Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC). (March 2012)

• Record Type: Journal Article
• Authors: Boterman, Mark; Doig, Mira; Breda, Massimo; Lowes, Steve; Jersey, Jim; Shoup, Ronald; Garofolo, Fabio; Dumont, Isabelle; Martinez, Suzanne; Needham, Shane; Caturla, Maria Cruz; Couerbe, Philippe; Guittard, Joelle; Maltas, John; Lansing, Tim; Bhatti, Masood; Schiebl, Christine; Struwe, Petra; Sheldon, Curtis; Hayes, Roger; Sangster, Timothy; Pattison, Colin; Bouchard, Johanne; Goodwin, Lee; Islam, Rafiq; Segers, Rudi; Lin, Zhongping (John); Hillier, Jim; Garofolo, Wei; Zimmer, Dieter; Folguera, Lois; Zimmermann, Thomas; Pawula, Maria; Moussallie, Marc; de Souza Teixeira, Leonardo; Rocha, Thais; Tang, Daniel; Jardieu, Paula; Truog, James; Lin, Jenny; Lundberg, Richard; Cox, Chris; Breau, Alan; Bigogno, Chiara; Schoutsen, Dick; Dilger, Carmen; Bouhajib, Mohammed; Levesque, Ann; Gagnon-Carignan, Sofi; Nicholson, Robert; Jenkins, Rand; Lin, Ming Hung; Karnik, Shane; De Boer, Theo; Houghton, Richard; Green, Rachel; DeMaio, William; Sable, Romuald; Smith, Kirk; Siethoff, Christoph; Cojocaru, Laura; Allen, Mike; Harter, Tammy; Fatmi, Saadya; Sayyarpour, Farhad; Malone, Michele; Best, Stuart; Fang, Xinping;
• Is Part Of: Bioanalysis. Volume 4:Number 6(2012)
• Page Start: 651
• Page End: 660
• Publication Date: 2012-03
• Subjects: European Medicines Agency -- EMA -- FDA -- matrix selection -- reference standards -- stability; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio.12.18
• Languages: English
• ISSNs: 1757-6180