Pharmacogenomic information in drug labels: European Medicines Agency perspective von Ehmann, F, Caneva, L, Prasad, K, Paulmichl, M, Maliepaard, M, Llerena, A, Ingelman-Sundberg, M, Papaluca-Amati, M

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Phenotype Standardization for Immune-Mediated Drug-Induced Skin Injury von Pirmohamed, M, Friedmann, PS, Molokhia, M, Loke, YK, Smith, C, Phillips, E, La Grenade, L, Carleton, B, Papaluca‐Amati, M, Demoly, P, Shear, NH

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Gatekeepers and Enablers: How Drug Regulators Respond to a Challenging and Changing Environment by Moving Toward a Proactive Attitude von Ehmann, F, Papaluca Amati, M, Salmonson, T, Posch, M, Vamvakas, S, Hemmings, R, Eichler, H G, Schneider, C K

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Pharmacogenomics: Role in Medicines Approval and Clinical Use von Novelli, G., Borgiani, P., Ciccacci, C., Di Daniele, N., Sirugo, G., Amati, M. Papaluca

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Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency von Elsäßer, Amelie, Regnstrom, Jan, Vetter, Thorsten, Koenig, Franz, Hemmings, Robert James, Greco, Martina, Papaluca-Amati, Marisa, Posch, Martin

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Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact von Goodsaid, Federico M, Amur, Shashi, Aubrecht, Jiri, Burczynski, Michael E, Carl, Kevin, Catalano, Jennifer, Charlab, Rosane, Close, Sandra, Cornu-Artis, Catherine, Essioux, Laurent, Fornace, Albert J, Hinman, Lois, Hong, Huixiao, Hunt, Ian, Jacobson-Kram, David, Jawaid, Ansar, Laurie, David, Lesko, Lawrence, Li, Heng-Hong, Lindpaintner, Klaus, Mayne, James, Morrow, Peter, Papaluca-Amati, Marisa, Robison, Timothy W, Roth, John, Schuppe-Koistinen, Ina, Shi, Leming, Spleiss, Olivia, Tong, Weida, Truter, Sharada L, Vonderscher, Jacky, Westelinck, Agnes, Zhang, Li, Zineh, Issam

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The advanced therapy classification procedure: Overview of experience gained so far1 von Voltz-Girolt, C., Celis, P., Boucaumont, M., D’Apote, L., Pinheiro, M.-H., Papaluca-Amati, M.

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The advanced therapy classification procedure. Overview of experience gained so far von Voltz-Girolt, C, Celis, P, Boucaumont, M, D'Apote, L, Pinheiro, M-H, Papaluca-Amati, M

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Safety of Biotechnological Products von Bass, Rolf, Purves, J., Amati, M. Papaluca

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EMEA and Gene Therapy Medicinal Products Development in the European Union von Papaluca Amati, Marisa, Pignatti, Francesco, Nolte, Alexis, Amerasinghe, Nirosha, Gustafsson, Daniel, Moulon, Isabelle, Le Courtois, Patrick

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