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Items: 1 to 20 of 115

1.

Are some animal models more equal than others? A case study on the translational value of animal models of efficacy for Alzheimer's disease.

Veening-Griffioen DH, Ferreira GS, van Meer PJK, Boon WPC, Gispen-de Wied CC, Moors EHM, Schellekens H.

Eur J Pharmacol. 2019 Jul 7;859:172524. doi: 10.1016/j.ejphar.2019.172524. [Epub ahead of print]

PMID:
31291566
2.

Are we ready to close the discussion on the interchangeability of biosimilars?

Ebbers HC, Schellekens H.

Drug Discov Today. 2019 Jun 26. pii: S1359-6446(19)30141-2. doi: 10.1016/j.drudis.2019.06.016. [Epub ahead of print]

3.

A standardised framework to identify optimal animal models for efficacy assessment in drug development.

S Ferreira G, Veening-Griffioen DH, Boon WPC, Moors EHM, Gispen-de Wied CC, Schellekens H, van Meer PJK.

PLoS One. 2019 Jun 13;14(6):e0218014. doi: 10.1371/journal.pone.0218014. eCollection 2019.

4.

Liposome-targeted recombinant human acid sphingomyelinase: Production, formulation, and in vitro evaluation.

Aldosari MH, de Vries RP, Rodriguez LR, Hesen NA, Beztsinna N, van Kuilenburg ABP, Hollak CEM, Schellekens H, Mastrobattista E.

Eur J Pharm Biopharm. 2019 Apr;137:185-195. doi: 10.1016/j.ejpb.2019.02.019. Epub 2019 Feb 25.

PMID:
30818011
5.

Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product.

Halim LA, Márquez M, Maas-Bakker RF, Castañeda-Hernández G, Jiskoot W, Schellekens H.

Pharm Res. 2018 Oct 2;35(11):226. doi: 10.1007/s11095-018-2491-5.

6.

Evaluation of the suitability of a Sprague Dawley rat model to assess intravenous iron preparations.

Span K, Pieters EHE, Brinks V, Hennink WE, Schellekens H.

J Pharmacol Toxicol Methods. 2018 May - Jun;91:7-17. doi: 10.1016/j.vascn.2017.12.001. Epub 2017 Dec 24.

PMID:
29278742
7.

Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases.

Kay J, Schoels MM, Dörner T, Emery P, Kvien TK, Smolen JS, Breedveld FC; Task Force on the Use of Biosimilars to Treat Rheumatological Diseases.

Ann Rheum Dis. 2018 Feb;77(2):165-174. doi: 10.1136/annrheumdis-2017-211937. Epub 2017 Sep 2.

PMID:
28866648
8.

Erratum: Making individualized drugs a reality.

Schellekens H, Aldosari M, Talsma H, Mastrobattista E.

Nat Biotechnol. 2017 Aug 8;35(8):797. doi: 10.1038/nbt0817-797c. No abstract available.

PMID:
28787402
9.

Making individualized drugs a reality.

Schellekens H, Aldosari M, Talsma H, Mastrobattista E.

Nat Biotechnol. 2017 Jun;35(6):507-513. doi: 10.1038/nbt.3888. Epub 2017 Jun 5. No abstract available. Erratum in: Nat Biotechnol. 2017 Aug 8;35(8):797.

PMID:
28581491
10.

Polyphosphate nanoparticles on the platelet surface trigger contact system activation.

Verhoef JJ, Barendrecht AD, Nickel KF, Dijkxhoorn K, Kenne E, Labberton L, McCarty OJ, Schiffelers R, Heijnen HF, Hendrickx AP, Schellekens H, Fens MH, de Maat S, Renné T, Maas C.

Blood. 2017 Mar 23;129(12):1707-1717. doi: 10.1182/blood-2016-08-734988. Epub 2017 Jan 3.

11.

Iron nanomedicines induce Toll-like receptor activation, cytokine production and complement activation.

Verhoef JJF, de Groot AM, van Moorsel M, Ritsema J, Beztsinna N, Maas C, Schellekens H.

Biomaterials. 2017 Mar;119:68-77. doi: 10.1016/j.biomaterials.2016.11.025. Epub 2016 Nov 21.

PMID:
28002754
12.

Hybrid mass spectrometry approaches in glycoprotein analysis and their usage in scoring biosimilarity.

Yang Y, Liu F, Franc V, Halim LA, Schellekens H, Heck AJ.

Nat Commun. 2016 Nov 8;7:13397. doi: 10.1038/ncomms13397.

13.

Safety and efficacy of biosimilars in oncology.

Schellekens H, Smolen JS, Dicato M, Rifkin RM.

Lancet Oncol. 2016 Nov;17(11):e502-e509. doi: 10.1016/S1470-2045(16)30374-6. Review. Erratum in: Lancet Oncol. 2017 Mar;18(3):e134.

PMID:
27819248
14.

A novel oral iron-complex formulation: Encapsulation of hemin in polymeric micelles and its in vitro absorption.

Span K, Verhoef JJF, Hunt H, van Nostrum CF, Brinks V, Schellekens H, Hennink WE.

Eur J Pharm Biopharm. 2016 Nov;108:226-234. doi: 10.1016/j.ejpb.2016.09.002. Epub 2016 Sep 4.

PMID:
27600943
15.

Quality and Batch-to-Batch Consistency of Original and Biosimilar Epoetin Products.

Halim LA, Brinks V, Jiskoot W, Romeijn S, Haselberg R, Burns C, Wadhwa M, Schellekens H.

J Pharm Sci. 2016 Feb;105(2):542-550. doi: 10.1016/j.xphs.2015.10.019. Epub 2016 Jan 9.

PMID:
26869417
16.

Immunogenicity of Recombinant Human Interferon Beta-1b in Immune-Tolerant Transgenic Mice Corresponds with the Biophysical Characteristics of Aggregates.

Abdolvahab MH, Fazeli A, Halim A, Sediq AS, Fazeli MR, Schellekens H.

J Interferon Cytokine Res. 2016 Apr;36(4):247-57. doi: 10.1089/jir.2015.0108. Epub 2016 Feb 2.

PMID:
26835734
17.

An Albumin-Free Formulation for Escherichia coli-Derived Interferon Beta-1b with Decreased Immunogenicity in Immune Tolerant Mice.

Abdolvahab MH, Fazeli A, Radmalekshahi M, Nejadnik MR, Fazeli MR, Schellekens H.

J Interferon Cytokine Res. 2016 Mar;36(3):192-203. doi: 10.1089/jir.2015.0110. Epub 2016 Jan 29.

PMID:
26824268
18.

Biosimilar monoclonal antibodies: the scientific basis for extrapolation.

Schellekens H, Lietzan E, Faccin F, Venema J.

Expert Opin Biol Ther. 2015;15(11):1633-46. doi: 10.1517/14712598.2015.1083552. Epub 2015 Sep 12. Review.

PMID:
26365396
19.

Label-free glycoprofiling with multiplex surface plasmon resonance: a tool to quantify sialylation of erythropoietin.

Geuijen KP, Halim LA, Schellekens H, Schasfoort RB, Wijffels RH, Eppink MH.

Anal Chem. 2015 Aug 18;87(16):8115-22. doi: 10.1021/acs.analchem.5b00870. Epub 2015 Jul 29.

PMID:
26192159
20.

The constrained prescription, interchangeability and substitution of biosimilars.

Minghetti P, Rocco P, Schellekens H.

Nat Biotechnol. 2015 Jul;33(7):688-9. doi: 10.1038/nbt.3272. No abstract available.

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