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Author/Creator Cape, Stephanie

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
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2. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 – small molecules, peptides and small molecule biomarkers by LCMS). (November 2016)

Authors:
Yang, Eric; Welink, Jan; Cape, Stephanie; Woolf, Eric; Sydor, Jens; James, Christopher; Goykhman, Dina; Arnold, Mark; Addock, Neil; Bauer, Ronald; Buonarati, Michael; Ciccimaro, Eugene; Dodda, Raj; Evans, Christopher; Garofolo, Fabio; Hughes, Nicola; Islam, Rafiq; Nehls, Corey; Wilson, Amanda; Br...
Journal:
Bioanalysis
Issue:
Volume 8:Number 22(2016)
Page Start:
2363
Record Type:
Journal Article
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3. 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
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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
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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
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Available online (eLD content is only available in our Reading Rooms) ↗