Next-generation nanomedicines and nanosimilars: EU regulators initiatives relating to the development and evaluation of nanomedicines
Ehmann, Falk, Sakai-Kato, Kumiko, Duncan, Ruth, Pérez de la Ossa, Dolores Hernán, Pita, Ruben, Vidal, Jean-Marc, Kohli, Ashish, Tothfalusi, Laszlo, Sanh, Alan, Tinton, Sandrine, Robert, Jean-Louis, Silva Lima, Beatriz, Amati, Marisa Papaluca
Published in Nanomedicine (London, England) (01.05.2013)
Published in Nanomedicine (London, England) (01.05.2013)
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A good practice guide to the administration of substances and removal of blood, including routes and volumes
Diehl, Karl-Heinz, Hull, Robin, Morton, David, Pfister, Rudolf, Rabemampianina, Yvon, Smith, David, Vidal, Jean-Marc, Vorstenbosch, Cor Van De
Published in Journal of applied toxicology (01.01.2001)
Published in Journal of applied toxicology (01.01.2001)
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A call for action on the development and implementation of new methodologies for safety assessment of chemical-based products in the EU – A short communication
Knight, Derek J., Deluyker, Hubert, Chaudhry, Qasim, Vidal, Jean-Marc, de Boer, Alie
Published in Regulatory toxicology and pharmacology (01.02.2021)
Published in Regulatory toxicology and pharmacology (01.02.2021)
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Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European medicines agency workshop on juvenile animal testing for nonclinical assessors
Silva-Lima, Beatriz, Due Theilade-Thomsen, Mette, Carleer, Jacqueline, Vidal, Jean-Marc, Tomasi, Paolo, Saint-Raymond, Agnes
Published in Birth defects research. Part B, Developmental and reproductive toxicology (01.12.2010)
Published in Birth defects research. Part B, Developmental and reproductive toxicology (01.12.2010)
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Conference Proceeding
Towards consensus practices to qualify safety biomarkers for use in early drug development
Sistare, Frank D, Dieterle, Frank, Troth, Sean, Holder, Daniel J, Gerhold, David, Andrews-Cleavenger, Dina, Baer, William, Betton, Graham, Bounous, Denise, Carl, Kevin, Collins, Nathaniel, Goering, Peter, Goodsaid, Federico, Gu, Yi-Zhong, Guilpin, Valerie, Harpur, Ernie, Hassan, Alita, Jacobson-Kram, David, Kasper, Peter, Laurie, David, Lima, Beatriz Silva, Maciulaitis, Romaldas, Mattes, William, Maurer, Gérard, Obert, Leslie Ann, Ozer, Josef, Papaluca-Amati, Marisa, Phillips, Jonathan A, Pinches, Mark, Schipper, Matthew J, Thompson, Karol L, Vamvakas, Spiros, Vidal, Jean-Marc, Vonderscher, Jacky, Walker, Elizabeth, Webb, Craig, Yu, Yan
Published in Nature biotechnology (01.05.2010)
Published in Nature biotechnology (01.05.2010)
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A generic operational strategy to qualify translational safety biomarkers
Matheis, Katja, Laurie, David, Andriamandroso, Christiane, Arber, Nadir, Badimon, Lina, Benain, Xavier, Bendjama, Kaïdre, Clavier, Isabelle, Colman, Peter, Firat, Hüseyin, Goepfert, Jens, Hall, Steve, Joos, Thomas, Kraus, Sarah, Kretschmer, Axel, Merz, Michael, Padro, Teresa, Planatscher, Hannes, Rossi, Annamaria, Schneiderhan-Marra, Nicole, Schuppe-Koistinen, Ina, Thomann, Peter, Vidal, Jean-Marc, Molac, Béatrice
Published in Drug discovery today (01.07.2011)
Published in Drug discovery today (01.07.2011)
