1. 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) ↗
2. Changing shape: evolving an outsourced bioanalytical strategy to support the changing needs of drug development. (August 2017) Authors: Stovold, Craig; Milligan, Fiona; Hawthorne, Glen; Pattison, Colin; Wilson, Amanda Journal: Bioanalysis Issue: Volume 9:Number 15(2017) Page Start: 1135 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. 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) ↗
4. 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) ↗
5. 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) ↗
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 ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC). (July 2012) Authors: Sangster, Timothy; Maltas, John; Struwe, Petra; Hillier, Jim; Boterman, Mark; Doig, Mira; Breda, Massimo; Garofolo, Fabio; Caturla, Maria Cruz; Couerbe, Philippe; Schiebl, Christine; Pattison, Colin; Goodwin, Lee; Segers, Rudi; Garofolo, Wei; Folguera, Lois; Zimmer, Dieter; Zimmerman, Thomas; Paw... Journal: Bioanalysis Issue: Volume 4:Number 14(2012) Page Start: 1723 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. 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) ↗