Planning Split-Apheresis Designs for Demonstrating Comparability of Cellular and Gene Therapy Products von Burdick, Richard, Hofer, Jeff, Karl, Andrew, Rushing, Heath

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Analytical approaches to ensure product quality -- AAPS Joint Face-to-Face Meeting of the Stability, the Pharmaceutical Impurities, and the CMC Statistics Focus Groups, April 6th,... von Huynh-Ba, Kim, Larner, Greg, Strickland, Helen, Choudhury, Dilip, Wu, Yan, Hofer, Jeff, Wang, Zhenyu, Schofield, Timothy

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Analytical method comparability in registration and post-approval stages: a risk-based approach: a risk-based approach is recommended for analytical method comparability for HPLC a... von Abdel-Kader, Hafez, Argentine, Mark, Hofer, Jeff, Benz, Nancy, Burdick, Rick, Chatfield, Marion, Diana, Frank, Fang, Hui, Huang, Yuan, Karmarkar, Shreekant, Nair, Lakshmy M, Natishan, Theresa, Pless, Andrea M, Wang, Qinggang, Williams, Zeena

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Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach von Abdel-Kader, Hafez, Argentine, Mark, Hofer, Jeff, Benz, Nancy, Burdick, Rick, Chatfield, Marion, Diana, Frank, Fang, Hui, Huang, Yuan, Karmarkar, Shreekant, Nair, Lakshmy M, Natishan, Theresa, Pless, Andrea M, Wang, Qinggang, Williams, Zeena

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Development of a Content Uniformity Test Suitable for Large Sample Sizes von Sandell, Dennis, Vukovinsky, Kim, Diener, Myron, Hofer, Jeff, Pazdan, James, Timmermans, Joep

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Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach von Abdel-Kader, Hafez, Argentine, Mark, Benz, Nancy, Burdick, Rick, Chatfield, Marion, Diana, Frank, Fang, Hui, Hofer, Jeff, Huang, Yuan, Karmarkar, Shreekant, Nair, Lakshmy M, Natishan, Theresa, Pless, Andrea M, Wang, Qinggang, Williams, Zeena

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Overcoming disincentives to process understanding in the pharmaceutical CMC environment von Foust, Laura, Diener, Myron, Gorko, Mary Ann, Hofer, Jeff, Larner, Greg, LeBlond, David, Lewis, Jerry, Sandell, Dennis, Schofield, Tim, Vukovinsky, Kim, Warner, Ed

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Analytical method comparability in registration and post-approval stages: a risk-based approach: a risk-based approach is recommended for analytical method comparability for HPLC a... von Abdel-Kader, Hafez, Argentine, Mark, Benz, Nancy, Burdick, Rick, Chatfield, Marion, Diana, Frank, Fang, Hui, Hofer, Jeff, Huang, Yuan, Karmarkar, Shreekant, Nair, Lakshmy M, Natishan, Theresa, Pless, Andrea M, Wang, Qinggang, Williams, Zeena

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Fontan-Associated Liver Disease: Screening, Management, and Transplant Considerations von Emamaullee, Juliet, Zaidi, Ali N., Schiano, Thomas, Kahn, Jeffrey, Valentino, Pamela L., Hofer, Ryan E., Taner, Timucin, Wald, Joyce W., Olthoff, Kim M., Bucuvalas, John, Fischer, Ryan

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Adjunctive Azithromycin Prophylaxis for Cesarean Delivery von Tita, Alan T.N, Szychowski, Jeff M, Boggess, Kim, Saade, George, Longo, Sherri, Clark, Erin, Esplin, Sean, Cleary, Kirsten, Wapner, Ron, Letson, Kellett, Owens, Michelle, Abramovici, Adi, Ambalavanan, Namasivayam, Cutter, Gary, Andrews, William

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Characterization of TMPRSS2-ERG Fusion High-Grade Prostatic Intraepithelial Neoplasia and Potential Clinical Implications von MOSQUERA, Juan-Miguel, PERNER, Sven, SHAH, Rajal B, LODA, Massimo, RUBIN, Mark A, GENEGA, Elizabeth M, SANDA, Martin, HOFER, Matthias D, MERTZ, Kirsten D, PARIS, Pamela L, SIMKO, Jeff, BISMAR, Tarek A, AYALA, Gustavo

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Preoperative Computed Tomographic Angiogram Measurement of Abdominal Muscles Is a Valuable Risk Assessment for Bulge Formation after Microsurgical Abdominal Free Flap Breast Recons... von Kappos, Elisabeth A., Jaskolka, Jeff, Butler, Kate, O’Neill, Anne C., Hofer, Stefan O. P., Zhong, Toni

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TMPRSS2-ERG fusion Prostate cancer: An early molecular event associated with invasion von PERNER, Sven, MASQUERA, Juan-Miguel, RUBIN, Mark A, DEMICHELIS, Francesca, HOFER, Matthias D, PARIS, Pamela L, SIMKO, Jeff, COLLINS, Colin, BISMAR, Tarek A, CHINNAIYAN, Arul M, DE MARZO, Angelo M

