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ACCELERATE and European Medicines Agency Paediatric Strategy Forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patientsPearson, Andrew D.J. ; Rossig, Claudia ; Lesa, Giovanni ; Diede, Scott J. ; Weiner, Susan ; Anderson, John ; Gray, Juliet ; Geoerger, Birgit ; Minard-Colin, Veronique ; Marshall, Lynley V. ; Smith, Malcolm ; Sondel, Paul ; Bajars, Marcis ; Baldazzi, Claudia ; Barry, Elly ; Blackman, Sam ; Blanc, Patricia ; Capdeville, Renaud ; Caron, Hubert ; Cole, Peter D. ; Jiménez, Jorge Camarero ; Demolis, Pierre ; Donoghue, Martha ; Elgadi, Mabrouck ; Gajewski, Thomas ; Galluzzo, Sara ; Ilaria, Robert ; Jenkner, Alessandro ; Karres, Dominik ; Kieran, Mark ; Ligas, Franca ; Lowy, Israel ; Meyers, Michael ; Oprea, Corina ; Peddareddigari, Vijay G.R. ; Sterba, Jaroslav ; Stockman, Paul K. ; Suenaert, Peter ; Tabori, Uri ; van Tilburg, Cornelis ; Yancey, Todd ; Weigel, Brenda ; Norga, Koenraad ; Reaman, Gregory ; Vassal, GillesEuropean journal of cancer (1990), 2020-03, Vol.127, p.52-66 [Periódico revisado por pares]England: Elsevier LtdTexto completo disponível |
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ACCELERATE and European Medicine Agency Paediatric Strategy Forum for medicinal product development for mature B-cell malignancies in childrenPearson, Andrew D.J. ; Scobie, Nicole ; Norga, Koenraad ; Ligas, Franca ; Chiodin, Davy ; Burke, Amos ; Minard-Colin, Veronique ; Adamson, Peter ; Marshall, Lynley V. ; Balakumaran, Arun ; Benettaib, Bouchra ; Bhargava, Pankaj ; Bollard, Catherine M. ; Bolotin, Ellen ; Bomken, Simon ; Buechner, Jochen ; Burkhardt, Birgit ; Caron, Hubert ; Copland, Christopher ; Demolis, Pierre ; Egorov, Anton ; Farhan, Mahdi ; Zugmaier, Gerhard ; Gross, Thomas ; Horton-Taylor, Danielle ; Klapper, Wolfram ; Lesa, Giovanni ; Marcus, Robert ; Miles, Rodney R. ; Nottage, Kerri ; Pacaud, Lida ; Ricafort, Rosanna ; Schrappe, Martin ; Sterba, Jaroslav ; Vezan, Remus ; Weiner, Susan ; Kim, Su Young ; Reaman, Gregory ; Vassal, GillesEuropean journal of cancer (1990), 2019-03, Vol.110, p.74-85 [Periódico revisado por pares]England: Elsevier LtdTexto completo disponível |
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FDA orphan products clinical trial grants: assessment of outcomes and impact on rare disease product developmentMiller, Kathleen L ; Mueller, Christine ; Liu, Gumei ; Miller Needleman, Katherine I ; Maynard, JanetOrphanet journal of rare diseases, 2020-09, Vol.15 (1), p.1-234, Article 234 [Periódico revisado por pares]London: BioMed Central LtdTexto completo disponível |
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Operational differences between product development partnership, pharmaceutical industry, and investigator initiated clinical trialsNebie, Eric I ; van Eeuwijk, Peter ; Sawadogo, Hélène N ; Reus, Elisabeth ; Utzinger, Jürg ; Burri, ChristianTropical medicine and infectious disease, 2024-02, Vol.9 (3), p.1-15 [Periódico revisado por pares]Basel, Switzerland: MDPITexto completo disponível |
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Drug discovery and development for neglected diseases: the DNDi modelChatelain, Eric ; Ioset, Jean-RobertDrug design, development and therapy, 2011-03, Vol.5 (default), p.175-181 [Periódico revisado por pares]New Zealand: Taylor & Francis LtdTexto completo disponível |
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Innovation risks of outsourcing in pharmaceutical new product developmentLowman, M. ; Trott, P. ; Hoecht, A. ; Sellam, Z.Technovation, 2012-02, Vol.32 (2), p.99-109 [Periódico revisado por pares]Amsterdam: Elsevier LtdTexto completo disponível |
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Material Type: Artigo
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Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product DevelopmentPerry, Brian ; Dombeck, Carrie ; Smalley, Jaye Bea ; Levitan, Bennett ; Leventhal, David ; Patrick-Lake, Bray ; Brennan, Linda ; McKenna, Kevin ; Hallinan, Zachary ; Corneli, AmyTherapeutic innovation & regulatory science, 2021-03, Vol.55 (2), p.324-335 [Periódico revisado por pares]Cham: Springer International PublishingTexto completo disponível |
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Material Type: Artigo
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Developing Covid-19 Vaccines at Pandemic SpeedLurie, Nicole ; Saville, Melanie ; Hatchett, Richard ; Halton, JaneThe New England journal of medicine, 2020-05, Vol.382 (21), p.1969-1973 [Periódico revisado por pares]United States: Massachusetts Medical SocietyTexto completo disponível |
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Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018Wouters, Olivier J ; McKee, Martin ; Luyten, JeroenJAMA : the journal of the American Medical Association, 2020-03, Vol.323 (9), p.844-853 [Periódico revisado por pares]United States: American Medical AssociationTexto completo disponível |
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Alzheimer's disease drug development pipeline: 2019Cummings, Jeffrey ; Lee, Garam ; Ritter, Aaron ; Sabbagh, Marwan ; Zhong, KateAlzheimer's & dementia : translational research & clinical interventions, 2019, Vol.5 (1), p.272-293 [Periódico revisado por pares]United States: Elsevier IncTexto completo disponível |