GlycoPEGylation of recombinant therapeutic proteins produced in Escherichia coli
DeFrees, Shawn, Wang, Zhi-Guang, Xing, Ruye, Scott, Arthur E, Wang, Jin, Zopf, David, Gouty, Dominique L, Sjoberg, Eric R, Panneerselvam, Krishnasamy, Brinkman-Van der Linden, Els C.M, Bayer, Robert J, Tarp, Mads A, Clausen, Henrik
Published in Glycobiology (Oxford) (01.09.2006)
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Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments
Marini, Joseph C., Anderson, Michael, Cai, Xiao-Yan, Chappell, John, Coffey, Todd, Gouty, Dominique, Kasinath, Aparna, Koppenburg, Vera, Oldfield, Philip, Rebarchak, Shannon, Bowsher, Ronald R.
Published in The AAPS journal (01.11.2014)
Published in The AAPS journal (01.11.2014)
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2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections
Garofolo, Fabio, Rocci, Jr, Mario L, Dumont, Isabelle, Martinez, Suzanne, Lowes, Steve, Woolf, Eric, van Amsterdam, Peter, Bansal, Surendra, Barra, Ariadna Cristina Gomes, Bauer, Ronald, Booth, Brian P, Carrasco-Triguero, Montserrat, DeSilva, Binodh, Dunn, John, Gallicano, Keith, Gouty, Dominique, Ho, Stacy, Hucker, Richard, Jemal, Mohammed, Katori, Noriko, Le Blaye, Olivier, Lee, Jean, Li, Wenkui, Michael, Steve, Nehls, Corey, Nicholson, Robert, Ormsby, Eric, Tang, Daniel, Viswanathan, C T, Weiner, Russell, Young, Graeme
Published in Bioanalysis (01.09.2011)
Published in Bioanalysis (01.09.2011)
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2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines
DeSilva, Binodh, Garofolo, Fabio, Rocci, Mario, Martinez, Suzanne, Dumont, Isabelle, Landry, France, Dicaire, Catherine, Szekely-Klepser, Gabriella, Weiner, Russell, Arnold, Mark, Bansal, Surendra, Bateman, Kevin, Bauer, Ronald, Booth, Brian, Davis, Scott, Dudal, Sherri, Gouty, Dominique, Grundy, John, Haidar, Sam, Hayes, Roger, Jemal, Mohammed, Kaur, Surinder, Kelley, Marian, Knutsson, Magnus, Le Blaye, Olivier, Lee, Jean, Lowes, Steve, Ma, Mark, Mitsuoka, Toshinari, Neto, João Tavares, Nicholson, Robert, Ormsby, Eric, Sailstad, Jeffrey, Stevenson, Lauren, Tang, Daniel, Welink, Jan, Viswanathan, C T, Wang, Laixin, Woolf, Eric, Yang, Eric
Published in Bioanalysis (01.09.2012)
Published in Bioanalysis (01.09.2012)
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2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS
Stevenson, Lauren, Garofolo, Fabio, DeSilva, Binodh, Dumont, Isabelle, Martinez, Suzanne, Rocci, Mario, Amaravadi, Lakshmi, Brudny-Kloeppel, Margarete, Musuku, Adrien, Booth, Brian, Dicaire, Catherine, Wright, Laura, Mayrand-Provencher, Laurence, Losauro, Mike, Gouty, Dominique, Arnold, Mark, Bansal, Surendra, Dudal, Sherri, Dufield, Dawn, Duggan, Jeff, Evans, Christopher, Fluhler, Eric, Fraser, Stephanie, Gorovits, Boris, Haidar, Sam, Hayes, Roger, Ho, Stacy, Houghton, Richard, Islam, Rafiqul, Jenkins, Rand, Katori, Noriko, Kaur, Surinder, Kelley, Marian, Knutsson, Magnus, Lee, Jean, Liu, Hanlan, Lowes, Steve, Ma, Mark, Mikulskis, Alvydas, Myler, Heather, Nicholson, Bob, Olah, Timothy, Ormsby, Eric, Patel, Shefali, Pucci, Vincenzo, Ray, Chad, Schultz, Gary, Shih, Judy, Shoup, Ronald, Simon, Craig, Song, An, Neto, João Tavares, Theobald, Valerie, Thway, Theingi, Wakelin-Smith, Jason, Wang, Jian, Wang, Laixin, Welink, Jan, Whale, Emma, Woolf, Eric, Xu, Raymond
Published in Bioanalysis (01.12.2013)
Published in Bioanalysis (01.12.2013)
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Erratum to: Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments
Marini, Joseph C., Anderson, Michael, Cai, Xiao-Yan, Chappell, John, Coffey, Todd, Gouty, Dominique, Kasinath, Aparna, Koppenburg, Vera, Oldfield, Philip, Rebarchak, Shannon, Bowsher, Ronald R.
