Characterization of a partial-body irradiation model with oral cavity shielding in nonhuman primates
Accardi, Michael V., Donini, Oreola, Rumage, Adam, Ascah, Alexis, Haruna, Julius, Pouliot, Mylène, Bujold, Kim, Huang, Hai, Wierzbicki, Wieslaw, Stamatopoulos, John, Naraghi, Houman, Measey, Thomas, Authier, Simon
Published in International journal of radiation biology (02.01.2020)
Published in International journal of radiation biology (02.01.2020)
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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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12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity
Briscoe, Chad, Hughes, Nicola, Hayes, Roger, Islam, Rafiq, Bennett, Patrick, Stouffer, Bruce, Cape, Stephanie, Rhyne, Paul, Beaver, Chris, Charles, Jessica St, Kakkanaiah, Vellalore, Xu, Allan, Caturla, Maria Cruz, Spriggs, Franklin, Tayyem, Rabab, Barry, Colin, Keyhani, Anahita, Zimmer, Jennifer, Couerbe, Philippe, Warren, Mark, Khadang, Ardeshir, Bourdage, James, Lindley, Kathie, Williams, Dave, Sheldon, Curtis, Satterwhite, Christina, Vija, Jenifer, Yu, Mathilde, Boulay, Iohann, Stamatopoulos, John, Lin, Jenny, Estdale, Sian, Thomas, Eric, Dinan, Andrew, MacNeill, Robert, Xiao, Yi Qun, Matassa, Luca, Garofolo, Wei, Savoie, Natasha, Hristopoulos, George, Xu, Arron, Goodwin, Lawrence, Awaiye, Kayode, Ritzén, Hanna, Bouhajib, Mohammed, Marco, Chantal Di, Savu, Simona Rizea, Nehls, Corey, Tabler, Edward, Hays, Amanda, Karnik, Shane, Brown, Michael, Lowes, Steve, DuBey, Ira, Kulagina, Nadia, Lindsay, John, Williard, Clark, Wang, Hao, Malone, Michele, Wells, Edward, Fang, Xinping, Moussallie, Marc
Published in Bioanalysis (01.06.2019)
Published in Bioanalysis (01.06.2019)
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Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis
Islam, Rafiq, Kar, Sumit, Ritzén, Hanna, Hays, Amanda, Tayyem, Rabab, Barry, Colin, Keyhani, Anahita, Zimmer, Jennifer, Caturla, Maria Cruz, Couerbe, Philippe, Warren, Mark, Khadang, Ardeshir, Bourdage, James, Lindley, Kathie, Williams, Dave, Hughes, Nicola, Sheldon, Curtis, Satterwhite, Christina, Vija, Jenifer, Yu, Mathilde, Boulay, Iohann, Stamatopoulos, John, Lin, Jenny, Cape, Stephanie, Estdale, Sian, Thomas, Eric, Dinan, Andrew, MacNeill, Robert, Xiao, Yi Qun, Garofolo, Wei, Savoie, Natasha, Brown, Michael, Rhyne, Paul, Hristopoulos, George, Xu, Arron, Goodwin, Lawrence, Spriggs, Franklin, Xu, Allan, Awaiye, Kayode, Hayes, Roger, Charles, Jessica St, Bouhajib, Mohammed, Silvestro, Luigi, Savu, Simona Rizea, Bennett, Patrick, Kakkanaiah, Vellalore, Nehls, Corey, Stouffer, Bruce, Tabler, Edward, Briscoe, Chad, Karnik, Shane, DuBey, Ira, Kulagina, Nadia, Lindsay, John, Beaver, Chris, Williard, Clark, Wang, Hao, Feng, Hao, Malone, Michele, Wells, Edward, Fang, Xinping, Moussallie, Marc
Published in Bioanalysis (01.04.2019)
Published in Bioanalysis (01.04.2019)
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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
