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. Bioavailability, Pharmacokinetics, and Safety of Belimumab Administered Subcutaneously in Healthy Subjects. Issue 4 (26th August 2013) Authors: Cai, Wendy W.; Fiscella, Michele; Chen, Cecil; Zhong, Z. John; Freimuth, William W.; Subich, David C. Journal: Clinical pharmacology in drug development Issue: Volume 2:Issue 4(2013:Oct.) Page Start: 349 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Electrophysiological Phenotype Characterization of Human iPSC‐Derived Neuronal Cell Lines by Means of High‐Density Microelectrode Arrays. Issue 3 (14th January 2021) Authors: Ronchi, Silvia; Buccino, Alessio Paolo; Prack, Gustavo; Kumar, Sreedhar Saseendran; Schröter, Manuel; Fiscella, Michele; Hierlemann, Andreas Journal: Advanced biology Issue: Volume 5:Issue 3(2021) Page Start: n/a Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. High-resolution CMOS MEA platform to study neurons at subcellular, cellular, and network levels1. Issue 13 (7th July 2015) Authors: Müller, Jan; Ballini, Marco; Livi, Paolo; Chen, Yihui; Radivojevic, Milos; Shadmani, Amir; Viswam, Vijay; Jones, Ian L.; Fiscella, Michele; Diggelmann, Roland; Stettler, Alexander; Frey, Urs; Bakkum, Douglas J.; Hierlemann, Andreas Journal: Lab on a chip Issue: Volume 15:Issue 13(2015) Page Start: 2767 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. Microelectrode Arrays: Electrophysiological Phenotype Characterization of Human iPSC‐Derived Neuronal Cell Lines by Means of High‐Density Microelectrode Arrays (Adv. Biology 3/2021). Issue 3 (17th March 2021) Authors: Ronchi, Silvia; Buccino, Alessio Paolo; Prack, Gustavo; Kumar, Sreedhar Saseendran; Schröter, Manuel; Fiscella, Michele; Hierlemann, Andreas Journal: Advanced biology Issue: Volume 5:Issue 3(2021) Page Start: n/a Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. Recommendations for the development and validation of confirmatory anti-drug antibody assays. (July 2015) Authors: Jani, Darshana; Marsden, Robin; Mikulskis, Alvydas; Gleason, Carol; Klem, Thomas; Krinos Fiorotti, Corinna; Myler, Heather; Yang, Lin; Fiscella, Michele Journal: Bioanalysis Issue: Volume 7:Number 13(2015) Page Start: 1619 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. Recommendations for the development and validation of confirmatory anti-drug antibody assays. (July 2015) Authors: Jani, Darshana; Marsden, Robin; Mikulskis, Alvydas; Gleason, Carol; Klem, Thomas; Krinos Fiorotti, Corinna; Myler, Heather; Yang, Lin; Fiscella, Michele Journal: Bioanalysis Issue: Volume 7:Number 13(2015) Page Start: 1619 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. 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 View Content: Available online (eLD content is only available in our Reading Rooms) ↗
9. 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) ↗