GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline

• DOI: 10.4155/bio-2019-0207
• Publication Date: 2019-09-30T12:19:06Z
• Authors: Corey Nehls; Michael Buonarati; Stephanie Cape; Rafiq Islam; Christina Satterw...; Chad Briscoe; Roger Hayes; Andrew Dinan; Kurt Sales; Shelby Anderson; Jennifer Vance; John Lindsay; Jennifer Zimmer; Philippe Couerbe; Ardeshir Khadang; Sarah Maasjo; Orlando Bravo; Kathie Lindley; Liam Moran; Timothy Sangster; Jenifer Vija; John Stamatopoulos; Jenny Lin; Scott Reuschel; Angie Underberg; Robert MacNeill; Luca Matassa; Adriane Spytko; Wei Garofolo; Natasha Savoie; Paul Rhyne; Jason Ambrosius; Valentine Barra; Dawn Dufield; Marsha Luna; Franklin Spriggs; Evgueni Fedorov; Hanna Ritzén; Saadya Fatmi; Cheikh Kane; Mohammed Bouhajib; Chantal DiMarco; Adriana Iordachescu; Ariana Tudoroniu; Esme Farley; Bruce Stouffer; Edward Tabler; Stacie McCown; Joseph Bower; Travis Harrison; Shane Karnik; Michael Brown; Philip Joyce; Ira DuBey; Brian Hoffpauir; Nadine Boudreau; Jerome Bergeron; Hao Wang; Hao Feng; Shaolian Zhou; Edward Wells; John Pirro; Xinping Fang; Jing Shi; Changming Yang
• Keywords: 03 medical and health sciences; 0302 clinical medicine; Research Design; Humans; Reproducibility of Results; Guidelines as Topic; Biomarkers

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.