4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.

The Global CRO Council for Bioanalysis (GCC) was formed in September 2010. Since then, the representatives of the member companies come together periodically to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry. The 4th GCC Closed Forum brought together experts from bioanalytical CROs to share and discuss recent issues in regulated bioanalysis, such as the impact of coadministered drugs on stability, some differences between European Medicines Agency and US FDA bioanalytical guidance documents and lessons learned following recent Untitled Letters. Recent 483s and agency findings, as well as issues on method carryover, were also part of the topics discussed.

Citation

Steve Lowes, Jim Jersey, Ronald Shoup, Fabio Garofolo, Shane Needham, Philippe Couerbe, Tim Lansing, Masood Bhatti, Curtis Sheldon, Roger Hayes, Rafiq Islam, Zhongping Lin, Wei Garofolo, Marc Moussallie, Leonardo de Souza Teixeira, Thais Rocha, Paula Jardieu, James Truog, Jenny Lin, Richard Lundberg, Alan Breau, Carmen Dilger, Mohammed Bouhajib, Ann Levesque, Sofi Gagnon-Carignan, Rand Jenkins, Robert Nicholson, Ming Hung Lin, Shane Karnik, William DeMaio, Kirk Smith, Laura Cojocaru, Mike Allen, Saadya Fatmi, Farhad Sayyarpour, Michele Malone, Xinping Fang. 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover. Bioanalysis. 2012 Apr;4(7):763-8

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PMID: 22512795

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