Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
QA Audit Procedure QA Audit Procedure QA Audit Procedure QA Audit Procedure QA Audit Procedure QC # QA QC # QA QC # QA QC # QA ISO17025 is King QC # QA QC # QA QC # QA QC # QA QC # QA QC # QA QC # QA Waste of time QC # QA QC # QA QC According to ICH E3 QC According to ICH E3 BE Report: Recommendations to the structure BE creative!	swapnil.kuche	2011-01-20 06:47	23	2014-01-22 19:53	26,240
Pilot BE Study Pilot BE Study (GMP requirement) Pilot BE Study (GMP requirement) Pilot BE Study (GMP requirement) Pilot BE Study Pilot BE Report	balvanth	2012-07-09 13:33	5	2013-11-22 07:33	12,032
Obtaining Informed Consent Obtaining Informed Consent Obtaining Informed Consent Obtaining Informed Consent	Irukulla Shravan Kumar	2013-08-13 11:03	3	2013-08-14 03:29	5,717
GCP facility checklist GCP facility checklist First: Good morning GCP facility checklist	manoj	2013-07-17 14:49	3	2013-07-17 14:48	6,144
medical weight and height scale	gracehung	2013-06-09 06:10	0		3,131
CAPAs, effectiveness of training Proof of absence?	ElMaestro	2013-06-08 11:07	1	2013-06-08 12:59	5,015
Auditing of CRO QA (Quality Assurance) Auditing of CRO QA (Quality Assurance)	vivekanand	2013-05-25 06:21	1	2013-05-29 06:27	4,504
institutional ethics committee audit institutional ethics committee audit institutional ethics committee audit	vivekanand	2013-05-24 14:17	2	2013-05-24 16:12	4,983
GLP vs. ISO17025 for bioanalysis GLP vs. ISO17025 for bioanalysis GLP vs. ISO17025 for bioanalysis	ElMaestro	2013-05-03 01:26	2	2013-05-11 14:27	6,402
Accreditations specific for bioanalytical laboratories Accreditations specific for bioanalytical laboratories Accreditations specific for bioanalytical laboratories	Tina	2013-05-07 13:42	2	2013-05-07 15:50	5,014
SOP SOP SOP SOP	Ken Peh	2013-03-20 17:01	3	2013-03-21 16:19	6,176
Regarding completion of period from a subject Regarding completion of period from a subject	vivekanand	2012-11-16 11:47	1	2012-11-16 14:51	4,687
Informed Consent and Adverse events Informed Consent and Adverse events Informed Consent and Adverse events Informed Consent and Adverse events Informed Consent and Adverse events	yogesh1004	2012-10-09 06:36	4	2012-10-10 04:30	5,455
Facility inspection by UKMHRA/EU Facility inspection by UKMHRA/EU Facility inspection by UKMHRA/EU No GCP “certificate” for BE-centers issued by EU countries No GCP “certificate” for BE-centers issued by EU countries (Bad) experiences… No GCP “certificate” for BE-centers issued by EU countries No GCP “certificate” for BE-centers issued by EU countries	cakhatri	2012-10-07 11:30	7	2012-10-09 05:16	7,461
Evidences for GCP Evidences for GCP Evidence? Evidence?	Jasim Uddin	2012-08-23 20:52	3	2012-09-04 10:06	6,486