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11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.
Islam, Rafiq; Briscoe, Chad; Bower, Joseph; Cape, Stephanie; Arnold, Mark; Hayes, Roger; Warren, Mark; Karnik, Shane; Stouffer, Bruce; Xiao, Yi Qun; van der Strate, Barry; Sikkema, Daniel; Fang, Xinping; Tudoroniu, Ariana; Tayyem, Rabab; Brant, Ashley; Spriggs, Franklin; Barry, Colin; Khan, Masood; Keyhani, Anahita; Zimmer, Jennifer; Caturla, Maria Cruz; Couerbe, Philippe; Khadang, Ardeshir; Bourdage, James; Datin, Jim; Zemo, Jennifer; Hughes, Nicola; Fatmi, Saadya; Sheldon, Curtis; Fountain, Scott; Satterwhite, Christina; Colletti, Kelly; Vija, Jenifer; Yu, Mathilde; Stamatopoulos, John; Lin, Jenny; Wilfahrt, Jim; Dinan, Andrew; Ohorodnik, Susan; Hulse, James; Patel, Vimal; Garofolo, Wei; Savoie, Natasha; Brown, Michael; Papac, Damon; Buonarati, Mike; Hristopoulos, George; Beaver, Chris; Boudreau, Nadine.
Afiliação
  • Islam R; Celerion, Lincoln, NE, USA.
  • Briscoe C; PRA Health Sciences, Lenexa, KS, USA.
  • Bower J; Covance, Chantilly, VA, USA.
  • Cape S; Covance, Madison, WI, USA.
  • Arnold M; Covance, West Trenton, NJ, USA.
  • Hayes R; MPI Research, Mattawan, MI, USA.
  • Warren M; Atlanbio, Saint-Nazaire, France.
  • Karnik S; Pyxant Labs, Colorado Springs, CO, USA.
  • Stouffer B; PPD Laboratories, Richmond, VA, USA.
  • Xiao YQ; Envigo, Somerset, NJ, USA.
  • van der Strate B; PRA Health Sciences, Assen, The Netherlands.
  • Sikkema D; Frontage Lab, Exton, PA, USA.
  • Fang X; WuXi Apptec, Plainsboro, NJ, USA.
  • Tudoroniu A; 3S - Pharmacological Consultation, Bucharest, Romania.
  • Tayyem R; ACDIMA Center for Bioequivalence & Pharmaceutical Studies, Amman, Jordan.
  • Brant A; AIT Bioscience, Indianapolis, IN, USA.
  • Spriggs F; AIT Bioscience, Indianapolis, IN, USA.
  • Barry C; Alliance Pharma, Malvern, PA, USA.
  • Khan M; Alliance Pharma, Malvern, PA, USA.
  • Keyhani A; Algorithme Pharma, Laval, Quebec, Canada.
  • Zimmer J; Alturas Analytics, Moscow, ID, USA.
  • Caturla MC; Anapharm Europe, Barcelona, Spain.
  • Couerbe P; Atlanbio, Saint-Nazaire, France.
  • Khadang A; Axis Clinicals, Dilworth, MN, USA.
  • Bourdage J; BASi, West Lafayette, IN, USA.
  • Datin J; BioAgilytix, Durham, NC, USA.
  • Zemo J; BioAgilytix, Durham, NC, USA.
  • Hughes N; BioPharma Services, Toronto, Ontario, Canada.
  • Fatmi S; Biotrial Bioanalytical Services Inc., Laval, Quebec, Canada.
  • Sheldon C; Celerion, Lincoln, NE, USA.
  • Fountain S; Charles River Laboratories, Reno, NV, USA.
  • Satterwhite C; Charles River Laboratories, Reno, NV, USA.
  • Colletti K; Charles River Laboratories, Reno, NV, USA.
  • Vija J; Charles River Laboratories, Skokie, IL, USA.
  • Yu M; CIRION Biopharma Research, Laval, Quebec, Canada.
  • Stamatopoulos J; CiToxLAB North America, Laval, Quebec, Canada.
  • Lin J; CMIC, Hoffman Estates, IL, USA.
  • Wilfahrt J; Covance, Salt Lake City, UT, USA.
  • Dinan A; CPR Pharma Services, Adelaide, Australia.
  • Ohorodnik S; Envigo, Somerset, NJ, USA.
  • Hulse J; Eurofins Pharma Bioanalytics Services, Saint Charles, MO, USA.
  • Patel V; Eurofins Pharma Bioanalytics Services, Moorpark, CA, USA.
  • Garofolo W; GCC, Toronto, Ontario, Canada.
  • Savoie N; GCC, Toronto, Ontario, Canada.
  • Brown M; ICON Clinical, Whitesboro, NY, USA.
  • Papac D; ICON Laboratory Services, Whitesboro, NY, USA.
  • Buonarati M; Intertek, San Diego, CA, USA.
  • Hristopoulos G; Intertek, San Diego, CA, USA.
  • Beaver C; inVentiv Health, Quebec City, Quebec, Canada.
  • Boudreau N; inVentiv Health, Quebec City, Quebec, Canada.
Bioanalysis ; 10(7): 433-444, 2018 Apr 01.
Article em En | MEDLINE | ID: mdl-29701066
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Bioensaio / Biomarcadores / Medicamentos Biossimilares Tipo de estudo: Guideline Limite: Humans País/Região como assunto: Asia Idioma: En Revista: Bioanalysis Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Bioensaio / Biomarcadores / Medicamentos Biossimilares Tipo de estudo: Guideline Limite: Humans País/Região como assunto: Asia Idioma: En Revista: Bioanalysis Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Estados Unidos