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, Masood, Keyhani, Anahita, Zimmer, Jennifer, Caturla, Maria Cruz, Couerbe, Philippe, Khadang, Ardeshir, Bourdage, James, Datin, Jim, Zemo, Jennifer, Hughes, Nicola, Fatmi, Saadya, Sheldon, Curtis, Fountain, Scott, Satterwhite, Christina, Colletti, Kelly, Vija, Jenifer, Yu, Mathilde, Stamatopoulos, John, Lin, Jenny, Wilfahrt, Jim, Dinan, Andrew, Ohorodnik, Susan, Hulse, James, Patel, Vimal, Garofolo, Wei, Savoie, Natasha, Brown, Michael, Papac, Damon, Buonarati, Mike, Hristopoulos, George, Beaver, Chris, Boudreau, Nadine, Williard, Clark, Liu, Yansheng, Ray, Gene, Warrino, Dominic, Xu, Allan, Green, Rachel, Hayward-Sewell, Joanne, Marcelletti, John, Sanchez, Christina, Kennedy, Michael, Charles, Jessica St, Bouhajib, Mohammed, Nehls, Corey, Tabler, Edward, Tu, Jing, Joyce, Philip, Iordachescu, Adriana, DuBey, Ira, Lindsay, John, Yamashita, Jim, Wells, Edward
Published in Bioanalysis (01.04.2018)
Published in Bioanalysis (01.04.2018)
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Journal Article
Formation of a Global Contract Research Organization Council for Bioanalysis
Premkumar, Noel, Lowes, Stephen, Jersey, James, Garofolo, Fabio, Dumont, Isabelle, Masse, Robert, Stamatiou, Betty, Caturla, Maria C, Steffen, Ray, Malone, Michele, Offman, Elliot, Samuels, Timothy, Oldfield, Phillip, Di Donato, Lorella, Fast, Douglas, Tang, Daniel, Moussallie, Marc, Doughty, John, Rocci, Mario, Buonarati, Mike, Gouty, Dominique, Dadgar, Darioush, Stamatopoulos, John, Breau, Alan, Ntsikoussalabongui, Bernard, Bouhajib, Mohammed, Nicholson, Bob, Tacey, Richard, Ketelaar, Peter, Briscoe, Chad, Karnik, Shane, Wieling, Jaap, Smith, Jon Kirk, Reid, Michael J, Lelacheur, Richard, Chapdelaine, John, Fatmi, Saadya, Sayyarpour, Farhad, Fang, Xinping, Cook, Jeremy, Browne, David
Published in Bioanalysis (01.11.2010)
Published in Bioanalysis (01.11.2010)
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Journal Article
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
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, Masood, Keyhani, Anahita, Zimmer, Jennifer, Caturla, Maria Cruz, Couerbe, Philippe, Khadang, Ardeshir, Bourdage, James, Datin, Jim, Zemo, Jennifer, Hughes, Nicola, Fatmi, Saadya, Sheldon, Curtis, Fountain, Scott, Satterwhite, Christina, Colletti, Kelly, Vija, Jenifer, Yu, Mathilde, Stamatopoulos, John, Lin, Jenny, Wilfahrt, Jim, Dinan, Andrew, Ohorodnik, Susan, Hulse, James, Patel, Vimal, Garofolo, Wei, Savoie, Natasha, Brown, Michael, Papac, Damon, Buonarati, Mike, Hristopoulos, George, Beaver, Chris, Boudreau, Nadine, Williard, Clark, Liu, Yansheng, Ray, Gene, Warrino, Dominic, Xu, Allan, Green, Rachel, Hayward-Sewell, Joanne, Marcelletti, John, Sanchez, Christina, Kennedy, Michael, Charles, Jessica St, Bouhajib, Mohammed, Nehls, Corey, Tabler, Edward, Tu, Jing, Joyce, Philip, Iordachescu, Adriana, DuBey, Ira, Lindsay, John, Yamashita, Jim, Wells, Edward
Published in Bioanalysis (01.04.2018)
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Published in Bioanalysis (01.04.2018)
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