1. 11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation. (20th April 2018) Authors: Islam, Rafiq; Briscoe, Chad; Bower, Joseph; Cape, Stephanie; Arnold, Mark; Hayes, Roger; Warren, Mark; Karnik, Shane; Stouffer, Bruce; Xiao, Yi Qun; van der Strate, Barry; Sikkema, Daniel; Fang, Xinping; Tudoroniu, Ariana; Tayyem, Rabab; Brant, Ashley; Spriggs, Franklin; Barry, Colin; Khan, Masoo... Journal: Bioanalysis Issue: Volume 10:Number 7(2018) Page Start: 433 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. 7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing. (October 2014) Authors: Rocci, Mario; Lowes, Steve; Shoup, Ronald; Garofolo, Fabio; Farmen, Raymond; Zhang, Tianyi; Allinson, John; Gouty, Dominique; Hayes, Roger; Nicholson, Robert; Houghton, Richard; Dumont, Isabelle; LeLacheur, Richard; Zimmer, Jennifer; Cruz Caturla, Maria; Couerbe, Philippe; Awaiye, Kayode; Fatmi, ... Journal: Bioanalysis Issue: Volume 6:Number 20(2014) Page Start: 2713 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. 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) ↗
4. 9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks. (March 2016) Authors: Hayes, Roger; LeLacheur, Richard; Dumont, Isabelle; Couerbe, Philippe; Safavi, Afshin; Islam, Rafiq; Pattison, Colin; Cape, Stephanie; Rocci, Mario; Briscoe, Chad; Cojocaru, Laura; Groeber, Elizabeth; Silvestro, Luigi; Bravo, Jennifer; Shoup, Ron; Verville, Manon; Zimmer, Jennifer; Caturla, Maria... Journal: Bioanalysis Issue: Volume 8:Number 6(2016) Page Start: 487 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. 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) ↗
6. Conference Report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars. (October 2012) Authors: Nicholson, Robert; Lowes, Steve; Caturla, Maria Cruz; Safavi, Afshin; Mamelak, Dan; Islam, Rafiq; Allinson, John; Gouty, Dominique; Khan, Masood; LeLacheur, Richard; Shoup, Ronald; Martinez, Suzanne; Dumont, Isabelle; Zimmer, Jennifer; Steffen, Ray; Petrilla, James; Awaiye, Kayode; Sheldon, Curti... Journal: Bioanalysis Issue: Volume 4:Number 19(2012) Page Start: 2335 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. Formation of a Global Contract Research Organization Council for Bioanalysis. (November 2010) Authors: Premkumar, Noel; Lowes, Stephen; Jersey, James; Garofolo, Fabio; Dumont, Isabelle; Masse, Robert; Stamatiou, Betty; Caturla, Maria C; Steffen, Ray; Malone, Michele; Offman, Elliot; Samuels, Timothy; Oldfield, Phillip; Di Donato, Lorella; Fast, Douglas; Tang, Daniel; Moussallie, Marc; Doughty, Joh... Journal: Bioanalysis Issue: Volume 2:Number 11(2010) Page Start: 1797 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC). (September 2012) Authors: Lowes, Steve; Boterman, Mark; Doig, Mira; Breda, Massimo; Jersey, Jim; LeLacheur, Richard; Shoup, Ronald; Garofolo, Fabio; Dumont, Isabelle; Martinez, Suzanne; Needham, Shane; Zimmer, Jennifer; Caturla, Maria Cruz; Couerbe, Philippe; Maltas, John; Steffen, Ray; Petrilla, James; Safavi, Afshin; Aw... Journal: Bioanalysis Issue: Volume 4:Number 17(2012) Page Start: 2117 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
9. Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC). (September 2012) Authors: Lowes, Steve; Boterman, Mark; Doig, Mira; Breda, Massimo; Jersey, Jim; LeLacheur, Richard; Shoup, Ronald; Garofolo, Fabio; Dumont, Isabelle; Martinez, Suzanne; Needham, Shane; Zimmer, Jennifer; Caturla, Maria Cruz; Couerbe, Philippe; Maltas, John; Steffen, Ray; Petrilla, James; Safavi, Afshin; Aw... Journal: Bioanalysis Issue: Volume 4:Number 17(2012) Page Start: 2117 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
10. Recommendations on incurred sample stability (ISS) by GCC. (September 2014) Authors: Lowes, Steve; LeLacheur, Richard; Shoup, Ronald; Garofolo, Fabio; Dumont, Isabelle; Martinez, Suzanne; Zimmer, Jennifer; Caturla, Maria Cruz; Couerbe, Philippe; Awaiye, Kayode; Fatmi, Saadya; Farmen, Raymond; Sheldon, Curtis; Bower, Joseph; Fiscella, Michele; Fast, Douglas; Cape, Stephanie; Hulse... Journal: Bioanalysis Issue: Volume 6:Number 18(2014) Page Start: 2385 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