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In vitro cytokine release assays for predicting cytokine release syndrome: The current state-of-the-science. Report of a European Medicines Agency Workshop
Vidal, Jean-Marc, Kawabata, Thomas T., Thorpe, Robin, Silva-Lima, Beatriz, Cederbrant, Karin, Poole, Stephen, Mueller-Berghaus, Jan, Pallardy, Marc, Van der Laan, Jan-Willem
Published in Cytokine (01.08.2010)
Published in Cytokine (01.08.2010)
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Conference Proceeding
Report of the EPAA-ECVAM workshop on the validation of Integrated Testing Strategies (ITS)
Kinsner-Ovaskainen, Agnieszka, Maxwell, Gavin, Kreysa, Joachim, Barroso, João, Adriaens, Els, Alépée, Natalie, Berg, Ninna, Bremer, Susanne, Coecke, Sandra, Comenges, José Z, Corvi, Raffaella, Casati, Silvia, Dal Negro, Gianni, Marrec-Fairley, Monique, Griesinger, Claudius, Halder, Marlies, Heisler, Eckhard, Hirmann, Doris, Kleensang, André, Kopp-Schneider, Annette, Lapenna, Silvia, Munn, Sharon, Prieto, Pilar, Schechtman, Len, Schultz, Terry, Vidal, Jean-Marc, Worth, Andrew, Zuang, Valérie
Published in Alternatives to laboratory animals (01.07.2012)
Published in Alternatives to laboratory animals (01.07.2012)
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Optimisation of the post-validation process: the report and recommendations of ECVAM Workshop 67
Bottini, Annamaria A, Alepee, Natalie, Phillips, Barry, Gribaldo, Laura, De Silva, Odile, Hartung, Thomas, Hendriksen, Coenraad, Kuil, Janne, Pazos, Patricia, Rhein, Cornelius, Schiffelers, Marie-Jeanne, Stokes, William, Theobald, Anne, Vidal, Jean-Marc, Van de Sandt, Han, Breier, Siegfried, Sintes, Juan R, Blaauboer, Bas
Published in Alternatives to laboratory animals (01.07.2008)
Published in Alternatives to laboratory animals (01.07.2008)
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Environmental Assessment for Human Medicines in the European Union
Spindler, Per, Montforts, Mark, Olejniczak, Klaus, Koschorreck, Jan, Vidal, Jean-Marc, Johansson, Anna-Karin, Stemplewski, Henry, Virtanen, Virpi, Rönnefahrt, Ines, Kristensen, Steen, van der Laan, Jan-Willem
Published in Drug information journal (01.03.2007)
Published in Drug information journal (01.03.2007)
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Development of the ICH Guidelines for Immunotoxicology Evaluation of Pharmaceuticals Using a Survey of Industry Practices
Weaver, James L., Tsutsui, Naohisa, Hisada, Shigeru, Vidal, Jean-Marc, Spanhaak, Steven, Sawada, Jun-ichi, Hastings, Kenneth L., van der Laan, Jan Willem, van Loveren, Henk, Kawabata, Thomas T., Sims, Jennifer, Durham, Stephen K., Fueki, Osamu, Matula, Tibor I., Kusunoki, Hirofumi, Ulrich, Peter, Nakamura, Kazuichi
Published in Journal of immunotoxicology (01.07.2005)
Published in Journal of immunotoxicology (01.07.2005)
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Next-generation nanomedicines and nanosimilars: EU regulators'initiatives relating to the development and evaluation of nanomedicines
Ehmann, Falk, Sakai-Kato, Kumiko, Duncan, Ruth, Pérez De La Ossa, Dolores Hernán, Pita, Ruben, Vidal, Jean-Marc, Kohli, Ashish, Tothfalusi, Laszlo, Sanh, Alan, Tinton, Sandrine, Robert, Jean-Louis, Silva Lima, Beatriz, Amati, Marisa Papaluca
Published in Nanomedicine (London, England) (01.05.2013)
Published in Nanomedicine (London, England) (01.05.2013)
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A generic operational strategy to qualify translational safety biomokers
