Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
For Canada submission For Canada submission For Canada submission	suchit_bhavsar	2011-04-04 10:23	2	2011-04-08 07:29	3,183
Canadian reference product	mvgchakravarthi	2011-04-05 17:26	0		2,347
Health Canada Submission: full replicate BE study allowed? Replicate design(s): why not? Replicate design(s): why not? Replicate design(s): why not? Replicate design(s): why not? No concentration after reference product	luvblooms	2011-04-01 14:33	5	2011-04-05 11:58	4,410
Canada MR Canada MR: MD if accumulation likely Canada MR: MD if accumulation likely	Paresh	2011-03-25 09:02	2	2011-03-26 09:08	2,753
Sub-investigators on 1572 form Sub-investigators on 1572 form Sub-investigators on 1572 form and financial discosure Sub-investigators on 1572 form and financial discosure Sub-investigators on 1572 form and financial discosure	jlanteigne	2011-03-23 23:14	4	2011-03-25 19:04	4,645
Guidance on MR oral and transdermal dosage forms MR fasting/fed MR fasting/fed EU-MR: no food effect ⇒ fed study EU-MR: no food effect ⇒ fed study EU-MR: no food effect ⇒ fed study DNFTT	rohitkachhadiya	2011-03-21 10:29	6	2011-03-24 11:36	4,293
TGA: old or new EU GL? TGA: new EU GL not adopted yet TGA: new EU GL not adopted yet TGA: BE on AUCt	Paresh	2011-03-18 07:07	3	2011-03-21 12:57	3,823
Retension Period Retension Period	sruman	2011-03-21 07:24	1	2011-03-21 09:49	2,811
one drug substance, 2 brands with different indications one drug substance, 2 brands with different indications one drug substance, 2 brands with different indications one drug substance, 2 brands with different indications one drug substance, 2 brands with different indications	Shuanghe	2011-03-18 11:59	4	2011-03-21 09:10	4,304
ICH-GCP Informed Consent Procedure ICH-GCP Informed Consent Procedure	swapnil.kuche	2011-03-17 08:15	1	2011-03-17 09:14	3,261
Need of chiral assay (EU) Need of chiral assay (EU) BE of active, PK of inactive (EU)	HV	2011-02-22 10:49	2	2011-03-09 14:33	3,796
BE studies for NDAs	Phaneendra.K	2011-03-09 09:03	0		1,803
Hospitalization of volunteers Hospitalization of volunteers Hospitalization of volunteers Hospitalization of volunteers Hospitalization of volunteers	konkous	2011-03-01 21:08	4	2011-03-05 11:38	3,163
New EU Annex 11	jlanteigne	2011-03-03 21:03	0		1,679
Draft EMA Guideline on Drug Interactions	vezz	2011-03-01 12:53	0		2,130