دانلود مقالات ISI درباره Biosimilar + ترجمه فارسی

Biosimilars to recombinant human FSH medicines: comparable efficacy and safety to the original biologic

Keywords: Biological; Biosimilar; Follicle-stimulating hormone; Follitropin; Interchangeability; Similar biological medicine;

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2017 سفارش ترجمه

Safety and Biosimilarity of ior®LeukoCIM Compared to Neupogen® Based on Toxicity, Pharmacodynamic, and Pharmacokinetic Studies in the Sprague-Dawley Rat

Keywords: biosimilar; filgrastim; ior®LeukoCIM; pharmacodynamic; pharmacokinetic; safety;

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2017 سفارش ترجمه

Chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim in elderly versus non-elderly cancer patients: Patterns, outcomes, and determinants (MONITOR-GCSF study)

Keywords: Geriatric; Elderly; Neutropenia; Granulocyte colony-stimulating factor; Filgrastim; Biosimilar;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2017 سفارش ترجمه

Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study

Keywords: ABP 501; adalimumab; biosimilar; efficacy; equivalence; psoriasis; safety; ADA; antidrug antibody; CI; confidence interval; PASI; Psoriasis Area and Severity Index; PASI 50; 50% or more improvement in Psoriasis Area and Severity Index score from baseline;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2017 سفارش ترجمه

Evolución tras el intercambio a infliximab biosimilar en pacientes con enfermedad inflamatoria intestinal en remisión clínica

Keywords: Infliximab; Biosimilar; CT-P13; Intercambio; Recidiva; Remisión; Infliximab, Biosimilar; CT-P13, Switching; Relapse; Remission;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2017 سفارش ترجمه

In Vivo Effect of Innate Immune Response Modulating Impurities on the Skin Milieu Using a Macaque Model: Impact on Product Immunogenicity

Keywords: biosimilar; biotechnology; immunology; immune response; injectables; skin;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2017 سفارش ترجمه

Surrogate CD16-expressing effector cell lines for determining the bioactivity of therapeutic monoclonal antibodies

Keywords: ADCC; Luciferase reporter gene assays; Monoclonal antibodies; Biosimilar; Effector function;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2017 سفارش ترجمه

Charge variant analysis of proposed biosimilar to Trastuzumab

Keywords: Biosimilar; Charge variants; Binding kinetics; In vitro potency;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2017 سفارش ترجمه

A demonstration of analytical similarity comparing a proposed biosimilar pegfilgrastim and reference pegfilgrastim

Keywords: biosimilar; Filgrastim; Pegfilgrastim; Analytical comparability; Granulocyte-colony stimulating factor; Neutropenia; anc; absolute neutrophil count; BFU-E; Burst-Forming Unit - Erythroid; BPCIA; Biologics Price Competition and Innovation Act; CD; circul

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2017 سفارش ترجمه

Efficacy, safety and pharmacokinetics of biosimilars of anti-tumor necrosis factor-α agents in rheumatic diseases; A systematic review and meta-analysis

Keywords: Biosimilar; Anti-TNF-α; Immune mediated disease; Systematic review; Meta-analysis;

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2017 سفارش ترجمه

One-month stability study of a biosimilar of infliximab (Remsima®) after dilution and storage at 4 Â°C and 25 Â°C

Keywords: Monocolonal antibody; Biosimilar; Physical stabililty; Chemical stability; “In-use” conditions; Anticorps monoclonal; Biosimilaire; Stabilité physique; Stabilité chimique; Conditions d'utilisation;

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2017 سفارش ترجمه

Extended stability of the rituximab biosimilar CT-P10 in its opened vials and after dilution and storage in polyolefin bags

Keywords: Rituximab; Biosimilar; CT-P10; Extended stability; In-use; Rituximab; Biosimilaire; CT-P10; Stabilité étendue; Utilisation d'usage;

دانلود رایگان متن کامل مقاله ISI 16 صفحه سال انتشار : 2017 سفارش ترجمه

The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis

Keywords: biosimilar; CT-P13; infliximab; psoriasis; Remicade; Remsima;

دانلود رایگان متن کامل مقاله ISI 4 صفحه سال انتشار : 2016 سفارش ترجمه

Serum trough infliximab levels: A comparison of three different immunoassays for the monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease

Keywords: Infliximab; Biosimilar; CT-P13; Inflammatory bowel disease; Enzyme-linked immunosorbent assay;

دانلود رایگان متن کامل مقاله ISI 4 صفحه سال انتشار : 2016 سفارش ترجمه

Juego de patentes. Sobre medicamentos genéricos y biosimilares

Keywords: Patente; Medicamentos genéricos; Biosimilares; Normativa; Eficiencia; Patent; Drugs generic; Biosimilar; Regulation; Efficiency;

