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	4,142
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	4,984
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	10,661
Inclusion and Exclusion criteria Inclusion and Exclusion criteria Inclusion and Exclusion criteria	Varsha	2012-06-15 12:21	2	2012-06-16 06:40	4,743
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	8,131
Data reviewing process Data reviewing process	practical	2012-02-17 03:20	1	2012-02-17 08:55	3,864
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	8,035
QA statement signature QA statement signature QA statement signature QA statement signature	jlanteigne	2011-03-02 16:24	3	2011-03-02 16:58	6,372
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	8,573
Retention of Sample-USFDA Retention of Sample-USFDA Retention of Sample-USFDA	Rajdeep	2010-10-19 12:25	2	2010-11-16 10:35	6,914
Involvement of ISO Involvement of ISO	auditor	2010-10-28 08:44	1	2010-10-28 07:32	4,353
Who needs to sign the Protocol	raghavendra_s	2010-09-28 13:41	0		2,785
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	6,899
master study schedule Master schedule	AKV	2010-05-26 12:14	1	2010-05-26 11:54	6,428
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	6,327