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Translatability of preclinical to early clinical tolerable and pharmacologically active dose ranges for central nervous system active drugs.
- Published in:
- Translational Psychiatry, 2023, v. 13, n. 1, p. 1, doi. 10.1038/s41398-023-02353-1
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- Publication type:
- Article
Tradition, Not Science, Is the Basis of Animal Model Selection in Translational and Applied Research.
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- Altex, 2021, v. 38, n. 1, p. 49, doi. 10.14573/altex.2003301
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- Publication type:
- Article
Pathways in the Drug Development for Alzheimer's Disease (1906-2016): A Bibliometric Study.
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- Journal of Scientometric Research, 2020, v. 9, n. 3, p. 277, doi. 10.5530/jscires.9.3.35
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- Article
Correction: A standardised framework to identify optimal animal models for efficacy assessment in drug development.
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- PLoS ONE, 2019, v. 14, n. 7, p. 1, doi. 10.1371/journal.pone.0220325
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- Publication type:
- Article
A standardised framework to identify optimal animal models for efficacy assessment in drug development.
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- PLoS ONE, 2019, v. 14, n. 6, p. 1, doi. 10.1371/journal.pone.0218014
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- Publication type:
- Article
Immunogenicity of Innovative and Biosimilar Monoclonal Antibodies.
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- Antibodies (2073-4468), 2019, v. 8, n. 1, p. 21, doi. 10.3390/antib8010021
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- Publication type:
- Article
Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product.
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- Pharmaceutical Research, 2018, v. 35, n. 11, p. 1, doi. 10.1007/s11095-018-2491-5
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- Publication type:
- Article
Erratum: Making individualized drugs a reality.
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- Nature Biotechnology, 2017, v. 35, n. 8, p. 797, doi. 10.1038/nbt0817-797c
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- Article
Making individualized drugs a reality.
- Published in:
- Nature Biotechnology, 2017, v. 35, n. 6, p. 507, doi. 10.1038/nbt.3888
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- Publication type:
- Article
Hybrid mass spectrometry approaches in glycoprotein analysis and their usage in scoring biosimilarity.
- Published in:
- Nature Communications, 2016, v. 7, n. 11, p. 13397, doi. 10.1038/ncomms13397
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- Article
The constrained prescription, interchangeability and substitution of biosimilars.
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- Nature Biotechnology, 2015, v. 33, n. 7, p. 688, doi. 10.1038/nbt.3272
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- Article
Biosimilars or semi-similars?
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- Nature Biotechnology, 2015, v. 33, n. 1, p. 19, doi. 10.1038/nbt.3083
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- Publication type:
- Article
Effect of Arginine on Pre-nucleus Stage of Interferon Beta-1b Aggregation.
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- AAPS PharmSciTech, 2014, v. 15, n. 6, p. 1619, doi. 10.1208/s12249-014-0192-x
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- Publication type:
- Article
How Bio-questionable are the Different Recombinant Human Erythropoietin Copy Products in Thailand?
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- Pharmaceutical Research, 2014, v. 31, n. 5, p. 1210, doi. 10.1007/s11095-013-1243-9
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- Publication type:
- Article
What's in a name?
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- Nature Biotechnology, 2014, v. 32, n. 2, p. 132, doi. 10.1038/nbt.2819
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- Publication type:
- Article
Different Pharmaceutical Products Need Similar Terminology.
- Published in:
- AAPS Journal, 2014, v. 16, n. 1, p. 11, doi. 10.1208/s12248-013-9532-0
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- Publication type:
- Article
How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider.
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- AAPS Journal, 2014, v. 16, n. 1, p. 15, doi. 10.1208/s12248-013-9533-z
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- Publication type:
- Article
Influence of Aggregation and Route of Injection on the Biodistribution of Mouse Serum Albumin.
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- PLoS ONE, 2014, v. 9, n. 1, p. 1, doi. 10.1371/journal.pone.0085281
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- Article
The Immunogenicity of Polyethylene Glycol: Facts and Fiction.
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- Pharmaceutical Research, 2013, v. 30, n. 7, p. 1729, doi. 10.1007/s11095-013-1067-7
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- Publication type:
- Article
Effect of Treatment Regimen on the Immunogenicity of Human Interferon Beta in Immune Tolerant Mice.
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- Pharmaceutical Research, 2013, v. 30, n. 6, p. 1553, doi. 10.1007/s11095-013-0992-9
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- Publication type:
- Article
Differences Between Post-Authorization Adverse Drug Reactions of Biopharmaceuticals and Small Molecules.
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- BioDrugs, 2013, v. 27, n. 2, p. 167, doi. 10.1007/s40259-013-0012-y
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- Publication type:
- Article
The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals.
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- European Journal of Clinical Pharmacology, 2013, v. 69, n. 2, p. 217, doi. 10.1007/s00228-012-1317-3
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- Publication type:
- Article
Antibody Response Against Betaferon® in Immune Tolerant Mice: Involvement of Marginal Zone B-cells and CD4+ T-cells and Apparent Lack of Immunological Memory.
- Published in:
- Journal of Clinical Immunology, 2013, v. 33, n. 1, p. 255, doi. 10.1007/s10875-012-9783-z
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- Publication type:
- Article
Interchangeability, immunogenicity and biosimilars.
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- Nature Biotechnology, 2012, v. 30, n. 12, p. 1186, doi. 10.1038/nbt.2438
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- Publication type:
- Article
A cohort study exploring determinants of safety-related regulatory actions for biopharmaceuticals.