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2016 سفارش ترجمه

Biosimilars: Extrapolation for oncology

Keywords: Cancer; Extrapolation; Biosimilar; Monoclonal antibody;

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2016 سفارش ترجمه

Biosimilar Filgrastim (Tevagrastim, XMO2) for Allogeneic Hematopoietic Stem Cell Mobilization and Transplantation in Patients with Acute Myelogenous Leukemia/Myelodysplastic Syndromes

Keywords: Biosimilar; Granulocyte colony-stimulating factor (G-CSF); Allogeneic hematopoietic stem transplantation; Normal donors; Siblings; Myelodysplastic syndromes; Acute myelogenous leukemia;

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2016 سفارش ترجمه

Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health

Keywords: Biosimilar; Switching; Interchangeability; Safety; Infliximab; Immunogenicity;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2016 سفارش ترجمه

Introduction of Biosimilar Therapeutics Into Nephrology Practice in the United States: Report of a Scientific Workshop Sponsored by the National Kidney Foundation

Keywords: Biosimilar; biologic; erythropoietin analogue; dialysis; regulatory; therapeutic equivalency; reference agent; drug approval; safety; efficacy; cost; anemia; nephrology; end-stage renal disease (ESRD); pharmacovigilance; interchangeability;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2016 سفارش ترجمه

CommentaryBiosimilars: A consideration of the regulations in the United States and European union

Keywords: Biosimilar; Pharmacovigilance; Extrapolation; Interchangeability; Regulation; US Food and Drug Administration; (FDA); European Medicines Agency; (EMA); Europe; (EU); United States; (US); International Nonproprietary Name; (INN); World Health Organization;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2016 سفارش ترجمه

Understanding the biosimilar approval and extrapolation process-A case study of an epoetin biosimilar

Keywords: Biosimilar; Erythropoietin-stimulating agent; Comparability; Extrapolation; Retacrit™;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2016 سفارش ترجمه

Evaluation of calibration-free concentration analysis provided by Biacore™ systems

Keywords: CFCA; SPR; Biosimilar; BiacoreSPR, surface plasmon resonance; MTL, mass transport limitation; CFCA, calibration free concentration analysis; km, mass transport coefficient; RU, resonance units; D, diffusion coefficient; PGSE, pulsed-gradient spin-echo; NM

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2016 سفارش ترجمه

Pharmacodynamic and Pharmacokinetic Equivalences of Epoetin Hospira and Epogen® After Multiple Subcutaneous Doses to Healthy Male Subjects

Keywords: biosimilar; epoetin alfa; equivalence; erythropoietin; pharmacodynamics pharmacokinetics;

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2016 سفارش ترجمه

ReviewHydrogen deuterium exchange mass spectrometry in biopharmaceutical discovery and development - A review

Keywords: Hydrogen deuterium exchange; Mass spectrometry; Drug discovery and development; Protein therapeutics; Biosimilar; Biopharmaceutical industry;

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2016 سفارش ترجمه

Comparative Evaluation of the Chemical Stability of 4 Well-Defined Immunoglobulin G1-Fc Glycoforms

Keywords: antibody; biosimilar; glycoform; oxidation; stability; UV light; H2O2; metal; peroxide;

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2016 سفارش ترجمه

Nuevas moléculas en el tratamiento de la enfermedad inflamatoria intestinal

Keywords: Enfermedad inflamatoria intestinal; Enfermedad de Crohn; Colitis ulcerosa; Biológicos; Vedolizumab; Golimumab; BiosimilarInflammatory bowel disease; Crohn's disease; Ulcerative colitis; Biological agents; Vedolizumab; Golimumab; Biosimilar

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2016 سفارش ترجمه

Production, Characterization, and Biological Evaluation of Well-Defined IgG1 Fc Glycoforms as a Model System for Biosimilarity Analysis

Keywords: IgG antibody; glycoprotein; glycosylation; receptors; biopharmaceuticals characterization; follow-on biologics; biosimilar;

دانلود رایگان متن کامل مقاله ISI 16 صفحه سال انتشار : 2016 سفارش ترجمه

Tbo-Filgrastim versus Filgrastim during Mobilization and Neutrophil Engraftment for Autologous Stem Cell Transplantation

Keywords: Biosimilar; Tbo-filgrastim; Granulocyte colony-stimulating factor; Mobilization; Engraftment;

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2015 سفارش ترجمه

Biosimilares en dermatología. Situación actual (parte ii)

Keywords: Psoriasis; Biosimilar; Biológico; Ensayos clínicos; Intercambiabilidad; Sustitución; Legislación; Infliximab; Etanercept; Adalimumab; Psoriasis; Biosimilar; Biologic; Clinical trials; Interchangeability; Substitution; Legislation; Infliximab; Etanerce

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2015 سفارش ترجمه

Biosimilares en dermatología. Situación actual (parte i)

