Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
steep exposure-response relationship steep exposure-response relationship steep exposure-response relationship	Mahesh M	2015-10-27 07:01	2	2015-10-27 09:51	8,068
Generic application Generic application: submission to multiple authorities	bkrao	2015-10-16 08:15	1	2015-10-16 09:47	4,393
Audio video recording of informed consent Audio video recording of informed consent Audio video recording of informed consent	Ohlbe	2015-08-20 18:03	2	2015-10-14 10:19	7,840
MHRA regulatory issue	Melkor	2015-10-11 19:49	0		2,965
Extent of Protocol deviation accepted by the Agency Ethics? Ethics?	bharathi	2014-09-16 12:19	2	2015-10-01 04:57	5,565
Metformin FDC Metformin FDC	MaggieSantos	2015-09-25 19:39	1	2015-09-28 14:52	4,676
New D. Guidance – Dabigatran New D. Guidance – Dabigatran The FDA’s fourth BE approach! The FDA’s fourth BE approach! The FDA’s fourth BE approach! The FDA’s fourth BE approach! Yada Yada Yada Yucky… The FDA’s fourth BE approach! New PowerTOST function(s) New PowerTOST function(s) Pradaxa = HVDP (dabigatran = HVD?) Pradaxa = HVDP (dabigatran = HVD?) HVNTID's HVNTID's Highly variable NTID What a mess! Messy numbers - PowerTOST V1.3-01 preview What a mess! OT: power.NTIDFDA() OT: power.NTIDFDA()	jag009	2015-09-21 23:19	19	2015-09-25 14:32	22,319
Study Protocol guidance (esp. PD)	bkrao	2015-09-23 11:53	0		2,491
Delegation of Duties by PI in BA/BE studies Delegation of Duties by PI in BA/BE studies Delegation of Duties by PI in BA/BE studies Delegation of Duties by PI in BA/BE studies Delegation of Duties by PI in BA/BE studies	ratnakar1811	2015-09-22 09:14	4	2015-09-23 06:59	6,268
In-vitro Dissolution complementary to BE In-vitro Dissolution complementary to BE In-vitro Dissolution complementary to BE In-vitro Dissolution: Order and questions In-vitro Dissolution: Order and questions In-vitro Dissolution: Order and questions In vivo ≫ in vitro In vivo ≫ in vitro In vivo ≫ in vitro In vivo ≫ in vitro What about BCS II, (III), IV?	sireen	2013-12-14 12:27	10	2015-09-18 10:25	12,701
FDA: Hydrocortisone FDA: Hydrocortisone FDA: Hydrocortisone	Mahesh M	2015-09-15 08:03	2	2015-09-16 04:50	4,497
Zimbabwe Regulatory Zimbabwe Regulatory Sub-Saharan Africa Sub-Saharan Africa Sub-Saharan Africa Sub-Saharan Africa	bkrao	2015-09-02 13:24	5	2015-09-10 11:19	6,682
Partial Validation Partial Validation	chowdary123	2015-09-03 13:29	1	2015-09-04 08:32	4,289
impact analysis	Mitesh Panchal	2015-08-30 20:19	0		2,735
Bio-batch size for suspensions	sireen	2015-08-24 05:20	0		3,193