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. Assay development for determination of tenofovir in human plasma by solid phase analytical derivatization and LC–MS/MS. (December 2015) Authors: Podany, Anthony T; Sheldon, Curtis; Grafelman, Daryl; Ohnmacht, Corey M Journal: Bioanalysis Issue: Volume 7:Number 24(2015) Page Start: 3085 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. Comparison of the Pharmacokinetics of Ketorolac Tromethamine After Continuous Subcutaneous Infusion and Repeat Intramuscular Bolus Injections in Healthy Adult Subjects. Issue 4 (11th January 2017) Authors: Burdick, Michael; Mamelok, Richard; Hurliman, Michele; Dupuis, Mariève; Xie, Yuli; Grenier, Julie; Sheldon, Curtis; Gartner, Michael; Noymer, Peter Journal: Clinical pharmacology in drug development Issue: Volume 6:Issue 4(2017) Page Start: 343 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. 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) ↗
8. 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) ↗
9. Is anuria prior to pediatric renal transplantation associated with poor allograft outcomes?. (8th May 2019) Authors: Alam, Zaheer; VanderBrink, Brian A.; Brewer, Nathalie; Hooper, David; Tiao, Greg; Alonso, Maria; Nathan, Jaimie; DeFoor, W. Robert; Sheldon, Curtis; Reddy, Pramod P. Journal: Pediatric transplantation Issue: Volume 23:Number 5(2019) Page Start: n/a Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
10. 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) ↗