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. 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) ↗
6. Recommendations on biomarker bioanalytical method validation by GCC. (October 2012) Authors: Hougton, Richard; Gouty, Dominique; Allinson, John; Green, Rachel; Losauro, Mike; Lowes, Steve; LeLacheur, Richard; Garofolo, Fabio; Couerbe, Philippe; Bronner, Stéphane; Struwe, Petra; Schiebl, Christine; Sangster, Timothy; Pattison, Colin; Islam, Rafiq; Garofolo, Wei; Pawula, Maria; Buonarati, ... Journal: Bioanalysis Issue: Volume 4:Number 20(2012) Page Start: 2439 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. Recommendations on biomarker bioanalytical method validation by GCC. (October 2012) Authors: Hougton, Richard; Gouty, Dominique; Allinson, John; Green, Rachel; Losauro, Mike; Lowes, Steve; LeLacheur, Richard; Garofolo, Fabio; Couerbe, Philippe; Bronner, Stéphane; Struwe, Petra; Schiebl, Christine; Sangster, Timothy; Pattison, Colin; Islam, Rafiq; Garofolo, Wei; Pawula, Maria; Buonarati, ... Journal: Bioanalysis Issue: Volume 4:Number 20(2012) Page Start: 2439 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. 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) ↗
9. Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis. (June 2011) Authors: Lowes, Steve; Jersey, Jim; Shoup, Ronald; Garofolo, Fabio; Savoie, Natasha; Mortz, Ejvind; Needham, Shane; Caturla, Maria Cruz; Steffen, Ray; Sheldon, Curtis; Hayes, Roger; Samuels, Tim; Di Donato, Lorella; Kamerud, John; Michael, Steve; Lin, Zhongping (John); Hillier, Jim; Moussallie, Marc; de S... Journal: Bioanalysis Issue: Volume 3:Number 12(2011) Page Start: 1323 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
10. The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud. (April 2017) Authors: Cape, Stephanie; Islam, Rafiq; Nehls, Corey; Allinson, John; Safavi, Afshin; Bennett, Patrick; Hulse, James; Beaver, Chris; Khan, Masood; Karnik, Shane; Caturla, Maria Cruz; Lowes, Steve; Iordachescu, Adriana; Silvestro, Luigi; Tayyem, Rabab; Shoup, Ron; Mowery, Stephanie; Keyhani, Anahita; Wakef... Journal: Bioanalysis Issue: Volume 9:Number 7(2017) Page Start: 505 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