1. 8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation
- Author
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Isabelle Dumont, Paul Rhyne, Saadya Fatmi, Curtis Sheldon, Rafiq Islam, Yanseng Liu, Roger Hayes, Dick Tacey, William Nowatzke, Gene Ray, Jenny Lin, Jennifer Bravo, Gary Schultz, Robert Nicholson, Barry van der Strate, Jim Datin, Chad Briscoe, Elizabeth Groeber, Teri Pekol, Tim Lansing, Jordi Ortuno, Rand Jenkins, Ira DuBey, Andrew Roberts, Mike Buonarati, Andrea Watson, Douglas M. Fast, John Lin, John Kamerud, Mathilde Yu, Daniel Tang, Michele Malone, Laura Cojocaru, Allan Xu, Petra Struwe, Masood Khan, Ann Levesque, Richard LeLacheur, Kai Kurylak, Colin Farrell, Steve Lowes, Mohammed Bouhajib, Ronald Shoup, John Doughty, Joseph Bower, Gibran El-Sulayman, Chantal DiMarco, Alexandre Blanchette, Mary Carbone, Phyllis Conliffe, Fabio Garofolo, Dominique Gouty, Jim Hulse, Jamil Hantash, Jennifer Zimmer, Mike Redrup, Scott Reuschel, Sofi Gagnon-Carignan, Maria Cruz Caturla, Mike Allen, Wei Garofolo, Xinping Fang, and Shane Karnik
- Subjects
Medical Laboratory Technology ,Engineering management ,Engineering ,business.industry ,Clinical Biochemistry ,Nanotechnology ,General Medicine ,Validation Studies as Topic ,General Pharmacology, Toxicology and Pharmaceutics ,business ,Analytical Chemistry - Abstract
The 8th GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation – The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the draft FDA Guidance, and to build unified comments to be provided to the FDA.
- Published
- 2014
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