Published in The AAPS journal (01.05.2017)
Published in The AAPS journal (01.05.2017)
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Recommendations on biomarker bioanalytical method validation by GCC
Hougton, Richard, Gouty, Dominique, Allinson, John, Green, Rachel, Losauro, Mike, Lowes, Steve, LeLacheur, Richard, Garofolo, Fabio, Couerbe, Philippe, Bronner, Stéphane, Struwe, Petra, Schiebl, Christine, Sangster, Timothy, Pattison, Colin, Islam, Rafiq, Garofolo, Wei, Pawula, Maria, Buonarati, Mike, Hayes, Roger, Cameron, Mark, Nicholson, Robert, Harman, Jake, Wieling, Jaap, De Boer, Theo, Reuschel, Scott, Cojocaru, Laura, Harter, Tammy, Malone, Michele, Nowatzke, William
Published in Bioanalysis (01.10.2012)
Published in Bioanalysis (01.10.2012)
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2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity)
Stevenson, Lauren, Amaravadi, Lakshmi, Myler, Heather, Salazar-Fontana, Laura, Gorovits, Boris, Kirshner, Susan, Xue, Li, Garofolo, Fabio, Alley, Stephen C, Thway, Theingi, Joyce, Alison, Bansal, Surendra, Beaver, Chris, Bergeron, Annik, Cai, Xiao-Yan, Cojocaru, Laura, DeSilva, Binodh, Dumont, Isabelle, Fluhler, Eric, Fraser, Stephanie, Gouty, Dominique, Gupta, Swati, Haidar, Sam, Hayes, Roger, Ingelse, Benno, Ishii-Watabe, Akiko, Kaur, Surinder, King, Lindsay, Laterza, Omar, Leung, Sheldon, Lévesque, Ann, Ma, Mark, Petit-Frere, Corinne, Pillutla, Renuka, Rose, Mark, Schultz, Gary, Smeraglia, John, Swanson, Steven, Torri, Albert, Vazvaei, Faye, Wakelin-Smith, Jason, Wilson, Amanda, Woolf, Eric, Yang, Tong-Yuan
Published in Bioanalysis (01.12.2014)
Published in Bioanalysis (01.12.2014)
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Recommendations on incurred sample stability (ISS) by GCC
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, Jim, Kamerud, John, Zhang, Tee, Pasas-Farmer, Stephanie, Garofolo, Wei, Moussallie, Marc, Rocci, Mario, Allinson, John, Gouty, Dominique, Buonarati, Mike, Boudreau, Nadine, Pellerin, Brigitte, Lin, Jenny, Xu, Allan, Hayes, Roger, Bouhajib, Mohammed, Stipancic, Mary, Nicholson, Robert, Nehls, Corey, Warren, Mark, Karnik, Shane, Houghton, Richard, Stovold, Craig, Reuschel, Scott, Cojocaru, Laura, Marcelletti, John, Fang, Xinping, Smith, Ian, Watson, Andrea
Published in Bioanalysis (01.09.2014)
Published in Bioanalysis (01.09.2014)
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7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing
Rocci, Mario, Lowes, Steve, Shoup, Ronald, Garofolo, Fabio, Farmen, Raymond, Zhang, Tianyi, Allinson, John, Gouty, Dominique, Hayes, Roger, Nicholson, Robert, Houghton, Richard, Dumont, Isabelle, LeLacheur, Richard, Zimmer, Jennifer, Cruz Caturla, Maria, Couerbe, Philippe, Awaiye, Kayode, Fatmi, Saadya, Sheldon, Curtis, Bower, Joseph, Fiscella, Michelle, Fast, Douglas, Cape, Stephanie, Hulse, Jim, Kamerud, John, Pasas-Farmer, Stephanie, Garofolo, Wei, Moussallie, Marc, Buonarati, Mike, Boudreau, Nadine, Pellerin, Brigitte, Lin, Jenny, Xu, Allan, Bouhajib, Mohammed, Stipancic, Mary, Nehls, Corey, Warren, Mark, Karnik, Shane, Stovold, Craig, Reuschel, Scott, Cojocaru, Laura, Marcelletti, John, Fang, Xinping, Smith, Ian, Watson, Andrea
