Impact of genetically modified organism requirements on gene therapy development in the EU, Japan, and the US von Tajima, Gentaro, Huh, Seoan, Schmidt, Natalie Anne, Macdonald, Judith C., Fleischmann, Tobias, Wonnacott, Keith Merrell

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Walking the talk in digital transformation of regulatory review von Khalil, Ramy, Macdonald, Judith C, Gustafson, Andrew, Aljuburi, Lina, Bisordi, Fabio, Beakes-Read, Ginny

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Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem-Are We Ready for a Revolution? von Macdonald, Judith C., Isom, David C., Evans, Daniel D., Page, Katy J.

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Regulatory agilities impacting review timelines for Pfizer/BioNTech’s BNT162b2 mRNA COVID-19 vaccine: a retrospective study von Patel, Prisha, Macdonald, Judith C., Boobalan, Jayanthi, Marsden, Matthew, Rizzi, Ruben, Zenon, Marianne, Ren, Jinma, Chu, Haitao, Cappelleri, Joseph C., Roychoudhury, Satrajit, O’Brien, Julie, Izaki-Lee, Konoha, Boyce, Donna

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Regulatory considerations in oncologic biosimilar drug development von Macdonald, Judith C, Hartman, Helen, Jacobs, Ira A

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Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström’s Macroglobulinemia von Dimopoulos, Meletios A, Tedeschi, Alessandra, Trotman, Judith, García-Sanz, Ramón, Macdonald, David, Leblond, Veronique, Mahe, Beatrice, Herbaux, Charles, Tam, Constantine, Orsucci, Lorella, Palomba, M. Lia, Matous, Jeffrey V, Shustik, Chaim, Kastritis, Efstathios, Treon, Steven P, Li, Jianling, Salman, Zeena, Graef, Thorsten, Buske, Christian

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Alternatively activated dendritic cells regulate CD4⁺ T-cell polarization in vitro and in vivo von Cook, Peter C, Jones, Lucy H, Jenkins, Stephen J, Wynn, Thomas A, Allen, Judith E, MacDonald, Andrew S

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Alterations in amino acid status in cats with feline dysautonomia von McGorum, Bruce C, Symonds, Herb W, Knottenbelt, Clare, Cave, Tom A, MacDonald, Susan J, Stratton, Joanna, Leon, Irene, Turner, Judith A, Pirie, R Scott

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Tackling the escalating burden of care in Uganda: a qualitative exploration of the challenges experienced by family carers of patients with chronic non-communicable diseases von Montgomery, Lorna, Misinde, Cyprian, Komuhangi, Alimah, Kawooya, Angela N, Agaba, Peninah, McShane, Charlene M, Santin, Olinda, Apio, Judith, Jenkins, Christopher, Githinji, Florence, MacDonald, Mandi, Nakaggwa, Florence, Nanyonga, Rose C

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A dominant role for the methyl-CpG-binding protein Mbd2 in controlling Th2 induction by dendritic cells von Cook, Peter C., Owen, Heather, Deaton, Aimée M., Borger, Jessica G., Brown, Sheila L., Clouaire, Thomas, Jones, Gareth-Rhys, Jones, Lucy H., Lundie, Rachel J., Marley, Angela K., Morrison, Vicky L., Phythian-Adams, Alexander T., Wachter, Elisabeth, Webb, Lauren M., Sutherland, Tara E., Thomas, Graham D., Grainger, John R., Selfridge, Jim, McKenzie, Andrew N. J., Allen, Judith E., Fagerholm, Susanna C., Maizels, Rick M., Ivens, Alasdair C., Bird, Adrian, MacDonald, Andrew S.

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Accuracy and Precision of Tidal Wetland Soil Carbon Mapping in the Conterminous United States von Holmquist, James R., Windham-Myers, Lisamarie, Bliss, Norman, Crooks, Stephen, Morris, James T., Megonigal, J. Patrick, Troxler, Tiffany, Weller, Donald, Callaway, John, Drexler, Judith, Ferner, Matthew C., Gonneea, Meagan E., Kroeger, Kevin D., Schile-Beers, Lisa, Woo, Isa, Buffington, Kevin, Breithaupt, Joshua, Boyd, Brandon M., Brown, Lauren N., Dix, Nicole, Hice, Lyndie, Horton, Benjamin P., MacDonald, Glen M., Moyer, Ryan P., Reay, William, Shaw, Timothy, Smith, Erik, Smoak, Joseph M., Sommerfield, Christopher, Thorne, Karen, Velinsky, David, Watson, Elizabeth, Grimes, Kristin Wilson, Woodrey, Mark

