Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.

Autor: Islam R; Celerion, Lincoln, NE, USA., Kar S; Celerion, Lincoln, NE, USA., Ritzén H; Mercodia AB, Uppsala, Sweden., Hays A; PRA Health Sciences, Lenexa, KS, USA., Tayyem R; ACDIMA Center for Bioequivalence & Pharmaceutical Studies, Amman, Jordan., Barry C; Alliance Pharma, Malvern, PA, USA., Keyhani A; Altasciences, Laval, QC, Canada., Zimmer J; Alturas Analytics, Moscow, ID, USA., Cruz Caturla M; Anapharm Bioanalytics, Barcelona, Spain., Couerbe P; Atlanbio, Saint-Nazaire, France., Warren M; Atlanbio, Saint-Nazaire, France., Khadang A; Axis Clinicals, Dilworth, MN, USA., Bourdage J; BASi, West Lafayette, IN, USA., Lindley K; BioAgilytix, Durham, NC, USA., Williams D; BioAgilytix, Durham, NC, USA., Hughes N; BioPharma Services, Toronto, ON, Canada., Sheldon C; Celerion, Lincoln, NE, USA., Satterwhite C; Charles River Laboratories, Reno, NV, USA., Vija J; Charles River Laboratories, Skokie, IL, USA., Yu M; CIRION Biopharma Research, Laval, QC, Canada., Boulay I; CiToxLAB North America, Laval, QC, Canada., Stamatopoulos J; CiToxLAB North America, Laval, QC, Canada., Lin J; CMIC, Hoffman Estates, IL, USA., Cape S; Covance, Madison, WI, USA., Estdale S; Covance, Harrogate, UK., Thomas E; Covance, Indianapolis, IN, USA., Dinan A; CPR Pharma Services, Adelaide, Australia., MacNeill R; Envigo, Somerset, NJ, USA., Xiao YQ; Envigo, Somerset, NJ, USA., Garofolo W; GCC, Toronto, ON, Canada., Savoie N; GCC, Toronto, ON, Canada., Brown M; ICON Laboratory Services, Whitesboro, NY, USA., Rhyne P; Immunologix Laboratories, Tampa, FL, USA., Hristopoulos G; Intertek, San Diego, CA, USA., Xu A; Intertek, San Diego, CA, USA., Goodwin L; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Spriggs F; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Xu A; Keystone Bioanalytical, North Wales, PA, USA., Awaiye K; Lambda Therapeutic Research, Toronto, ON, Canada., Hayes R; MPI Research, Mattawan, MI, USA., St Charles J; MPI Research, Mattawan, MI, USA., Bouhajib M; Pharma Medica Research Inc., Mississauga, ON, Canada., DiMarco C; Pharma Serv International, Bucharest, Romania., DiMarco L; Pharma Serv International, Bucharest, Romania., Savu SR; Pharma Serv International, Bucharest, Romania., Bennett P; PPD Laboratories, Richmond, VA, USA., Kakkanaiah V; PPD Laboratories, Richmond, VA, USA., Nehls C; PPD Laboratories, Richmond, VA, USA., Stouffer B; PPD Laboratories, Richmond, VA, USA., Tabler E; PPD Laboratories, Richmond, VA, USA., Briscoe C; PRA Health Sciences, Lenexa, KS, USA., Karnik S; Pyxant Labs, Colorado Springs, CO, USA., DuBey I; Smithers Avanza, Gaithersburg, MD, USA., Kulagina N; Smithers Avanza, Gaithersburg, MD, USA., Lindsay J; SNBL USA, Everett, WA, USA., Beaver C; Syneos Health, Princeton, NJ, USA., Williard C; Syneos Health, Princeton, NJ, USA., Wang H; TETRAQ, Herston, Australia., Feng H; Value Pharmaceutical Services, Nanjing, PR China., Malone M; Worldwide Clinical Trials, Austin, TX, USA., Wells E; Worldwide Clinical Trials, Austin, TX, USA., Fang X; WuXi Apptec, Plainsboro, NJ, USA., Moussallie M; WuXi Apptec, Plainsboro, NJ, USA.
Jazyk: angličtina
Zdroj: Bioanalysis [Bioanalysis] 2019 Apr; Vol. 11 (7), pp. 645-653. Date of Electronic Publication: 2019 Apr 17.
DOI: 10.4155/bio-2019-0072
Abstrakt: Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy. As the regulatory agencies are routinely making decisions based on biomarker data, there has been significant scrutiny on the validation of biomarker methods. Contract research organizations regularly use commercially available immunoassay kits to validate biomarker methods. However, adaptation of such kits in a regulated environment presents significant challenges and was one of the key topics discussed during the 12th Global Contract Research Organization Council for Bioanalysis (GCC) meeting. This White Paper reports the GCC members' opinion on the challenges facing the industry and the GCC recommendations on the classification of commercial kits that can be a win-win for commercial kit vendors and end users.
Databáze: MEDLINE