The Decennial Index of The White Papers in Bioanalysis:  ‘A Decade of Recommendations (2007–2016)’ von Garofolo, Wei, Savoie, Natasha

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Looking Beyond the Wrib Decennial Index of the White Papers in Bioanalysis von Garofolo, Wei, Savoie, Natasha

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The Decennial Index of the White Papers in Bioanalysis von Garofolo, Wei, Savoie, Natasha

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Recommendations on qPCR/ddPCR assay validation by GCC von 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

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Recommendations on ELISpot assay validation by the GCC von 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

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Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis von 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

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GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline von 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

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Recommendations on Incurred Sample Stability (ISS) by GCC von 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

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12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity von Briscoe, Chad, Hughes, Nicola, Hayes, Roger, Islam, Rafiq, Bennett, Patrick, Stouffer, Bruce, Cape, Stephanie, Rhyne, Paul, Beaver, Chris, St Charles, Jessica, 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, Di Marco, Chantal, 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

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Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis von Islam, Rafiq, Kar, Sumit, Ritzén, Hanna, Hays, Amanda, Tayyem, Rabab, Barry, Colin, Keyhani, Anahita, Zimmer, Jennifer, Cruz Caturla, Maria, 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, St Charles, Jessica, Bouhajib, Mohammed, DiMarco, Chantal, DiMarco, 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

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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 valid... von 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

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7th GCC Insights: Incurred Samples Use; Fit-For-Purpose Validation, Solution Stability, Electronic Laboratory Notebook and Hyperlipidemic Matrix Testing von 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

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The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and co... von Cape, Stephanie, Islam, Rafiq, Nehls, Corey, Allinson, John, Safavi, Afshin, Bennett, Patrick, Hulse, James, Beaver, Chris, Khan, Masood, Karnik, Shane, Caturla, Maria Cruz, Lowes, Steve, Iordachescu, Adriana, Silvestro, Luigi, Tayyem, Rabab, Shoup, Ron, Mowery, Stephanie, Keyhani, Anahita, Wakefield, Andrea, Li, Yinghe, Zimmer, Jennifer, Torres, Javier, Couerbe, Philippe, Khadang, Ardeshir, Bourdage, James, Hughes, Nicola, Awaiye, Kayode, Matthews, Brent, Fatmi, Saadya, Johnson, Rhonda, Satterwhite, Christina, Yu, Mathilde, Lin, Jenny, Cojocaru, Laura, Fiscella, Michele, Thomas, Eric, Kurylak, Kai, Kamerud, John, Lin, Zhongping (John), Garofolo, Wei, Savoie, Natasha, Buonarati, Mike, Boudreau, Nadine, Williard, Clark, Liu, Yansheng, Warrino, Dominic, Kale, Prashant, Adcock, Neil, Shekar, Radha, O'Connor, Edward, Ritzen, Hanna, Sanchez, Christina, Hayes, Roger, Bouhajib, Mohammed, Savu, Simona Rizea, Stouffer, Bruce, Tabler, Edward, Tu, Jing, Briscoe, Chad, der Strate, Barry van, Rhyne, Paul, Conliffe, Phyllis, DuBey, Ira, Yamashita, Jim, Tang, Daniel, Groeber, Elizabeth, Vija, Jenifer, Malone, Michele, Osman, Mohamed

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8th GCC: Consolidated Feedback to US FDA on The 2013 Draft FDA Guidance on Bioanalytical Method Validation von 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

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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 E... von 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

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2017 White Paper on Recent Issues in Bioanalysis: Rise of Hybrid LBA/LCMS Immunogenicity Assays (Part 2: Hybrid LBA/LCMS Biotherapeutics, Biomarkers & Immunogenicity Assays and Reg... von Neubert, Hendrik, Song, An, Lee, Anita, Wei, Cong, Duggan, Jeff, Xu, Keyang, Woolf, Eric, Evans, Chris, Palandra, Joe, Laterza, Omar, Amur, Shashi, Berger, Isabella, Bustard, Mark, Cancilla, Mark, Chen, Shang-Chiung, Cho, Seongeun (Julia), Ciccimaro, Eugene, Cludts, Isabelle, Cocea, Laurent, D’Arienzo, Celia, Danan-Leon, Lieza, Donato, Lorella Di, Garofolo, Fabio, Haidar, Sam, Ishii-Watabe, Akiko, Jiang, Hao, Kadavil, John, Kassim, Sean, Kurki, Pekka, Blaye, Olivier Le, Liu, Kai, Mathews, Rod, Lima Santos, Gustavo Mendes, Niwa, Makoto, Pedras-Vasconcelos, João, Qian, Mark, Rago, Brian, Saad, Ola, Saito, Yoshiro, Savoie, Natasha, Su, Dian, Szapacs, Matthew, Tampal, Nilufer, Vinter, Stephen, Wang, Jian, Welink, Jan, Whale, Emma, Wilson, Amanda, Xue, Y-J

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2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs) von Neubert, Hendrik, Song, An, Lee, Anita, Wei, Cong, Duggan, Jeff, Xu, Keyang, Woolf, Eric, Evans, Chris, Palandra, Joe, Laterza, Omar, Amur, Shashi, Berger, Isabella, Bustard, Mark, Cancilla, Mark, Chen, Shang-Chiung, Cho, Seongeun (Julia), Ciccimaro, Eugene, Cludts, Isabelle, Cocea, Laurent, D'Arienzo, Celia, Danan-Leon, Lieza, Donato, Lorella Di, Garofolo, Fabio, Haidar, Sam, Ishii-Watabe, Akiko, Jiang, Hao, Kadavil, John, Kassim, Sean, Kurki, Pekka, Blaye, Olivier Le, Liu, Kai, Mathews, Rod, Lima Santos, Gustavo Mendes, Niwa, Makoto, Pedras-Vasconcelos, João, Qian, Mark, Rago, Brian, Saad, Ola, Saito, Yoshiro, Savoie, Natasha, Su, Dian, Szapacs, Matthew, Tampal, Nilufer, Vinter, Stephen, Wang, Jian, Welink, Jan, Whale, Emma, Wilson, Amanda, Xue, Y-J

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Speaker Tracking in Seminars by Human Body Detection von Wu, Bo, Singh, Vivek Kumar, Nevatia, Ram, Chu, Chi-Wei

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