Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
BE studies requirements BE studies requirements BE studies requirements BE studies with clinical endpoints-study population Homework	satishpsm	2014-11-05 09:29	4	2014-11-07 14:31	4,602
BE NOC Regulatory Check list for BE NOC Regulatory Check list for BE NOC Regulatory Check list for	rsr	2014-11-03 06:07	2	2014-11-03 08:47	3,891
Incurred sample reanalysis Incurred sample reanalysis Incurred sample reanalysis Clopidogrel Clopidogrel Lack of ISR / only 5% ISR in study with 656 samples Lack of ISR / only 5% ISR in study with 656 samples Lack of ISR / only 5% ISR in study with 656 samples "Meth" - apologies "Meth" - apologies "Meth" - apologies "ISR" - apologies Repeat use Repeat use Repeat use "ISR" – resolved "ISR" – resolved Lack of ISR / only 5% ISR in study with 656 samples Some more stuff Lack of ISR / only 5% ISR in study with 656 samples	sarada06884	2013-04-09 12:22	19	2014-10-23 08:06	19,085
Dispersible Tablets Dispersible Tablets	Ahmed Al Habashi	2014-10-20 12:10	1	2014-10-23 07:31	3,301
Validity of BE No “shelf life”, but… Validity of BE	wien-ui	2014-10-22 19:02	2	2014-10-23 07:24	3,732
ODF (Oral Dispersible Films)-BE ODF (Oral Dispersible Films)-BE	Ahmed Al Habashi	2014-10-20 12:09	1	2014-10-20 11:08	3,396
Desmopressin Acetate RLD confirmation USFDA Desmopressin Acetate RLD confirmation USFDA We are not hearing &\| visually impaired	Anand	2014-10-17 06:34	2	2014-10-17 14:47	3,573
Therapeutic Code; None in USFDA Therapeutic Code; None in USFDA	Anand	2014-10-17 06:29	1	2014-10-17 13:57	3,710
Test Product Shape & Colour Changes in Europe	Anand	2014-10-17 06:24	0		1,844
Current BE guideline India? Current BE guideline India? Confirmation pending Confirmation pending Terrible… Terrible…	nobody	2014-10-14 11:44	5	2014-10-16 19:31	4,596
Tablet Scoring: A must for Generic Companies? Tablet Scoring: A must for Generic Companies?	luvblooms	2014-10-14 10:52	1	2014-10-14 14:54	2,963
Teriminal partial AUC for Metformin ER Tablets Teriminal partial AUC for Metformin ER Tablets Teriminal partial AUC for Metformin ER Tablets Teriminal partial AUC for Metformin ER Tablets Epilim Chrono 500 CR tablets	Naveen Kumar	2014-09-10 12:34	4	2014-10-13 10:39	4,796
Rechallenge (or re-dosing) study Rechallenge (or re-dosing) study Rechallenge (or re-dosing) study Rechallenge (or re-dosing) study	jag009	2014-10-01 20:53	3	2014-10-09 04:10	4,163
BE study for Egypt submission	Debbie	2014-09-29 12:47	0		1,805
Phenytoin BE Limits Phenytoin BE Limits The other way around? Narrowing, widening and typos Narrowing, widening and typos Narrowing, widening and typos Narrowing, widening and typos FDA: phenytoin = NTID? FDA: phenytoin = NTID? AUC more critical? AUC more critical? Narrowing, widening and typos Narrowing, widening and typos	prashantmohite	2014-09-11 15:20	12	2014-09-26 12:17	6,796