MATHEIS, Katja, LAURIE, David, GOEPFERT, Jens, HALL, Steve, JOOS, Thomas, KRAUS, Sarah, KRETSCHMER, Axel, MERZ, Michael, PADRO, Teresa, PLANATSCHER, Hannes, ROSSI, Annamaria, SCHNEIDERHAN-MARRA, Nicole, ANDRIAMANDROSO, Christiane, SCHUPPE-KOISTINEN, Ina, THOMANN, Peter, VIDAL, Jean-Marc, MOLAC, Béatrice, ARBER, Nadir, BADIMON, Lina, BENAIN, Xavier, BENDJAMA, Kaïdre, CLAVIER, Isabelle, COLMAN, Peter, FIRAT, Hüseyin
Published in Drug discovery today (2011)
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Published in Drug discovery today (2011)
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Towards consensus practices to qualify safety biomarkers for use in early drug development : The predictive safety testing consortium
SISTARE, Frank D, DIETERLE, Frank, COLLINS, Nathaniel, GOERING, Peter, GOODSAID, Federico, GU, Yi-Zhong, GUILPIN, Valerie, HARPUR, Ernie, HASSAN, Alita, JACOBSON-KRAM, David, KASPER, Peter, LAURIE, David, TROTH, Sean, SILVA LIMA, Beatriz, MACIULAITIS, Romaldas, MATTES, William, MAURER, Gérard, OBERT, Leslie Ann, OZER, Josef, PAPALUCA-AMATI, Marisa, PHILLIPS, Jonathan A, PINCHES, Mark, SCHIPPER, Matthew J, HOLDER, Daniel J, THOMPSON, Karol L, VAMVAKAS, Spiros, VIDAL, Jean-Marc, VONDERSCHER, Jacky, WALKER, Elizabeth, WEBB, Craig, YAN YU, GERHOLD, David, ANDREWS-CLEAVENGER, Dina, BAER, William, BETTON, Graham, BOUNOUS, Denise, CARL, Kevin
Published in Nature biotechnology (2010)
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Published in Nature biotechnology (2010)
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Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium : The predictive safety testing consortium
DIETERLE, Frank, SISTARE, Frank, SULTANA, Stefan, GERHOLD, David L, PHILLIPS, Jonathan A, MAURER, Gérard, CARL, Kevin, LAURIE, David, HARPUR, Ernie, SONEE, Manisha, ENNULAT, Daniela, HOLDER, Dan, GOODSAID, Federico, ANDREWS-CLEAVENGER, Dina, GU, Yi-Zhong, THOMPSON, Karol L, GOERING, Peter L, VIDAL, Jean-Marc, ABADIE, Eric, MACIULAITIS, Romaldas, JACOBSON-KRAM, David, DEFELICE, Albert F, HAUSNER, Elizabeth A, PAPALUCA, Marisa, BLANK, Melanie, THOMPSON, Aliza, HARLOW, Patricia, THROCKMORTON, Douglas, SHEN XIAO, XU, Nancy, TAYLOR, William, VAMVAKAS, Spiros, FLAMION, Bruno, SILVA LIMA, Beatriz, OZER, Josef S, KASPER, Peter, PASANEN, Markku, PRASAD, Krishna, TROTH, Sean, BOUNOUS, Denise, ROBINSON-GRAVATT, Denise, BETTON, Graham, DAVIS, Myrtle A, AKUNDA, Jackie, MCDUFFIE, James Eric, WEBB, Craig P, SUTER, Laura, OBERT, Leslie, GUFFROY, Magalie, PINCHES, Mark, JAYADEV, Supriya, BLOMME, Eric A, BEUSHAUSEN, Sven A, BARLOW, Valérie G, COLLINS, Nathaniel, WARING, Jeff, BAER, William, SENAGORE, Anthony, SCHIPPER, Matthew J, VONDERSCHER, Jacky
Published in Nature biotechnology (2010)
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Published in Nature biotechnology (2010)
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The European IMI SAFE-T Consortium: Qualification of translational safety biomarkers
Dieterle, Frank, Schuppe-Koistinen, Ina, Prats, Neus, Brown, Lauren, Cacoub, Patrice, Poynard, Thierry, Keenan, Joe, Krahn, Thomas, Kalkuhl, Arno, Neumann, Ulf, Padro, Teresa, Joos, Thomas, Briner, Karin, Vidal, Jean-Marc, Hasselden, John, Firat, Huesseyin, Cochard, Landry, Schneierhahn, Nicole, Robinson-Gravatt, Denise, Doesegger, Lucette, Arber, Nadir
Published in Toxicology letters (13.09.2009)
Published in Toxicology letters (13.09.2009)
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