TY - JOUR
T1 - The 10th GCC Closed Forum
T2 - rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud
AU - Global CRO Council in Bioanalysis
AU - Cape, Stephanie
AU - Islam, Rafiq
AU - Nehls, Corey
AU - Allinson, John
AU - Safavi, Afshin
AU - Bennett, Patrick
AU - Hulse, James
AU - Beaver, Chris
AU - Khan, Masood
AU - Karnik, Shane
AU - Cruz Caturla, Maria
AU - Lowes, Steve
AU - Iordachescu, Adriana
AU - Silvestro, Luigi
AU - Tayyem, Rabab
AU - Shoup, Ron
AU - Mowery, Stephanie
AU - Keyhani, Anahita
AU - Wakefield, Andrea
AU - Li, Yinghe
AU - Zimmer, Jennifer
AU - Torres, Javier
AU - Couerbe, Philippe
AU - Khadang, Ardeshir
AU - Bourdage, James
AU - Hughes, Nicola
AU - Awaiye, Kayode
AU - Matthews, Brent
AU - Fatmi, Saadya
AU - Johnson, Rhonda
AU - Satterwhite, Christina
AU - Yu, Mathilde
AU - Lin, Jenny
AU - Cojocaru, Laura
AU - Fiscella, Michele
AU - Thomas, Eric
AU - Kurylak, Kai
AU - Kamerud, John
AU - Lin, Zhongping (John)
AU - Garofolo, Wei
AU - Savoie, Natasha
AU - Buonarati, Mike
AU - Boudreau, Nadine
AU - Williard, Clark
AU - Liu, Yansheng
AU - Warrino, Dominic
AU - Kale, Prashant
AU - Adcock, Neil
AU - Shekar, Radha
AU - van der Strate, Barry
PY - 2017/4
Y1 - 2017/4
N2 - The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud. In order to obtain the pharma perspectives on some of these topics, the first joint CRO-Pharma Scientific Interchange Meeting was held on 12 November 2016, in Denver, Colorado, USA. The five topics discussed at this Interchange meeting were reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, processed batch acceptance criteria and electronic laboratory notebooks and data integrity. The conclusions from the discussions of these topics at both meetings are included in this report.
AB - The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud. In order to obtain the pharma perspectives on some of these topics, the first joint CRO-Pharma Scientific Interchange Meeting was held on 12 November 2016, in Denver, Colorado, USA. The five topics discussed at this Interchange meeting were reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, processed batch acceptance criteria and electronic laboratory notebooks and data integrity. The conclusions from the discussions of these topics at both meetings are included in this report.
KW - bioanalysis
KW - GCC
KW - method validation
KW - GLOBAL CRO COUNCIL
KW - PART 2-HYBRID LBA/LCMS
KW - METHOD VALIDATION
KW - RECENT ISSUES
KW - WHITE PAPER
KW - REGULATORY AGENCIES
KW - RECOMMENDATIONS
KW - BIOMARKERS
KW - INPUT
KW - FOCUS
U2 - 10.4155/bio-2017-5000
DO - 10.4155/bio-2017-5000
M3 - Editorial
SN - 1757-6180
VL - 9
SP - 505
EP - 516
JO - Bioanalysis
JF - Bioanalysis
IS - 7
ER -