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

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

Author(s) -

Corey Nehls,

Michael H. Buonarati,

Stephanie Cape,

Rafiq Islam,

Christina Satterwhite,

Chad Briscoe,

Richard B. Hayes,

Andrew Dinan,

Kurt Sales,

Shelby R 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,

A. Iordăchescu,

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

Publication year - 2019

Publication title -

bioanalysis

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.566

H-Index - 58

eISSN - 1757-6199

pISSN - 1757-6180

DOI - 10.4155/bio-2019-0207

Subject(s) - guideline , bioanalysis , attendance , engineering , political science , nanotechnology , law , materials science

The 13 h GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5 h , 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.

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