Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
▼ Read before registering ▼	Tips / Tricks	Helmut	2016-04-14 23:39	0		36,474
BCS Based Biowaiver application Price?	Dissolution / BCS / IVIVC	joosefupas	2018-10-19 14:54	0		160
Quality System	GxP / QC / QA	vishal1721	2018-10-19 09:29	0		132
Little thing which changes almost everything in EEU LLOQ ≤5% of expected or observed Cmax? LLOQ ≤5% of average or minimal Cmax? LLOQ ≤5% of individual Cmax-values LLOQ ≤5% of individual Cmax-values An outlier?	Bioanalytics	Beholder	2018-10-18 09:08	5	2018-10-19 09:43	300
Theophylline ER 450 mg study design	Design Issues	Ramesh Ramalingam	2018-10-18 07:16	0		113
Reference drug product for Captopril / Hydrochlorothiazide	Design Issues	A-M-R	2018-10-17 14:46	0		102
Product-specific advice (steroid nasal sprays) Product-specific advice (steroid nasal sprays) Product-specific advice (steroid nasal sprays) Product-specific advice (steroid nasal sprays)	Design Issues	Mikalai	2018-10-16 13:42	3	2018-10-17 11:56	213
All animals are equal, but some animals are more equal than others	BE/BA News	Helmut	2018-10-09 14:33	0		230
Redesign of the EMA’s website	BE/BA News	Helmut	2018-10-08 12:20	0		248
Enoxaparin sodium injection BA BE studies BE of parenterals Enoxaparin sodium injection BA BE studies Enoxaparin sodium injection BA BE studies Enoxaparin sodium injection BA BE studies Enoxaparin sodium injection BA BE studies	Regulatives / Guidelines	varsha chungde	2018-10-08 11:34	5	2018-10-10 07:11	400
Test License Test License Test License	Regulatives / Guidelines	rajasekharkakarla	2018-10-06 08:05	2	2018-10-07 21:04	274
Retention of BA/BE samples	Regulatives / Guidelines	Neelu Singh	2018-10-05 06:57	0		237
Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion Subject exclusion	Outliers	Mohamed Yehia	2018-10-02 21:25	11	2018-10-03 23:47	642
FDA Recommendation on Matrix Effect Determination in CC Assay FDA Recommendation on Matrix Effect Determination in CC Assay FDA Recommendation on Matrix Effect Determination in CC Assay Reducing matrix effects	Bioanalytics	Obinoscopy	2018-10-01 14:38	3	2018-10-01 17:20	311
Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver	Dissolution / BCS / IVIVC	Amalia	2018-10-01 11:04	10	2018-10-06 19:59	541
Error in bear Error in bear	R for BE/BA	tshianza	2018-09-28 08:16	1	2018-09-28 09:49	315

Bioequivalence and Bioavailability Forum 09:12 CEST