Published in Bioanalysis (01.10.2014)
Published in Bioanalysis (01.10.2014)
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8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation
Bower, Joseph, Fast, Douglas, Garofolo, Fabio, Gouty, Dominique, Hayes, Roger, Lowes, Steve, Nicholson, Robert, LeLacheur, Richard, Bravo, Jennifer, Shoup, Ronald, Dumont, Isabelle, Carbone, Mary, Zimmer, Jennifer, Ortuno, Jordi, Caturla, Maria Cruz, Datin, Jim, Lansing, Tim, Fatmi, Saadya, Struwe, Petra, Sheldon, Curtis, Islam, Rafiqul, Yu, Mathilde, Hulse, Jim, Kamerud, John, Lin, John, Doughty, John, Kurylak, Kai, Tang, Daniel, Buonarati, Mike, Blanchette, Alexandre, Levesque, Ann, Gagnon-Carignan, Sofi, Lin, Jenny, Ray, Gene, Liu, Yanseng, Khan, Masood, Xu, Allan, El-Sulayman, Gibran, DiMarco, Chantal, Bouhajib, Mohammed, Tacey, Dick, Jenkins, Rand, der Strate, Barry van, Briscoe, Chad, Karnik, Shane, Rhyne, Paul, Garofolo, Wei, Schultz, Gary, Roberts, Andrew, Redrup, Mike, DuBey, Ira, Conliffe, Phyllis, Pekol, Teri, Hantash, Jamil, Cojocaru, Laura, Allen, Mike, Reuschel, Scott, Watson, Andrea, Farrell, Colin, Groeber, Elizabeth, Malone, Michele, Nowatzke, William, Fang, Xinping
Published in Bioanalysis (01.01.2014)
Published in Bioanalysis (01.01.2014)
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Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
Lowes, Steve, Boterman, Mark, Doig, Mira, Breda, Massimo, Jersey, Jim, Lelacheur, Richard, Shoup, Ronald, Garofolo, Fabio, Dumont, Isabelle, Martinez, Suzanne, Needham, Shane, Zimmer, Jennifer, Caturla, Maria Cruz, Couerbe, Philippe, Maltas, John, Steffen, Ray, Petrilla, James, Safavi, Afshin, Awaiye, Kayode, Bhatti, Masood, Sheldon, Curtis, Schiebl, Christine, Struwe, Petra, Turk, Douglas, Sangster, Timothy, Pattison, Colin, Fast, Douglas, Goodwin, Lee, Kamerud, John, Dinan, Andrew, Mamelak, Dan, Islam, Rafiq, Segers, Rudi, Lin, Zhongping John, Hillier, Jim, Garofolo, Wei, Folguera, Lois, Zimmer, Dieter, Zimmermann, Thomas, Pawula, Maria, Moussallie, Marc, de Souza Teixeira, Leonardo, Rocha, Thais, Allinson, John, Jardieu, Paula, Tang, Daniel, Gouty, Dominique, Wright, Laura, Truog, James, Lin, Jenny, Yamashita, Yasuhiro, Khan, Masood, Liu, Yansheng, Xu, Allan, Lundberg, Richard, Cox, Chris, Breau, Alan, Hayes, Roger, Bigogno, Chiara, Schoutsen, Dick, Dilger, Carmen, Jonker, Jianine, Bouhajib, Mohammed, Levesque, Ann, Gagnon-Carignan, Sofi, Harman, Jake, Nicholson, Robert, Jenkins, Rand, Warren, Mark, Lin, Ming Hung, Karnik, Shane, De Boer, Theo, Houghton, Richard, Green, Rachel, Demaio, William, Sable, Romuald, Smith, Kirk, Siethoff, Christoph, Cojocaru, Laura, Allen, Mike, Reuschel, Scott, Gonzalez, Pilar, Harter, Tammy, Fatmi, Saadya, Rock, Marie, Vija, Jenifer, Sayyarpour, Farhad, Malone, Michele, Nowatzke, William, Best, Stuart, Fang, Xinping
Published in Bioanalysis (01.09.2012)
Published in Bioanalysis (01.09.2012)
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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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