The determination of Sulfobutylether β-Cyclodextrin Sodium (SBECD) by LC-MS/MS and its application in remdesivir pharmacokinetics study for pediatric patients
Yang, Zhengdong, Xiao, Deqing, Ling, Kah Hiing John, Tarnowski, Thomas, Humeniuk, Rita, Parmentier, Bryan, Fu, Yu-Hui Ann, Johnson, Eric, Luna, Marsha L., Goudarzi, Habibi, Cheng, Quan
Published in Journal of pharmaceutical and biomedical analysis (01.04.2022)
Published in Journal of pharmaceutical and biomedical analysis (01.04.2022)
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Recommendations on qPCR/ddPCR assay validation by GCC
Wissel, Mark, Poirier, Martin, Satterwhite, Christina, Lin, John, Islam, Rafiq, Zimmer, Jennifer, Khadang, Ardeshir, Zemo, Jennifer, Lester, Todd, Fjording, Marianne, Hays, Amanda, Hughes, Nicola, Garofolo, Fabio, Guilbaud, Rudolf, Groeber, Elizabeth, Renfrew, Heidi, Colletti, Kelly, Yu, Mathilde, Lin, Jenny, Fang, Xinping, Shah, Santosh, Garofolo, Wei, Kar, Sumit, Hayes, Roger, Pirro, John, Kane, Cheikh, Luna, Marsha, Xu, Allan, Cape, Stephanie, O'Dell, Mark, Wheller, Robert, Ritzen, Hanna, Vance, Jennifer, Farley, Esme, Matys, Katie, Tabler, Edward, Mylott, William, Yuan, Moucun, Karnik, Shane, Voelker, Troy, DuBey, Ira, Williard, Clark, Shi, Jing, Yamashita, Jim
Published in Bioanalysis (01.06.2022)
Published in Bioanalysis (01.06.2022)
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Recommendations on ELISpot assay validation by the GCC
Islam, Rafiq, Vance, Jennifer, Poirier, Martin, Zimmer, Jennifer, Khadang, Ardeshir, Williams, Dave, Zemo, Jennifer, Lester, Todd, Fjording, Marianne, Hays, Amanda, Hughes, Nicola, Garofolo, Fabio, Sheldon, Curtis, Guilbaud, Rudolf, Satterwhite, Christina, Colletti, Kelly, Groeber, Elizabeth, Renfrew, Heidi, Yu, Mathilde, Lin, Jenny, Fang, Xinping, Wissel, Mark, Beadnell, Thomas, Lin, John, Shah, Santosh, Garofolo, Wei, Savoie, Natasha, Hayes, Roger, Pirro, John, Kane, Cheikh, Luna, Marsha, Xu, Allan, Cape, Stephanie, O'Dell, Mark, Wheller, Robert, Ritzen, Hanna, Farley, Esme, Kierstead, Lisa, Mylott, William, Tabler, Edward, Yuan, Moucun, Karnik, Shane, Voelker, Troy, DuBey, Ira, Williard, Clark, Dong, Kelly, Shi, Jing, Yamashita, Jim
Published in Bioanalysis (01.02.2022)
Published in Bioanalysis (01.02.2022)
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Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis
Bower, Joseph, Zimmer, Jennifer, McCown, Stacie, Tabler, Edward, Karnik, Shane, Kar, Sumit, Sales, Kurt, Vance, Jennifer, Barry, Colin, Keyhani, Anahita, Williams, Dave, Lester, Todd, Garofolo, Fabio, Satterwhite, Christina, Groeber, Elizabeth, Renfrew, Heidi, Lin, Jenny, Cape, Stephanie, O'Dell, Mark, Fang, Xinping, Brant, Ashley, Garofolo, Wei, Savoie, Natasha, Hayes, Roger, Simchik, Sarah, Sun, Rachel, Bravo, Orlando, Dufield, Dawn, Luna, Marsha, Xu, Allan, Kane, Cheikh, Farley, Esme, Sanghvi, Mitesh, Hays, Amanda, Lowes, Steve, Islam, Rafiq, Hoffpauir, Brian, Beaver, Chris, Dong, Kelly, Desai-Krieger, Daksha
Published in Bioanalysis (01.04.2021)
Published in Bioanalysis (01.04.2021)
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GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
Nehls, Corey, Buonarati, Michael, Cape, Stephanie, Islam, Rafiq, Satterwhite, Christina, Briscoe, Chad, Hayes, Roger, Dinan, Andrew, Sales, Kurt, Anderson, Shelby, Vance, Jennifer, Lindsay, John, Zimmer, Jennifer, Couerbe, Philippe, Khadang, Ardeshir, Maasjo, Sarah, Bravo, Orlando, Lindley, Kathie, Moran, Liam, Sangster, Timothy, Vija, Jenifer, Stamatopoulos, John, Lin, Jenny, Reuschel, Scott, Underberg, Angie, MacNeill, Robert, Matassa, Luca, Spytko, Adriane, Garofolo, Wei, Savoie, Natasha, Rhyne, Paul, Ambrosius, Jason, Barra, Valentine, Dufield, Dawn, Luna, Marsha, Spriggs, Franklin, Fedorov, Evgueni, Ritzén, Hanna, Fatmi, Saadya, Kane, Cheikh, Bouhajib, Mohammed, DiMarco, Chantal, Iordachescu, Adriana, Tudoroniu, Ariana, Farley, Esme, Stouffer, Bruce, Tabler, Edward, McCown, Stacie, Bower, Joseph, Harrison, Travis, Karnik, Shane, Brown, Michael, Joyce, Philip, DuBey, Ira, Hoffpauir, Brian, Boudreau, Nadine, Bergeron, Jerome, Wang, Hao, Feng, Hao, Zhou, Shaolian, Wells, Edward, Pirro, John, Fang, Xinping, Shi, Jing, Yang, Changming
Published in Bioanalysis (01.09.2019)
Published in Bioanalysis (01.09.2019)
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