The development of methodology for clinical measurement of 5-lipoxygenase pathway intermediates from human peripheral blood mononuclear cells
Willey, Mark B., Alborn, William E., Lutzke, Barry S., LeLacheur, Richard M., White, Robert J., Stavrakis, George, Konrad, Robert J., Ackermann, Bradley L.
Published in Journal of pharmaceutical and biomedical analysis (15.12.2008)
Published in Journal of pharmaceutical and biomedical analysis (15.12.2008)
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Simultaneous quantification of atomoxetine as well as its primary oxidative and O-glucuronide metabolites in human plasma and urine using liquid chromatography tandem mass spectrometry (LC/MS/MS)
Mullen, John H., Shugert, Richard L., Ponsler, George D., Li, Qimin, Sundaram, Bhaskar, Coales, Heather L., Yakupkovic, Joseph E., LeLacheur, Richard M., Wheeler, William J., Belas, Frank J., Sauer, John-Michael
Published in Journal of pharmaceutical and biomedical analysis (15.07.2005)
Published in Journal of pharmaceutical and biomedical analysis (15.07.2005)
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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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Small Molecule Specific Run Acceptance, Specific Assay Operation, and Chromatographic Run Quality Assessment: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Teams
Woolf, Eric J., McDougall, Stuart, Fast, Douglas M., Andraus, Maristela, Barfield, Matthew, Blackburn, Michael, Gordon, Ben, Hoffman, David, Inoue, Noriko, Marcelin-Jimenez, Gabriel, Flynn, Amy, LeLacheur, Richard, Reuschel, Scott, Santhanam, Ravisankar, Bennett, Patrick, Duncan, Barbara, Hayes, Roger, Lausecker, Berthold, Sharma, Abhishek, Togashi, Kazutaka, Trivedi, Ravi Kumar, Vago, Miguel, White, Stephen, Barton, Hollie, Dunn, John A., Farmen, Raymond H., Heinig, Katja, Holliman, Christopher, Komaba, Junji, Riccio, Maria Francesca, Thomas, Elizabeth
Published in The AAPS journal (01.09.2014)
Published in The AAPS journal (01.09.2014)
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Journal Article
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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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
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 Cruz, Khadang, Ardeshir, Bourdage, James, Hughes, Nicola, Fatmi, Saadya, Di Donato, Lorella, Sheldon, Curtis, Keyhani, Anahita, Satterwhite, Christina, Yu, Mathilde, Fiscella, Michele, Hulse, James, Lin, Zhongping John, Garofolo, Wei, Savoie, Natasha, Xiao, Yi Qun, Kurylak, Kai, Harris, Sarah, Saxena, Manju, Buonarati, Mike, Lévesque, Ann, Boudreau, Nadine, Lin, Jenny, Khan, Masood U, Ray, Gene, Liu, Yansheng, Xu, Allan, Soni, Gunjan, Ward, Ian, Kingsley, Clare, Ritzén, Hanna, Tabler, Edward, Nicholson, Bob, Bennett, Patrick, van de Merbel, Nico, Karnik, Shane, Bouhajib, Mohammed, Wieling, Jaap, Mulvana, Daniel, Ingelse, Benno, Allen, Mike, Malone, Michele, Fang, Xinping
Published in Bioanalysis (01.03.2016)
Published in Bioanalysis (01.03.2016)
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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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Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
Nicholson, Robert, Lowes, Steve, Caturla, Maria Cruz, Safavi, Afshin, Mamelak, Dan, Islam, Rafiq, Allinson, John, Gouty, Dominique, Khan, Masood, Lelacheur, Richard, Shoup, Ronald, Martinez, Suzanne, Dumont, Isabelle, Zimmer, Jennifer, Steffen, Ray, Petrilla, James, Awaiye, Kayode, Sheldon, Curtis, Turk, Douglas, Fast, Douglas, Kamerud, John, Dinan, Andrew, Lin, Zhongping John, Garofolo, Wei, Tang, Daniel, Wright, Laura, Lin, Jenny, Yamashita, Yasuhiro, Liu, Yansheng, Xu, Allan, Hayes, Roger, Bouhajib, Mohammed, Levesque, Ann, Gagnon-Carignan, Sofi, Harman, Jake, Warren, Mark, Karnik, Shane, Cojocaru, Laura, Reuschel, Scott, Gonzalez, Pilar, Fatmi, Saadya, Vija, Jenifer, Rock, Marie, Malone, Michele, Nowatzke, William, Fang, Xinping
Published in Bioanalysis (01.10.2012)
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Published in Bioanalysis (01.10.2012)
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