| Literature DB >> 31565956 |
Corey Nehls1, Michael Buonarati2, Stephanie Cape3, Rafiq Islam4, Christina Satterwhite5, Chad Briscoe6, Roger Hayes7, Andrew Dinan8, Kurt Sales8, Shelby Anderson9, Jennifer Vance9, John Lindsay10, Jennifer Zimmer11, Philippe Couerbe12, Ardeshir Khadang13, Sarah Maasjo13, Orlando Bravo14, Kathie Lindley15, Liam Moran16, Timothy Sangster17, Jenifer Vija18, John Stamatopoulos19, Jenny Lin20, Scott Reuschel21, Angie Underberg3, Robert MacNeill22, Luca Matassa23, Adriane Spytko7, Wei Garofolo24, Natasha Savoie24, Paul Rhyne25, Jason Ambrosius25, Valentine Barra2, Dawn Dufield26, Marsha Luna26, Franklin Spriggs26, Evgueni Fedorov27, Hanna Ritzén28, Saadya Fatmi29, Cheikh Kane30, Mohammed Bouhajib31, Chantal DiMarco31, Adriana Iordachescu32, Ariana Tudoroniu32, Esme Farley33, Bruce Stouffer1, Edward Tabler1, Stacie McCown6, Joseph Bower34, Travis Harrison35, Shane Karnik36, Michael Brown37, Philip Joyce38, Ira DuBey39, Brian Hoffpauir39, Nadine Boudreau40, Jerome Bergeron40, Hao Wang41, Hao Feng42, Shaolian Zhou43, Edward Wells43, John Pirro44, Xinping Fang44, Jing Shi45, Changming Yang45.
Abstract
The 13th GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5th, 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants from eight countries representing 44 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the ICH M10 Bioanalytical Method Validation Draft Guideline and to build unified comments to be provided to the ICH.Entities:
Year: 2019 PMID： 31565956 DOI： 10.4155/bio-2019-0207
Source DB: PubMed Journal: Bioanalysis ISSN： 1757-6180 Impact factor: 2.681