1. Conference Report: 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover. (April 2012) Authors: Lowes, Steve; Jersey, Jim; Shoup, Ronald; Garofolo, Fabio; Needham, Shane; Couerbe, Philippe; Lansing, Tim; Bhatti, Masood; Sheldon, Curtis; Hayes, Roger; Islam, Rafiq; Lin, Zhongping (John); Garofolo, Wei; Moussallie, Marc; Teixeira, Leonardo de Souza; Rocha, Thais; Jardieu, Paula; Truog, James;... Journal: Bioanalysis Issue: Volume 4:Number 7(2012) Page Start: 763 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. 8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation. (November 2014) Authors: Bower, Joseph; Fast, Douglas; Garofolo, Fabio; Gouty, Dominique; Hayes, Roger; Lowes, Steve; Nicholson, Robert; LeLacheur, Richard; Bravo, Jennifer; Shoup, Ronald; Dumont, Isabelle; Carbone, Mary; Zimmer, Jennifer; Ortuno, Jordi; Caturla, Maria Cruz; Datin, Jim; Lansing, Tim; Fatmi, Saadya; Struw... Journal: Bioanalysis Issue: Volume 6:Number 22(2014) Page Start: 2957 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC). (March 2012) Authors: Boterman, Mark; Doig, Mira; Breda, Massimo; Lowes, Steve; Jersey, Jim; Shoup, Ronald; Garofolo, Fabio; Dumont, Isabelle; Martinez, Suzanne; Needham, Shane; Caturla, Maria Cruz; Couerbe, Philippe; Guittard, Joelle; Maltas, John; Lansing, Tim; Bhatti, Masood; Schiebl, Christine; Struwe, Petra; Shel... Journal: Bioanalysis Issue: Volume 4:Number 6(2012) Page Start: 651 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