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Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars.

Nicholson, Robert; Lowes, Steve; Caturla, Maria Cruz; Safavi, Afshin; Mamelak, Dan; Islam, Rafiq; Allinson, John; Gouty, Dominique; Khan, Masood; Lelacheur, Richard; Shoup, Ronald; Martinez, Suzanne; Dumont, Isabelle; Zimmer, Jennifer; Steffen, Ray; Petrilla, James; Awaiye, Kayode; Sheldon, Curtis; Turk, Douglas; Fast, Douglas; Kamerud, John; Dinan, Andrew; Lin, Zhongping John; Garofolo, Wei; Tang, Daniel; Wright, Laura; Lin, Jenny; Yamashita, Yasuhiro; Liu, Yansheng; Xu, Allan; Hayes, Roger; Bouhajib, Mohammed; Levesque, Ann; Gagnon-Carignan, Sofi; Harman, Jake; Warren, Mark; Karnik, Shane; Cojocaru, Laura; Reuschel, Scott; Gonzalez, Pilar; Fatmi, Saadya; Vija, Jenifer; Rock, Marie; Malone, Michele; Nowatzke, William; Fang, Xinping.

Bioanalysis ; 4(19): 2335-42, 2012 Oct.

Artículo en Inglés | MEDLINE | ID: mdl-23088460

Asunto(s)

Biomarcadores/análisis , Biosimilares Farmacéuticos/análisis , Preparaciones Farmacéuticas/análisis , Biosimilares Farmacéuticos/farmacocinética , Biosimilares Farmacéuticos/normas , Cromatografía Líquida de Alta Presión/normas , Industria Farmacéutica , Espectrometría de Masas/normas , Preparaciones Farmacéuticas/normas , Control de Calidad , Estándares de Referencia

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).

Lowes, Steve; Boterman, Mark; Doig, Mira; Breda, Massimo; Jersey, Jim; Lelacheur, Richard; Shoup, Ronald; Garofolo, Fabio; Dumont, Isabelle; Martinez, Suzanne; Needham, Shane; Zimmer, Jennifer; Caturla, Maria Cruz; Couerbe, Philippe; Maltas, John; Steffen, Ray; Petrilla, James; Safavi, Afshin; Awaiye, Kayode; Bhatti, Masood; Sheldon, Curtis; Schiebl, Christine; Struwe, Petra; Turk, Douglas; Sangster, Timothy; Pattison, Colin; Fast, Douglas; Goodwin, Lee; Kamerud, John; Dinan, Andrew; Mamelak, Dan; Islam, Rafiq; Segers, Rudi; Lin, Zhongping John; Hillier, Jim; Garofolo, Wei; Folguera, Lois; Zimmer, Dieter; Zimmermann, Thomas; Pawula, Maria; Moussallie, Marc; de Souza Teixeira, Leonardo; Rocha, Thais; Allinson, John; Jardieu, Paula; Tang, Daniel; Gouty, Dominique; Wright, Laura; Truog, James; Lin, Jenny.

Bioanalysis ; 4(17): 2117-26, 2012 Sep.

Artículo en Inglés | MEDLINE | ID: mdl-23013394

RESUMEN

An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years.

Asunto(s)

Combinación de Medicamentos , Preparaciones Farmacéuticas/análisis , Tecnología Farmacéutica/normas , Biomarcadores/análisis , Cromatografía Líquida de Alta Presión/métodos , Estabilidad de Medicamentos , Regulación Gubernamental , Guías como Asunto , Humanos , Espectrometría de Masas en Tándem/métodos

Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.

Lowes, Steve; Jersey, Jim; Shoup, Ronald; Garofolo, Fabio; Savoie, Natasha; Mortz, Ejvind; Needham, Shane; Caturla, Maria Cruz; Steffen, Ray; Sheldon, Curtis; Hayes, Roger; Samuels, Tim; Di Donato, Lorella; Kamerud, John; Michael, Steve; Lin, Zhongping John; Hillier, Jim; Moussallie, Marc; de Souza Teixeira, Leonardo; Rocci, Mario; Buonarati, Mike; Truog, James; Hussain, Saleh; Lundberg, Richard; Breau, Alan; Zhang, Tianyi; Jonker, Jianine; Berger, Neil; Gagnon-Carignan, Sofi; Nehls, Corey; Nicholson, Robert; Hilhorst, Martijn; Karnik, Shane; de Boer, Theo; Houghton, Richard; Smith, Kirk; Cojocaru, Laura; Allen, Mike; Harter, Tammy; Fatmi, Saadya; Sayyarpour, Farhad; Vija, Jenifer; Malone, Michele; Heller, Dennis.

Bioanalysis ; 3(12): 1323-32, 2011 Jun.

Artículo en Inglés | MEDLINE | ID: mdl-21679026

RESUMEN

"The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry"

Asunto(s)

Biofarmacia/normas , Técnicas de Química Analítica/normas , Estándares de Referencia , Técnicas de Química Analítica/métodos , Estabilidad de Medicamentos , Cooperación Internacional , Control de Calidad

Formation of a Global Contract Research Organization Council for Bioanalysis.

Premkumar, Noel; Lowes, Stephen; Jersey, James; Garofolo, Fabio; Dumont, Isabelle; Masse, Robert; Stamatiou, Betty; Caturla, Maria C; Steffen, Ray; Malone, Michele; Offman, Elliot; Samuels, Timothy; Oldfield, Phillip; Di Donato, Lorella; Fast, Douglas; Tang, Daniel; Moussallie, Marc; Doughty, John; Rocci, Mario; Buonarati, Mike; Gouty, Dominique; Dadgar, Darioush; Stamatopoulos, John; Breau, Alan; Ntsikoussalabongui, Bernard; Bouhajib, Mohammed; Nicholson, Bob; Tacey, Richard; Ketelaar, Peter; Briscoe, Chad; Karnik, Shane; Wieling, Jaap; Smith, Jon Kirk; Reid, Michael J; Lelacheur, Richard; Chapdelaine, John; Fatmi, Saadya; Sayyarpour, Farhad; Fang, Xinping; Cook, Jeremy; Browne, David.

Bioanalysis ; 2(11): 1797-800, 2010 Nov.

Artículo en Inglés | MEDLINE | ID: mdl-21083485

Asunto(s)

Técnicas de Química Analítica/métodos , Técnicas de Química Analítica/normas , Cooperación Internacional , Investigación , Sociedades Científicas/organización & administración , Guías como Asunto

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