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Proton Radiation Therapy for Pediatric Medulloblastoma and Supratentorial Primitive Neuroectodermal Tumors: Outcomes for Very Young Children Treated With Upfront Chemotherapy von Jimenez, Rachel B., MD, Sethi, Roshan, BS, Depauw, Nicolas, MSc, Pulsifer, Margaret B., PhD, Adams, Judith, BA, McBride, Sean M., MD, PhD, Ebb, David, MD, Fullerton, Barbara C., PhD, Tarbell, Nancy J., MD, Yock, Torunn I., MD, MacDonald, Shannon M., MD

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Parental history of positive development and child behavior in next generation offspring: A two‐cohort prospective intergenerational study von Letcher, Primrose, Greenwood, Christopher J., McAnally, Helena, Belsky, Jay, Macdonald, Jacqui A., Spry, Elizabeth A., Thomson, Kimberly C., O'Connor, Meredith, Sligo, Judith, Youssef, George, McIntosh, Jennifer E., Iosua, Ella, Hutchinson, Delyse, Cleary, Joyce, Sanson, Ann V., Patton, George C., Hancox, Robert J., Olsson, Craig A.

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Genome-wide rare variant score associates with morphological subtypes of autism spectrum disorder von Chan, Ada J. S., Engchuan, Worrawat, Reuter, Miriam S., Wang, Zhuozhi, Thiruvahindrapuram, Bhooma, Trost, Brett, Nalpathamkalam, Thomas, Negrijn, Carol, Lamoureux, Sylvia, Pellecchia, Giovanna, Patel, Rohan V., Sung, Wilson W. L., MacDonald, Jeffrey R., Howe, Jennifer L., Vorstman, Jacob, Sondheimer, Neal, Takahashi, Nicole, Miles, Judith H., Anagnostou, Evdokia, Tammimies, Kristiina, Zarrei, Mehdi, Merico, Daniele, Stavropoulos, Dimitri J., Yuen, Ryan K. C., Fernandez, Bridget A., Scherer, Stephen W.

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Dynamic Regulatory Assessment: evolving the European Regulatory Framework for the Benefit of Patients and Public Health—an EFPIA View von Herrero-Martinez, Esteban, Hussain, Nasir, Roux, Nadege Le, MacDonald, Judith, Mayer, Mark, Palacios, Rodrigo, Kühler, Thomas C.

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Energy balance measurement: when something is not better than nothing von Dhurandhar, N V, Schoeller, D, Brown, A W, Heymsfield, S B, Thomas, D, Sørensen, T I A, Speakman, J R, Jeansonne, M, Allison, D B

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Translating the Postcolonial in Multilingual Contexts von Anderson, Jean, Baker, Charlotte, Blin, Lynn, Gilbert, Catherine, Hussein, Mai, Macdonald, Megan C, Magdelaine-Andrianjafitrimo, Valérie, Malena, Anne, Misrahi-Barak, Judith, Munos, Delphine, Parisot, Yolaine, Ravi, Srilata, Steyn, Jan, Warner, Tobias, Waters, Julia

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Modulation of dendritic cell alternative activation and function by the vitamin A metabolite retinoic acid von Jones, Lucy H, Cook, Peter C, Ivens, Alasdair C, Thomas, Graham D, Phythian-Adams, Alexander T, Allen, Judith E, MacDonald, Andrew S

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Adolescent and young adult mental health problems and infant offspring behavior: Findings from a prospective intergenerational cohort study von Letcher, Primrose, Greenwood, Christopher J., Romaniuk, Helena, Spry, Elizabeth, Macdonald, Jacqui A., McAnally, Helena, Thomson, Kimberly C., Youssef, George, Hutchinson, Delyse, McIntosh, Jennifer, Sanson, Ann, Ryan, Joanne, Edwards, Ben, Sligo, Judith, Hancox, Robert J., Patton, George C., Olsson, Craig A.

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Left ventricular remodelling in rheumatic heart disease – trends over time and implications for follow-up in childhood von MacDonald, Bradley, Tarca, Adrian, Causer, Louise, Maslin, Katie, Bruce, Di, Schreiber-Wood, Rachel, Kumar, Mohit, Ramsay, James, Andrews, David, Budgeon, Charley, Katzenellenbogen, Judith, Bowen, Asha C, Carapetis, Jonathan, Friedberg, Mark K, Yim, Deane

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