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

Mark Boterman,Mira Doig,Massimo Breda,Steve Lowes,Jim Jersey,Ronald Shoup,Fabio Garofolo,Isabelle Dumont,Suzanne Martinez,Shane Needham,Maria Cruz Caturla,Philippe Couerbe,Joelle Guittard,John Maltas,Tim Lansing,Masood Bhatti,Christine Schiebl,Petra Struwe,Curtis Sheldon,Roger Hayes,Timothy Sangster,Colin Pattison, Johanne Bouchard,Lee Goodwin,Rafiq Islam, Rudi Segers,Zhongping John Lin,Jim Hillier,Wei Garofolo,Dieter Zimmer,Lois Folguera,Thomas Zimmermann,Maria Pawula,Marc Moussallie,Leonardo de Souza Teixeira,Thais Rocha,Daniel Tang,Paula Jardieu,James Truog,Jenny Lin,Richard Lundberg,Chris Cox,Alan Breau,Chiara Bigogno,Dick Schoutsen,Carmen Dilger,Mohammed Bouhajib,Ann Levesque,Sofi Gagnon-Carignan,Robert Nicholson,Rand Jenkins,Ming Hung Lin,Shane Karnik,Theo De Boer,Richard Houghton,Rachel Green,William DeMaio, Romuald Sable,Kirk Smith, Christoph Siethoff,Laura Cojocaru,Mike Allen,Tammy Harter,Saadya Fatmi,Farhad Sayyarpour,Michele Malone,Stuart Best,Xinping Fang

BIOANALYSIS（2012）

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Abstract

These North American and European events provided a unique opportunity for CRO leaders to openly share opinions and perspectives and to agree on unified bioanalytical recommendations specifically in relation with the new EMA guideline.

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Key words

European Medicines Agency,EMA,FDA,matrix selection,reference standards,stability

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