flavor Orange or citrus flavor Orange or citrus flavor Orange or citrus flavor	Dr_Dan	2020-02-20 09:01	3	2020-02-20 11:24	4,326
Definition of estimands in PK studies Definition of estimands in PK studies Paper behind a pay wall	martin	2018-03-18 21:26	2	2020-02-19 10:44	5,870
clinicaltrials registration clinicaltrials registration clinicaltrials registration	powell	2020-02-10 05:36	2	2020-02-13 09:00	4,139
EMA: What do I need if I want to run an overdose study EMA: What do I need if I want to run an overdose study EMA: What do I need if I want to run an overdose study Can of worms Can of worms Can of worms Can of worms EMA: What do I need if I want to run an overdose study EMA: What do I need if I want to run an overdose study	jag009	2020-01-28 20:12	8	2020-02-03 19:34	8,504
FDA: required BE between early phase and Phase 3 formulations? no BE between early phase and Phase 3 formulations no BE between early phase and Phase 3 formulations relax Thanks! FDA: required BE between early phase and Phase 3 formulations?	fno	2020-01-22 15:38	5	2020-01-27 19:06	6,614