Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
IEC auditing IEC auditing	vivekanand	2012-08-27 10:05	1	2012-08-27 08:20	4,138
Deviation in Dosing as per Randomisation schedule Double blind – or not? Double blind – or not? Major protocol deviation	Mrugank	2012-08-18 18:22	3	2012-08-20 14:52	4,980
volunteers lab data validity period As short as possible As short as possible As short as possible As short as possible As short as possible As short as possible As short as possible As short as possible	kaushik089	2012-06-15 08:17	8	2012-06-20 12:11	10,655
Inclusion and Exclusion criteria Inclusion and Exclusion criteria Inclusion and Exclusion criteria	Varsha	2012-06-15 12:21	2	2012-06-16 06:40	4,741
Criteria check assessment of subjects Criteria check assessment of subjects Criteria check assessment of subjects Criteria check assessment of subjects Criteria check assessment of subjects Criteria check assessment of subjects Criteria check assessment of subjects	kapil pandya	2010-11-12 12:43	6	2012-05-14 13:35	8,126
Data reviewing process Data reviewing process	practical	2012-02-17 03:20	1	2012-02-17 08:55	3,861
checking of documents checking of documents checking of documents checking of documents checking of documents checking of documents checking of documents	Varsha	2011-05-30 13:45	6	2011-05-31 14:32	8,031
QA statement signature QA statement signature QA statement signature QA statement signature	jlanteigne	2011-03-02 16:24	3	2011-03-02 16:58	6,369
C of A C of A C of A C of A C of A C of A C of A C of A C of A	M.Vasu	2011-02-10 14:14	8	2011-02-22 08:42	8,571
Retention of Sample-USFDA Retention of Sample-USFDA Retention of Sample-USFDA	Rajdeep	2010-10-19 12:25	2	2010-11-16 10:35	6,911
Involvement of ISO Involvement of ISO	auditor	2010-10-28 08:44	1	2010-10-28 07:32	4,350
Who needs to sign the Protocol	raghavendra_s	2010-09-28 13:41	0		2,784
Contracted Phase 1 Trial QA & Compliance Contracted Phase 1 Trial QA & Compliance Contracted Phase 1 Trial QA & Compliance Contracted Phase 1 Trial QA & Compliance Contracted Phase 1 Trial QA & Compliance Contracted Phase 1 Trial QA & Compliance	raghavendra_s	2010-04-29 11:29	5	2010-06-02 09:33	6,894
master study schedule Master schedule	AKV	2010-05-26 12:14	1	2010-05-26 11:54	6,426
Can we use in other study- earlier screened but not enrolled Can we use already screened leftover subjects in other study Dr. Mengele Dr. Mengele Dr. Mengele Can we use already screened leftover subjects in other study	raghavendra_s	2010-05-25 09:15	5	2010-05-25 15:01	6,324