Literature DB >> 23013394

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

Steve Lowes1, 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.   

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.

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Year:  2012        PMID: 23013394     DOI: 10.4155/bio.12.192

Source DB:  PubMed          Journal:  Bioanalysis        ISSN: 1757-6180            Impact factor:   2.681


  3 in total

1.  Method transfer, partial validation, and cross validation: recommendations for best practices and harmonization from the global bioanalysis consortium harmonization team.

Authors:  R J Briggs; R Nicholson; F Vazvaei; J Busch; M Mabuchi; K S Mahesh; M Brudny-Kloeppel; N Weng; P A R Galvinas; P Duchene; Pei Hu; R W Abbott
Journal:  AAPS J       Date:  2014-09-05       Impact factor: 4.009

Review 2.  Stability: recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization Team.

Authors:  Nico van de Merbel; Natasha Savoie; Manish Yadav; Yoshiaki Ohtsu; Joleen White; Maria Francesca Riccio; Kelly Dong; Ronald de Vries; Julie Diancin
Journal:  AAPS J       Date:  2014-02-19       Impact factor: 4.009

3.  AAPS Workshop Report on ICH M10.

Authors:  Brian Booth; Faye Vazvaei; Eric Fluhler; Heather Myler; Eric Woolf
Journal:  AAPS J       Date:  2019-12-10       Impact factor: 4.009

  3 in total

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