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Contribution of animal studies to evaluate the similarity of biosimilars to reference products.

van Meer, Peter J K ; Ebbers, Hans C ; Kooijman, Marlous ; Gispen-de Wied, Christine C ; Silva-Lima, Beatriz ; Moors, Ellen H M ; Schellekens, Huub van Meer, Peter J K (correspondence author) ; van Meer, Peter J K (record owner) April 2015

Drug discovery today, Vol.20(4), pp.483-490 [Peer Reviewed Journal]

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Immunogenicity of therapeutic proteins: the use of animal models.

Brinks, Vera ; Jiskoot, Wim ; Schellekens, Huub Brinks, Vera (correspondence author) ; Brinks, Vera (record owner)

Pharmaceutical research, October 2011, Vol.28(10), pp.2379-2385 [Peer Reviewed Journal]

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Clinical comparability and European biosimilar regulations.

Schellekens, Huub ; Moors, Ellen Schellekens, Huub (correspondence author) ; Schellekens, Huub (record owner)

Nature biotechnology, January 2010, Vol.28(1), pp.28-31 [Peer Reviewed Journal]

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Overregulering en onnodige dierproeven: eisen voor markttoelating van biofarmaceutica zijn te star.
Overregulation and unnecessary animal testing: requirements for market approval of biopharmaceuticals too rigid

Schellekens, Huub

Nederlands tijdschrift voor geneeskunde, 2012, Vol.156(50), pp.A5723 [Peer Reviewed Journal]

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The ability of animal studies to detect serious post marketing adverse events is limited.

van Meer, Peter J K ; Kooijman, Marlous ; Gispen-de Wied, Christine C ; Moors, Ellen H M ; Schellekens, Huub van Meer, Peter J K (correspondence author) ; van Meer, Peter J K (record owner)

Regulatory toxicology and pharmacology : RTP, December 2012, Vol.64(3), pp.345-349 [Peer Reviewed Journal]

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Measures of biosimilarity in monoclonal antibodies in oncology : the case of bevacizumab

Ebbers, Hans C ; van Meer, Peter J K ; Moors, Ellen H M ; Mantel-Teeuwisse, Aukje K ; Leufkens, Hubert G M ; Schellekens, Huub

Drug Discovery Today, 2013, Vol.18(17-18), pp.872-6446 [Peer Reviewed Journal]

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Reassessments of ESAs for cancer treatment in the US and Europe.(Important and Emerging Drug Classes)

Bennett, Charles L. ; Mckoy, June M. ; Henke, Michael ; Silver, Samuel M. ; Macdougall, Iain C. ; Birgegard, Gunnar ; Luminari, Stefano ; Casadevall, Nicole ; Schellekens, Huub ; Sartor, Oliver ; Lai, Stephen Y. ; Armitage, James O.

Oncology, March, 2010, Vol.24(3), p.260 [Peer Reviewed Journal]

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Immunogenicity of mAbs in non-human primates during nonclinical safety assessment.

van Meer, Peter J K ; Kooijman, Marlous ; Brinks, Vera ; Gispen-de Wied, Christine C ; Silva-Lima, Beatriz ; Moors, Ellen H M ; Schellekens, Huub van Meer, Peter J K (correspondence author) ; van Meer, Peter J K (record owner)

mAbs, 2013 Sep-Oct, Vol.5(5), pp.810-816 [Peer Reviewed Journal]

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Value for money of drug regulation

Bouvy, Jacoline C ; Koopmanschap, Marc A ; Schellekens, Huub

Expert Review of Pharmacoeconomics & Outcomes Research, 01 June 2012, Vol.12(3), pp.247-249 [Peer Reviewed Journal]

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The Rebif new formulation story: it's not trials and error.

Jaber, Amer ; Driebergen, Reinoud ; Giovannoni, Gavin ; Schellekens, Huub ; Simsarian, James ; Antonelli, Michele Jaber, Amer (correspondence author) ; Jaber, Amer (record owner) 2007

Drugs in R&D, Vol.8(6), pp.335-348 [Peer Reviewed Journal]

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