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. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity). (November 2016) Authors: Richards, Susan; Amaravadi, Lakshmi; Pillutla, Renuka; Birnboeck, Herbert; Torri, Albert; Cowan, Kyra J.; Papadimitriou, Apollon; Garofolo, Fabio; Satterwhite, Christina; Piccoli, Steven; Wu, Bonnie; Krinos-Fiorotti, Corinna; Allinson, John; Berisha, Flora; Cocea, Laurent; Croft, Stephanie; Frase... Journal: Bioanalysis Issue: Volume 8:Number 23(2016) Page Start: 2475 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. 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) ↗
4. 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) ↗