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Are physicians aware of which of their patients have indwelling urinary catheters? von Saint, Sanjay, Wiese, Jeff, Amory, John K, Bernstein, Michael L, Patel, Uptal D, Zemencuk, Judith K, Bernstein, Steven J, Lipsky, Benjamin A, Hofer, Timothy P

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Incidentalomas associated with abdominal and pelvic CT angiograms for abdominal-based breast free flap reconstruction von Ho, Olivia A, Bagher, Shaghayegh, Jaskolka, Jeff, Tan, Marcus, Butler, Kate, O'Neill, Anne C, Zhong, Toni, Hofer, Stefan O

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Defining Aggressive Prostate Cancer Using a 12-Gene Model von Bismar, Tarek A., Demichelis, Francesca, Riva, Alberto, Kim, Robert, Varambally, Sooryanarayana, He, Le, Kutok, Jeff, Aster, Jonathan C., Tang, Jeffery, Kuefer, Rainer, Hofer, Matthias D., Febbo, Phillip G., Chinnaiyan, Arul M., Rubin, Mark A.

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Epidemiology of readmissions in early infancy following nonelective cesarean delivery von Ambalavanan, Namasivayam, Jauk, Victoria, Szychowski, Jeff M., Boggess, Kim A., Saade, George, Longo, Sherri, Esplin, Sean, Cleary, Kirsten, Wapner, Ronald, Letson, Kellett, Owens, Michelle, Blackwell, Sean, Andrews, William, Tita, Alan T.

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Genome Analyses of >200,000 Individuals Identify 58 Loci for Chronic Inflammation and Highlight Pathways that Link Inflammation and Complex Disorders von Ligthart, Symen, Vaez, Ahmad, Võsa, Urmo, Stathopoulou, Maria, de Vries, Paul, Prins, Bram, van der Most, Peter, Tanaka, Toshiko, Naderi, Elnaz, Rose, Lynda, Wu, Ying, Karlsson, Robert, Barbalic, Maja, Lin, Honghuang, Pool, René, Zhu, Gu, Macé, Aurélien, Sidore, Carlo, Trompet, Stella, Mangino, Massimo, Sabater-Lleal, Maria, Kemp, John, Abbasi, Ali, Kacprowski, Tim, Verweij, Niek, Smith, Albert, Huang, Tao, Marzi, Carola, Feitosa, Mary, Lohman, Kurt, Kleber, Marcus, Milaneschi, Yuri, Mueller, Christian, Huq, Mahmudul, Vlachopoulou, Efthymia, Lyytikäinen, Leo-Pekka, Oldmeadow, Christopher, Deelen, Joris, Perola, Markus, Zhao, Jing Hua, Feenstra, Bjarke, Amini, Marzyeh, Lahti, Jari, Schraut, Katharina, Fornage, Myriam, Suktitipat, Bhoom, Chen, Wei-Min, Li, Xiaohui, Nutile, Teresa, Malerba, Giovanni, Luan, Jian’an, Bak, Tom, Schork, Nicholas, del Greco M., Fabiola, Thiering, Elisabeth, Mahajan, Anubha, Marioni, Riccardo, Mihailov, Evelin, Eriksson, Joel, Ozel, Ayse Bilge, Zhang, Weihua, Nethander, Maria, Cheng, Yu-Ching, Aslibekyan, Stella, Ang, Wei, Gandin, Ilaria, Yengo, Loïc, Portas, Laura, Kooperberg, Charles, Hofer, Edith, Rajan, Kumar, Schurmann, Claudia, den Hollander, Wouter, Ahluwalia, Tarunveer, Zhao, Jing, Draisma, Harmen H.M., Ford, Ian, Timpson, Nicholas, Teumer, Alexander, Huang, Hongyan, Wahl, Simone, Liu, Yongmei, Huang, Jie, Uh, Hae-Won, Geller, Frank, Joshi, Peter, Yanek, Lisa, Trabetti, Elisabetta, Lehne, Benjamin, Vozzi, Diego, Verbanck, Marie, Biino, Ginevra, Saba, Yasaman, Meulenbelt, Ingrid, O’connell, Jeff, Laakso, Markku, Giulianini, Franco, Magnusson, Patrik K.E., Ballantyne, Christie, Hottenga, Jouke Jan

