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. Application of commercial research-grade biomarker assays in drug development: is it time to create 'pharmaceutical-grade' kits?. (October 2012) Authors: Bowsher, Ronald R; Nowatzke, William; Sailstad, Jeffrey M; Khan, Masood U Journal: Bioanalysis Issue: Volume 4:Number 20(2012) Page Start: 2427 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Application of commercial research-grade biomarker assays in drug development: is it time to create 'pharmaceutical-grade' kits?. (October 2012) Authors: Bowsher, Ronald R; Nowatzke, William; Sailstad, Jeffrey M; Khan, Masood U Journal: Bioanalysis Issue: Volume 4:Number 20(2012) Page Start: 2427 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development. (January 2015) Authors: Khan, Masood U; Bowsher, Ronald R; Cameron, Mark; Devanarayan, Viswanath; Keller, Steve; King, Lindsay; Lee, Jean; Morimoto, Alyssa; Rhyne, Paul; Stephen, Laurie; Wu, Yuling; Wyant, Timothy; Lachno, D Richard Journal: Bioanalysis Issue: Volume 7:Number 2(2015) Page Start: 229 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development. (January 2015) Authors: Khan, Masood U; Bowsher, Ronald R; Cameron, Mark; Devanarayan, Viswanath; Keller, Steve; King, Lindsay; Lee, Jean; Morimoto, Alyssa; Rhyne, Paul; Stephen, Laurie; Wu, Yuling; Wyant, Timothy; Lachno, D Richard Journal: Bioanalysis Issue: Volume 7:Number 2(2015) Page Start: 229 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. Recommendations for clinical biomarker specimen preservation and stability assessments. (April 2017) Authors: Dakappagari, Naveen; Zhang, Hui; Stephen, Laurie; Amaravadi, Lakshmi; Khan, Masood U Journal: Bioanalysis Issue: Volume 9:Number 8(2017) Page Start: 643 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