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GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.
Nehls, Corey; Buonarati, Michael; Cape, Stephanie; Islam, Rafiq; Satterwhite, Christina; Briscoe, Chad; Hayes, Roger; Dinan, Andrew; Sales, Kurt; Anderson, Shelby; Vance, Jennifer; Lindsay, John; Zimmer, Jennifer; Couerbe, Philippe; Khadang, Ardeshir; Maasjo, Sarah; Bravo, Orlando; Lindley, Kathie; Moran, Liam; Sangster, Timothy; Vija, Jenifer; Stamatopoulos, John; Lin, Jenny; Reuschel, Scott; Underberg, Angie; MacNeill, Robert; Matassa, Luca; Spytko, Adriane; Garofolo, Wei; Savoie, Natasha; Rhyne, Paul; Ambrosius, Jason; Barra, Valentine; Dufield, Dawn; Luna, Marsha; Spriggs, Franklin; Fedorov, Evgueni; Ritzén, Hanna; Fatmi, Saadya; Kane, Cheikh; Bouhajib, Mohammed; DiMarco, Chantal; Iordachescu, Adriana; Tudoroniu, Ariana; Farley, Esme; Stouffer, Bruce; Tabler, Edward; McCown, Stacie; Bower, Joseph; Harrison, Travis.
Affiliation
  • Nehls C; PPD Laboratories, Richmond, Virginia, USA.
  • Buonarati M; Intertek, San Diego, California, USA.
  • Cape S; Covance, Madison, Wisconsin, USA.
  • Islam R; Celerion, Lincoln, Nebraska, USA.
  • Satterwhite C; Charles River Laboratories, Reno, Nevada, USA.
  • Briscoe C; PRA Health Sciences, Lenexa, Kansas, USA.
  • Hayes R; ICON Laboratory Services, Whitesboro, New York, USA.
  • Dinan A; Agilex Biolabs, Adelaide, Australia.
  • Sales K; Agilex Biolabs, Adelaide, Australia.
  • Anderson S; AIT Bioscience, Indianapolis, Indiana, USA.
  • Vance J; AIT Bioscience, Indianapolis, Indiana, USA.
  • Lindsay J; Altasciences, Everett, Washington, USA.
  • Zimmer J; Alturas Analytics, Moscow, Idaho, USA.
  • Couerbe P; Atlanbio, Saint-Nazaire, France.
  • Khadang A; Axis Clinicals, Dilworth, Minnesota, USA.
  • Maasjo S; Axis Clinicals, Dilworth, Minnesota, USA.
  • Bravo O; BASi, West Lafayette, Indiana, USA.
  • Lindley K; BioAgilytix, Durham, North Carolina, USA.
  • Moran L; Charles River Laboratories, Ashland, Ohio, USA.
  • Sangster T; Charles River Laboratories, Edinburgh, UK.
  • Vija J; Charles River Laboratories, Skokie, Illinois, USA.
  • Stamatopoulos J; CiToxLAB North America, Laval, Quebec, Canada.
  • Lin J; CMIC, Hoffman Estates, Illinois, USA.
  • Reuschel S; Covance, Salt Lake City, Utah, USA.
  • Underberg A; Covance, Madison, Wisconsin, USA.
  • MacNeill R; Envigo, Somerset, New Jersey, USA.
  • Matassa L; Frontage Lab, Exton, Pennsylvania, USA.
  • Spytko A; ICON Laboratory Services, Whitesboro, New York, USA.
  • Garofolo W; GCC, Toronto, Ontario, Canada.
  • Savoie N; GCC, Toronto, Ontario, Canada.
  • Rhyne P; Immunologix Laboratories, Tampa, Florida, USA.
  • Ambrosius J; Immunologix Laboratories, Tampa, Florida, USA.
  • Barra V; Intertek, San Diego, California, USA.
  • Dufield D; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA.
  • Luna M; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA.
  • Spriggs F; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA.
  • Fedorov E; Lambda Therapeutic Research, Toronto, Ontario, Canada.
  • Ritzén H; Mercodia AB, Uppsala, Sweden.
  • Fatmi S; NEOMED-LABS, Laval, Quebec, Canada.
  • Kane C; Pacific Biomarkers, Seattle, Washington, USA.
  • Bouhajib M; Pharma Medica Research Inc., Mississauga, Ontario, Canadian.
  • DiMarco C; Pharma Medica Research Inc., Mississauga, Ontario, Canadian.
  • Iordachescu A; Pharma Serv International, Bucharest, Romania.
  • Tudoroniu A; Pharma Serv International, Bucharest, Romania.
  • Farley E; Pharmaron, Germantown, Maryland, USA.
  • Stouffer B; PPD Laboratories, Richmond, Virginia, USA.
  • Tabler E; PPD Laboratories, Richmond, Virginia, USA.
  • McCown S; PRA Health Sciences, Lenexa, Kansas, USA.
  • Bower J; Precision for Medicine, Frederick, Maryland, USA.
  • Harrison T; Precision for Medicine, Redwood City, California, USA.
Bioanalysis ; 11(18s): 1-228, 2019 Sep.
Article in En | MEDLINE | ID: mdl-31565956
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.
Subject(s)
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biomarkers / Guidelines as Topic Type of study: Guideline Limits: Humans Language: En Journal: Bioanalysis Year: 2019 Document type: Article Affiliation country: United States
Fulltext
Add to My VHL
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biomarkers / Guidelines as Topic Type of study: Guideline Limits: Humans Language: En Journal: Bioanalysis Year: 2019 Document type: Article Affiliation country: United States