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. 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) ↗
3. 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) ↗
4. Validation and life-cycle management of a quantitative ligand-binding assay for the measurement of Nulojix®, a CTLA-4–Fc fusion protein, in renal and liver transplant patients. (May 2012) Authors: Myler, Heather A; Phillips, Kelli R; Dong, Huijin; Tabler, Edward; Shaikh, Mehmooda; Coats, Valarie; Hay, Laura; Tacey, Richard; Stouffer, Bruce Journal: Bioanalysis Issue: Volume 4:Number 10(2012) Page Start: 1215 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. Validation and life-cycle management of a quantitative ligand-binding assay for the measurement of Nulojix®, a CTLA-4–Fc fusion protein, in renal and liver transplant patients. (May 2012) Authors: Myler, Heather A; Phillips, Kelli R; Dong, Huijin; Tabler, Edward; Shaikh, Mehmooda; Coats, Valarie; Hay, Laura; Tacey, Richard; Stouffer, Bruce Journal: Bioanalysis Issue: Volume 4:Number 10(2012) Page Start: 1215 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