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Author/Creator Di Donato, Lorella

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
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Available online (eLD content is only available in our Reading Rooms) ↗

2. 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) ↗

3. 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) ↗

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