Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis. (June 2011)

• Record Type: Journal Article
• Authors: 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;
• Is Part Of: Bioanalysis. Volume 3:Number 12(2011)
• Page Start: 1323
• Page End: 1332
• Publication Date: 2011-06
• Subjects: bioanalysis -- bioanalytical CRO -- bioanalytical guidelines -- bioanalytical harmonization -- bioanalytical issues -- GCC -- Global CRO Council; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio.11.135
• Languages: English
• ISSNs: 1757-6180

Abstract

"" 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 ""