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

Authors:
Steve Lowes Mark Boterman Mira Doig Massimo Breda Jim Jersey Richard Lelacheur Ronald Shoup Fabio Garofolo Isabelle Dumont Suzanne Martinez Shane Needham Jennifer Zimmer Maria Cruz Caturla Philippe Couerbe John Maltas Ray Steffen James Petrilla Afshin Safavi Kayode Awaiye Masood Bhatti Curtis Sheldon Christine Schiebl Petra Struwe Douglas Turk Timothy Sangster Colin Pattison Douglas Fast Lee Goodwin John Kamerud Andrew Dinan Dan Mamelak Rafiq Islam Rudi Segers Zhongping John Lin Jim Hillier Wei Garofolo Lois Folguera Dieter Zimmer Thomas Zimmermann Maria Pawula Marc Moussallie Leonardo de Souza Teixeira Thais Rocha John Allinson Paula Jardieu Daniel Tang Dominique Gouty Laura Wright James Truog Jenny Lin Yasuhiro Yamashita Masood Khan Yansheng Liu Allan Xu Richard Lundberg Chris Cox Alan Breau Roger Hayes Chiara Bigogno Dick Schoutsen Carmen Dilger Jianine Jonker Mohammed Bouhajib Ann Levesque Sofi Gagnon-Carignan Jake Harman Robert Nicholson Rand Jenkins Mark Warren Ming Hung Lin Shane Karnik Theo De Boer Richard Houghton Rachel Green William Demaio Romuald Sable Kirk Smith Christoph Siethoff Laura Cojocaru Mike Allen Scott Reuschel Pilar Gonzalez Tammy Harter Saadya Fatmi Marie Rock Jenifer Vija Farhad Sayyarpour Michele Malone William Nowatzke Stuart Best Xinping Fang

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

Advion Bioanalytical Laboratories, Quintiles, NY, USA.

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.

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Source
http://dx.doi.org/10.4155/bio.12.192DOI Listing
September 2012

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