Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
WHO Guidelines draft, April 2014 WHO Guidelines draft, April 2014 Two-Stage Designs interim analysis, wording interim analysis, wording WHO Guidelines draft, April 2014 No Add-on studies	wien-ui	2014-06-11 18:32	6	2014-06-22 12:31	5,899
Smoking in bioequivalence studies Smoking in bioequivalence studies Smoking in bioequivalence studies More information, please	Ghannam86	2014-06-21 01:05	3	2014-06-21 22:22	6,569
Health Canada spcs search Health Canada Health Canada	bharathnadh.pharma	2014-06-16 13:28	2	2014-06-21 07:38	2,891
Archival period for Investgational products	pravin17	2014-06-20 14:15	0		1,667
three consecutive missing samples three consecutive missing samples	Mahesh M	2014-06-18 09:47	1	2014-06-18 14:05	2,548
Draft guidance for industry, entitled ANDA Submissions	suchit_bhavsar	2014-06-13 08:20	0		1,752
Justification of AUC0-72 usage and AP calculation EMA: No justification needed	mittyri	2014-06-10 20:05	1	2014-06-10 19:17	3,384
Two Reference Products with different Indications Two Reference Products with different Indications	prashantmohite	2014-06-06 07:15	1	2014-06-06 09:37	3,439
acceptance criteria for tacrolimus acceptance criteria for tacrolimus	Mahesh M	2014-06-03 08:46	1	2014-06-03 08:04	3,109
Cyclosporine sample size and design for BE study	kardambhatt	2014-05-30 08:15	0		1,838
Guideline for bioequivalence Zimbabwe	HV	2014-05-28 19:45	0		1,883
Selection of samples for Incurred Sample Reanalysis Selection of samples for Incurred Sample Reanalysis Selection of samples for Incurred Sample Reanalysis Selection of samples for Incurred Sample Reanalysis Selection of samples for Incurred Sample Reanalysis	Ken Peh	2014-05-22 19:42	4	2014-05-28 12:27	4,146
Veterinary bioequivalence Veterinary bioequivalence Veterinary bioequivalence Veterinary bioequivalence-VICH GL52 Veterinary bioequivalence-VICH GL52	Tina	2014-04-24 10:23	4	2014-05-22 11:19	4,863
Restriction Compliances Restriction Compliances Restriction Compliances Restriction Compliances	Irukulla Shravan Kumar	2014-04-24 07:31	3	2014-05-20 12:23	3,703
FDA’s Draft guidance on Demonstration of Biosimilarity FDA’s Draft guidance on Demonstration of Biosimilarity FDA’s Draft guidance on Demonstration of Biosimilarity	drgunasakaran1	2014-05-15 04:13	2	2014-05-18 15:34	3,480