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Richard Hougton,
Dominique Gouty,
John Allinson,
Rachel Green,
Mike Losauro,
Steve Lowes,
Richard Lelacheur,
Fabio Garofolo,
Philippe Couerbe,
Stéphane Bronner, [......],
Mark Cameron,
Robert Nicholson,
Jake Harman,
Jaap Wieling,
Theo De Boer,
Scott Reuschel,
Laura Cojocaru, Tammy Harter,
Michele Malone,
William Nowatzke
[show abstract]
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ABSTRACT: The 5th GCC in Barcelona (Spain) and 6th GCC in San Antonio (TX, USA) events provided a unique opportunity for CRO leaders to openly share opinions and perspectives, and to agree upon recommendations on biomarker bioanalytical method validation.
Bioanalysis 10/2012; 4(20):2439-46. · 3.22 Impact Factor
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Steve Lowes,
Mark Boterman,
Mira Doig,
Massimo Breda,
Jim Jersey,
Richard Lelacheur,
Ronald Shoup,
Fabio Garofolo,
Isabelle Dumont,
Suzanne Martinez, [......],
Pilar Gonzalez, Tammy Harter,
Saadya Fatmi,
Marie Rock,
Jenifer Vija,
Farhad Sayyarpour,
Michele Malone,
William Nowatzke,
Stuart Best,
Xinping Fang
[show abstract]
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ABSTRACT: 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.
Bioanalysis 09/2012; 4(17):2117-26. · 3.22 Impact Factor
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Timothy Sangster,
John Maltas,
Petra Struwe,
Jim Hillier,
Mark Boterman,
Mira Doig,
Massimo Breda,
Fabio Garofolo,
Maria Cruz Caturla,
Philippe Couerbe, [......],
Chris Cox,
Chiara Bigogno,
Dick Schoutsen,
Theo de Boer,
Rachel Green,
Richard Houghton,
Romuald Sable,
Christoff Siethoff, Tammy Harter,
Stuart Best
Bioanalysis 07/2012; 4(14):1723-30. · 3.22 Impact Factor
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Mark Boterman,
Mira Doig,
Massimo Breda,
Steve Lowes,
Jim Jersey,
Ronald Shoup,
Fabio Garofolo,
Isabelle Dumont,
Suzanne Martinez,
Shane Needham, [......],
Kirk Smith,
Christoph Siethoff,
Laura Cojocaru,
Mike Allen, Tammy Harter,
Saadya Fatmi,
Farhad Sayyarpour,
Michele Malone,
Stuart Best,
Xinping Fang
Bioanalysis 03/2012; 4(6):651-60. · 3.22 Impact Factor
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Massimo Breda,
Fabio Garofolo,
Maria Cruz Caturla,
Philippe Couerbe,
John Maltas,
Peter White,
Petra Struwe,
Timothy Sangster,
Suzanne Riches,
Jim Hillier, [......],
Maria Pawula,
Eileen Collins,
Dick Schoutsen,
Jaap Wieling,
Rachel Green,
Richard Houghton,
Bernard Jeanbaptiste,
Quinton Claassen, Tammy Harter,
Mark Seymour
[show abstract]
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ABSTRACT: The 3rd Global CRO Council Closed Forum was held on the 3rd and 4th July 2011 in Guildford, United Kingdom, in conjunction with the 19th International Reid Bioanalytical Forum. In attendance were 21 senior-level representatives from 19 CROs on behalf of nine European countries and, for many of the attendees, this occasion was the first time that they had participated in a GCC meeting. Therefore, this closed forum was an opportunity to increase awareness of the aim of the GCC and how it works, share information about bioanalytical regulations and audit findings from different agencies, their policies and procedures and also to discuss some topics of interest and aim to develop ideas and provide recommendations for bioanalytical practices at future GCC meetings in Europe.
Bioanalysis 12/2011; 3(24):2721-7. · 3.22 Impact Factor
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Steve Lowes,
Jim Jersey,
Ronald Shoup,
Fabio Garofolo,
Natasha Savoie,
Ejvind Mortz,
Shane Needham,
Maria Cruz Caturla,
Ray Steffen,
Curtis Sheldon, [......],
Richard Houghton,
Kirk Smith,
Laura Cojocaru,
Mike Allen, Tammy Harter,
Saadya Fatmi,
Farhad Sayyarpour,
Jenifer Vija,
Michele Malone,
Dennis Heller
[show abstract]
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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"
Bioanalysis 06/2011; 3(12):1323-32. · 3.22 Impact Factor