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Genome Analyses of >200,000 Individuals Identify 58 Loci for Chronic Inflammation and Highlight Pathways that Link Inflammation and Complex Disorders von Vaez, Ahmad, Stathopoulou, Maria G, Wu, Ying, Karlsson, Robert, Barbalic, Maja, Kacprowski, Tim, Smith, Albert V, Huang, Tao, Marzi, Carola, Feitosa, Mary F, Kleber, Marcus E, Milaneschi, Yuri, Mueller, Christian, Deelen, Joris, Amini, Marzyeh, Suktitipat, Bhoom, Nutile, Teresa, Thiering, Elisabeth, Mahajan, Anubha, Mihailov, Evelin, Zhang, Weihua, Aslibekyan, Stella, Ford, Ian, Timpson, Nicholas, Wahl, Simone, Liu, YongMei, Uh, Hae-Won, Trabetti, Elisabetta, Verbanck, Marie, Biino, Ginevra, Ballantyne, Christie M, Rivadineira, Fernando, Stott, David J, Vaidya, Dhananjay, Delgado, Graciela, Großmann, Vera, Sinisalo, Juha, Seppälä, Ilkka, Williams, Stephen R, Moed, Matthijs, Räikkönen, Katri, Campbell, Harry, Chen, Yii-Der I, Ruggiero, Daniela, Smith, Erin N, Berenson, Gerald S, Hernandez, Dena, Tiesler, Carla M T, Liewald, David, Mellström, Dan, Scott, William R, Lorentzon, Matthias, Concas, Maria Pina, Paternoster, Lavinia, Kähönen, Mika, Zoledziewska, Magdalena, Clarke, Robert, Harris, Tamara B, Attia, John R, van Heemst, Diana, Kajantie, Eero, Sorice, Rossella, Gambaro, Giovanni, Lindgren, Cecilia M, Lind, Lars, Chambers, John C, Meitinger, Thomas, Mohlke, Karen L, Pedersen, Nancy L, Boomsma, Dorret I, Vollenweider, Peter, Spector, Tim D, Borecki, Ingrid B, Melbye, Mads, Eriksson, Johan G, Wilson, James F, Becker, Diane M, Gibson, Greg, Ciullo, Marina, Oldehinkel, Albertine J, Palmer, Lyle J, Murray, Sarah S, Pramstaller, Peter P, Mägi, Reedik, Vandenput, Liesbeth, Desch, Karl C, Ohlsson, Claes, Hayward, Caroline, Robino, Antonietta, Pirastu, Mario, Koenig, Wolfgang, Loos, Ruth J F, Smith, George Davey, Tracy, Russell P, Boerwinkle, Eric, Reiner, Alex P, Gross, Myron, Dupuis, Josée, Snieder, Harold, Alizadeh, Behrooz Z

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The database of the PREDICTS (Projecting Responses of Ecological Diversity In Changing Terrestrial Systems) project von Hudson, Lawrence N., Bedford, Felicity E., Bennett, Dominic J., Pan, Yuan, Pask‐Hale, Gwilym D., Sanchez‐Ortiz, Katia, Zhang, Hanbin, Adum, Gilbert B., Aguilar‐Barquero, Virginia, Albertos, Belén, Alignier, Audrey, Arbeláez‐Cortés, Enrique, Axmacher, Jan C., Banks, John E., Barlow, Jos, Bayne, Erin M., Beja, Pedro, Bicknell, Jake E., Bóçon, Roberto, Boekhout, Teun, Boutin, Céline, Calviño‐Cancela, María, Caparrós, Rut, Chapman, Kim Alan, Chauvat, Matthieu, Connop, Stuart P., Craig, Michael D., Domínguez, Erwin, Dreber, Niels, Dumont, Bertrand, Dynesius, Mats, Farwig, Nina, Fensham, Roderick J., Fırıncıoğlu, Hüseyin K., Fredriksson, Gabriella M., Gaigher, René, Ge, Bao‐Ming, Gheler‐Costa, Carla, Gilbert, Benjamin, Giordani, Paolo, Goulson, Dave, Gray, Claudia L., Gunawardene, Nihara R., Gutiérrez‐Lamus, Doris L., Hanson, Thor, Henschel, Philipp, Ishitani, Masahiro, Jacobs, Carmen T., Johnson, McKenzie F., Jonsell, Mats, Juliani, S. Nur, Kapoor, Vena, Kati, Vassiliki, Kirby, Kathryn R., Koivula, Matti, Kone, Mouhamadou, Kutt, Alex S., Lachat, Thibault, Lantschner, Victoria, Lucas‐Borja, Manuel Esteban, MacSwiney G, M Cristina, Mallari, Neil Aldrin, Marin‐Spiotta, Erika, Marshall, E. J. P., Martínez, Eliana, Mayfield, Margaret M., Mazimpaka, Vicente, McCarthy, Kyle P., Morales, Carolina L., Munira, A. Nur, Navarro‐Iriarte, Luis, Nilsson, Sven G., Numa, Catherine, Peri, Pablo L., Persson, Anna S., Pethiyagoda, Rohan S., Poggio, Santiago L., Poveda, Katja, Power, Eileen F., Ramirez‐Pinilla, Martha P., Rös, Matthias, Roth, Dana S., Roulston, T'ai H., Rubio, André V., Ruel, Jean‐Claude, Saldaña‐Vázquez, Romeo A., Sam, Katerina, Santana, Joana, Savage, Jade, Simonetti, Javier A., Smith‐Pardo, Allan H., Stefanescu, Constanti, Tonietto, Rebecca K., Vallan, Denis, Verdasca, Maria João, Virgilio, Massimiliano, Williams, Christopher D., Willig, Michael R., Wolf, Jan H. D., Mace, Georgina M.

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