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- 2012
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- Publication type:
- journal article
Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights.
- Published in:
- Kidney International, 2012, v. 81, n. 8, p. 727, doi. 10.1038/ki.2011.500
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- Publication type:
- Article
Willingness to Pay for Adverse Drug Event Regulatory Actions.
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- PharmacoEconomics, 2011, v. 29, n. 11, p. 963, doi. 10.2165/11539860-000000000-00000
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- Publication type:
- Article
Immunogenicity of Therapeutic Proteins: The Use of Animal Models.
- Published in:
- Pharmaceutical Research, 2011, v. 28, n. 10, p. 2379, doi. 10.1007/s11095-011-0523-5
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- Publication type:
- Article
Oxidized and Aggregated Recombinant Human Interferon Beta is Immunogenic in Human Interferon Beta Transgenic Mice.
- Published in:
- Pharmaceutical Research, 2011, v. 28, n. 10, p. 2393, doi. 10.1007/s11095-011-0451-4
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- Publication type:
- Article
Biosimilars need comparative clinical data.
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- 2011
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- Publication type:
- Letter
Today's challenges in pharmacovigilance: what can we learn from epoetins?
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- 2011
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- Publication type:
- journal article
Quality of Original and Biosimilar Epoetin Products.
- Published in:
- Pharmaceutical Research, 2011, v. 28, n. 2, p. 386, doi. 10.1007/s11095-010-0288-2
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- Publication type:
- Article
Aggregated Recombinant Human Interferon Beta Induces Antibodies but No Memory in Immune-Tolerant Transgenic Mice.
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- Pharmaceutical Research, 2010, v. 27, n. 9, p. 1812, doi. 10.1007/s11095-010-0172-0
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- Publication type:
- Article
Reassessments of ESAs for Cancer Treatment in the US and Europe.
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- Oncology (08909091), 2010, v. 24, n. 3, p. 260
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- Publication type:
- Article
Clinical comparability and European biosimilar regulations.
- Published in:
- 2010
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- Publication type:
- Opinion
Hemoglobin variability in patients with chronic kidney disease in the Netherlands.
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- International Journal of Artificial Organs, 2009, v. 32, n. 11, p. 787, doi. 10.1177/039139880903201104
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- Publication type:
- Article
Immunological Risk of Injectable Drug Delivery Systems.
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- Pharmaceutical Research, 2009, v. 26, n. 6, p. 1303, doi. 10.1007/s11095-009-9855-9
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- Publication type:
- Article
Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union.
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- JAMA: Journal of the American Medical Association, 2008, v. 300, n. 16, p. 1887, doi. 10.1001/jama.300.16.1887
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- Publication type:
- Article
Recombinant human erythropoietins, biosimilars and immunogenicity.
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- Journal of Nephrology (JNonline), 2008, v. 21, n. 4, p. 497
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- Publication type:
- Article
The Rebif® New Formulation Story: It’s Not Trials and Error.
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- Drugs in R&D, 2007, v. 8, n. 6, p. 335, doi. 10.2165/00126839-200708060-00002
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- Publication type:
- Article
Lesson Learned from Eprex-Associated Pure Red Cell Aplasia.
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- Kidney & Blood Pressure Research, 2007, v. 30, n. S1, p. 9, doi. 10.1159/000107095
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- Publication type:
- Article
Immunogenicity of biopharmaceuticals.
- Published in:
- Nephrology Dialysis Transplantation, 2006, v. 21, p. v9, doi. 10.1093/ndt/gfl476
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- Publication type:
- Article
Neutralizing antibodies to interferon-beta may persist after cessation of therapy: what impact could they have?
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- Multiple Sclerosis (13524585), 2006, v. 12, n. 3, p. 245, doi. 10.1191/135248506ms1284ed
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- Publication type:
- Article
Eprex-associated pure red cell aplasia and leachates.
- Published in:
- 2006
- By:
- Publication type:
- Letter
Biosimilar Epoetins: An Analysis Based on Recently Implemented European Medicines Evaluation Agency Guidelines on Comparability of Biopharmaceutical Proteins.
- Published in:
- Pharmacotherapy, 2005, v. 25, n. 7, p. 954, doi. 10.1592/phco.2005.25.7.954
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- Publication type:
- Article
Antibodies against Erythropoietin and Other Protein-Based Therapeutics: An Overview.
- Published in:
- Annals of the New York Academy of Sciences, 2005, v. 1050, n. 1, p. 257, doi. 10.1196/annals.1313.027
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- Publication type:
- Article
Factors influencing the immunogenicity of therapeutic proteins.
- Published in:
- Nephrology Dialysis Transplantation, 2005, v. 20, p. vi3, doi. 10.1093/ndt/gfh1092
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- Publication type:
- Article
Follow-on biologics: challenges of the ‘next generation’.
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- Nephrology Dialysis Transplantation, 2005, v. 20, p. iv31, doi. 10.1093/ndt/gfh1085
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- Publication type:
- Article
Follow-on biologics: challenges of the next generation.
- Published in:
- Nephrology Dialysis Transplantation, 2005, v. 20, n. 4, p. iv31, doi. 10.1093/ndt/gfh1085
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- Publication type:
- Article
How similar do 'biosimilars' need to be?
- Published in:
- Nature Biotechnology, 2004, v. 22, n. 11, p. 1357, doi. 10.1038/nbt1104-1357
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- Publication type:
- Article