Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Draft Guidance on Budesonide ER Released	kumarnaidu	2014-12-15 11:15	0		2,683
EMA: missing documents EMA: missing documents EMA: missing documents	Helmut	2014-12-11 17:09	2	2014-12-12 15:01	3,397
MDIs formulation MDIs formulation MDIs formulation MDIs formulation	Mahesh M	2014-12-11 13:45	3	2014-12-12 08:36	4,076
Draft FDA guidance on Methylphenidate Hydrochloride Five PK metrics + S×F interaction Five PK metrics + S×F interaction Phoenix Phoenix Phoenix Five PK metrics + S×F interaction Acceptance limit for the upper 95% confidence bound? Acceptance limit for the upper 95% confidence bound? Quoting László Acceptance limit for the upper 95% confidence bound? Five PK metrics + S×F interaction No RSABE No RSABE No RSABE Five PK metrics + S×F interaction Five PK metrics + S×F interaction Five PK metrics + S×F interaction Five PK metrics + S×F interaction Tada! Tada! Tada! Tada! Tada! ABEL ABEL ABEL ABEL ABEL ABEL Difficult formulations Difficult formulations Difficult formulations	kumarnaidu	2014-11-10 08:16	32	2014-12-09 13:50	18,663
REMS Way Forward: FDA New Draft Guidance	luvblooms	2014-12-05 08:20	0		2,448
orally inhaled products (OIPs) orally inhaled products (OIPs) orally inhaled products (OIPs) orally inhaled products (OIPs) orally inhaled products (OIPs)	Mahesh M	2014-12-03 13:10	4	2014-12-04 14:40	4,449
EMA MR guideline Published ! Published ! Published ! In effect 1 June 2015 In effect 1 June 2015 Accumulation Accumulation	Ohlbe	2014-11-18 22:55	7	2014-12-01 14:48	5,251
Bioanalysis Bioanalysis Bioanalysis Stopping for futility Bioanalysis	balakotu	2014-11-28 08:26	4	2014-11-28 13:21	5,370
GL on the PK and clinical evaluation of MR dosage forms	pash413	2014-11-28 13:54	0		2,692
Missing Concentration calculation/estimation Missing Concentration calculation/estimation Missing Concentration calculation/estimation	rams	2014-11-27 14:18	2	2014-11-27 13:53	3,645
Guideline Health Canada Generally no dose-correction Generally no dose-correction	khaoula	2014-11-23 17:35	2	2014-11-23 17:16	4,759
Precision of Analytical Procedure	VSL	2014-11-22 16:00	0		2,218
sublingual tablets sublingual tablets sublingual tablets sublingual tablets	A-M-R	2013-02-04 08:34	3	2014-11-21 10:33	7,015
Subject population to be enrolled Subject population to be enrolled Subject population to be enrolled	pash413	2014-11-10 11:23	2	2014-11-10 17:42	4,708
FDA released guidance on Circumstances that Constitute Delay Refusing an inspection…	drgunasakaran1	2014-11-03 17:18	1	2014-11-09 11:37	4,045