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1
New toxicity testing of PQ grass allergy immunotherapy to support product development
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Artigo
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New toxicity testing of PQ grass allergy immunotherapy to support product development

Baldrick, Paul ; Hutchings, James W. ; Heath, Matthew D. ; Skinner, Murray A. ; Martin, Tom ; Gray, Chris

Journal of applied toxicology, 2019-10, Vol.39 (10), p.1462-1469 [Periódico revisado por pares]

England: Wiley Subscription Services, Inc

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Trends in the development of human stem cell-based non-animal drug testing models
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Artigo
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Trends in the development of human stem cell-based non-animal drug testing models

Lee, Su-Jin ; Lee, Hyang-Ae

The Korean Journal of Physiology & Pharmacology, 2020, 24(6), , pp.441-452 [Periódico revisado por pares]

The Korean Physiological Society and The Korean Society of Pharmacology

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3
Mathematical model of volume kinetics and renal function after burn injury and resuscitation
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Artigo
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Mathematical model of volume kinetics and renal function after burn injury and resuscitation

Arabidarrehdor, Ghazal ; Tivay, Ali ; Bighamian, Ramin ; Meador, Chris ; Kramer, George C. ; Hahn, Jin-Oh ; Salinas, Jose

Burns, 2021-03, Vol.47 (2), p.371-386 [Periódico revisado por pares]

Netherlands: Elsevier Ltd

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4
Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies
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Artigo
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Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

Brennan, Frank R. ; Morton, Laura Dill ; Spindeldreher, Sebastian ; Kiessling, Andrea ; Allenspach, Roy ; Hey, Adam ; Müller, Patrick ; Frings, Werner ; Sims, Jennifer

mAbs, 2010-05, Vol.2 (3), p.233-255 [Periódico revisado por pares]

United States: Taylor & Francis

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5
Protecting future generations by regulatory approaches
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Artigo
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Protecting future generations by regulatory approaches

Roberts, Linda G. ; Hoberman, Alan M.

Current opinion in toxicology, 2023-09, Vol.35, p.100422, Article 100422 [Periódico revisado por pares]

Elsevier B.V

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6
Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals
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Artigo
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Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals

Korde, Aruna ; Mikolajczak, Renata ; Kolenc, Petra ; Bouziotis, Penelope ; Westin, Hadis ; Lauritzen, Mette ; Koole, Michel ; Herth, Matthias Manfred ; Bardiès, Manuel ; Martins, Andre F. ; Paulo, Antonio ; Lyashchenko, Serge K. ; Todde, Sergio ; Nag, Sangram ; Lamprou, Efthimis ; Abrunhosa, Antero ; Giammarile, Francesco ; Decristoforo, Clemens

EJNMMI radiopharmacy and chemistry, 2022-07, Vol.7 (1), p.18-18, Article 18 [Periódico revisado por pares]

Cham: Springer International Publishing

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7
FcγRIIIa-dependent IFN-γ release in whole blood assay is predictive of therapeutic IgG1 antibodies safety
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Artigo
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FcγRIIIa-dependent IFN-γ release in whole blood assay is predictive of therapeutic IgG1 antibodies safety

Alakhras, Nada S ; Qiu, Jiabin ; Rocha, Guilherme V ; Witcher, Derrick R ; Koester, Anja ; You, Jinsam ; Schaer, David A ; Holmgaard, Rikke B ; Driscoll, Kyla ; Willy, Jeffrey A ; Malherbe, Laurent P

mAbs, 2018-08, Vol.10 (6), p.913-921 [Periódico revisado por pares]

United States: Taylor & Francis

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8
Non-clinical safety evaluation of novel vaccines and adjuvants: new products, new strategies
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Artigo
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Non-clinical safety evaluation of novel vaccines and adjuvants: new products, new strategies

Brennan, Frank R. ; Dougan, Gordon

Vaccine, 2005-05, Vol.23 (24), p.3210-3222 [Periódico revisado por pares]

Oxford: Elsevier Ltd

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9
FcγRIIIa-dependent IFN-γ release in whole blood assay is predictive of therapeutic IgG1 antibodies safety
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Report
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FcγRIIIa-dependent IFN-γ release in whole blood assay is predictive of therapeutic IgG1 antibodies safety

Alakhras, Nada S. ; Qiu, Jiabin ; Rocha, Guilherme V. ; Witcher, Derrick R. ; Koester, Anja ; You, Jinsam ; Schaer, David A. ; Holmgaard, Rikke B. ; Driscoll, Kyla ; Willy, Jeffrey A. ; Malherbe, Laurent P.

mAbs, 2018, Vol.10 (6), p.913-921

Taylor & Francis

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10
Joint EFPIA/CHMP SWP workshop: the Emerging Use of Omic Technologies for Regulatory Non-Clinical Safety Testing
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Joint EFPIA/CHMP SWP workshop: the Emerging Use of Omic Technologies for Regulatory Non-Clinical Safety Testing

Kasper, Peter ; Oliver, Gerry ; Lima, Beatriz Silva ; Singer, Thomas ; Tweats, David

Pharmacogenomics, 2005-03, Vol.6 (2), p.181-184 [Periódico revisado por pares]

England: Future Medicine Ltd

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