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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Journal Article
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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Journal Article