Keywords: Psoriasis; Biosimilar; Biológico; Ensayos clínicos; Intercambiabilidad; Sustitución; Legislación; Infliximab; Etanercept; AdalimumabPsoriasis; Biosimilar; Biologic; Clinical trials; Interchangeability; Substitution; Legislation; Infliximab; Etanercept; Ad

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2015 سفارش ترجمه

The Emerging Role of Biosimilar Epoetins in Nephrology in the United States

Keywords: Biologic; biosimilar; bioequivalent drug; epoetin; epoetin alfa; epoetin zeta; recombinant human erythropoietin (rHuEPO); erythropoiesis-stimulating agent (ESA); anemia; chronic kidney disease (CKD); economics; safety; Retacrit;

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2015 سفارش ترجمه

Host Cell Proteins: The Hidden Side of Biosimilarity Assessment

Keywords: biotechnology; glycoprotein; immunology; biosimilar; cell culture; comparability; PLBL2; analytical biochemistry; host cell proteins; ELISA;

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2015 سفارش ترجمه

Evaluation of the physicochemical and functional stability of diluted REMSIMA® upon extended storage-A study compliant with NHS (UK) guidance

Keywords: Remsima; Infliximab; Biosimilar; Antibody; Shelf-life; Extended storage; Compliance; Stability study;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2015 سفارش ترجمه

Establishment of the first international standard for PEGylated granulocyte colony stimulating factor (PEG-G-CSF): Report of an international collaborative study

Keywords: Biosimilar; Biological activity; International standard; Modified G-CSF;

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2015 سفارش ترجمه

Potential Cost Savings From Chemotherapy-Induced Febrile Neutropenia With Biosimilar Filgrastim and Expanded Access to Targeted Antineoplastic Treatment Across the European Union G5 Countries: A Simulation Study

Keywords: biosimilar; budget impact; cost savings; febrile neutropenia; granulocyte colony-stimulating factor;

دانلود رایگان متن کامل مقاله ISI 16 صفحه سال انتشار : 2015 سفارش ترجمه

Antibody Glycosylation and Its Impact on the Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies and Fc-Fusion Proteins

Keywords: mAb; glycosylation; Fc-fusion; pharmacokinetics; pharmacodynamics; ADCC; CDC; biosimilar; immunogenicity

دانلود رایگان متن کامل مقاله ISI 19 صفحه سال انتشار : 2015 سفارش ترجمه

Targeted biopharmaceuticals for cancer treatment

Keywords: Anticancer biopharmaceuticals; Targeted therapy; Innovative biologics; Biosimilar;

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2014 سفارش ترجمه

Safety and Biosimilarity of ior®EPOCIM Compared with Eprex® Based on Toxicologic, Pharmacodynamic, and Pharmacokinetic Studies in the Sprague-Dawley Rat

Keywords: Erythropoietin; biosimilar; ior®EPOCIM; Eprex®; toxicity; pharmacokinetic; pharmacodynamic; safety; toxicokinetics; bioequivalence;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2014 سفارش ترجمه

Mass spectrometric glycoform profiling of the innovator and biosimilar erythropoietin and darbepoetin by LC/ESI-MS

Keywords: Recombinant erythropoietin; Biosimilar; Glycoform profile; Mass spectrometry; LC/ESI-MS;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2013 سفارش ترجمه

Heteronuclear NMR provides an accurate assessment of therapeutic insulin's quality

Keywords: SOFAST; band-selective optimized-flip-angle short-transient; HMQC; heteronuclear multiple quantum coherence; HSQC; heteronuclear single quantum correlation; EMEA; European Medicine Agency; SOFAST NMR; Insulin; Lispro; Biodrug; Biosimilar;

دانلود رایگان متن کامل مقاله ISI 17 صفحه سال انتشار : 2013 سفارش ترجمه

Medicamentos biocomparables en México: la postura del Colegio Mexicano de Reumatología, 2012

Keywords: Biosimilar; Biocomparable; Artritis reumatoide; Biológicos; Biotecnológicos; Fármacos innovadores; Biosimilar; Biocomparable; Rheumatoid arthritis; Biologic; Biotechnological; Innovator drugs;

دانلود رایگان متن کامل مقاله ISI 4 صفحه سال انتشار : 2013 سفارش ترجمه

Biosimilar Drugs in Mexico: Position of the Mexican College of Rheumatology, 2012

Keywords: Biosimilar; Biocomparable; Rheumatoid arthritis; Biologic; Biotechnological; Innovator drugsBiosimilar; Biocomparable; Artritis Reumatoide; Biológicos; Biotecnológicos; Fármacos innovadores

دانلود رایگان متن کامل مقاله ISI 4 صفحه سال انتشار : 2013 سفارش ترجمه

Conceptos básicos sobre los fármacos biológicos

Keywords: Biotecnología; Biosimilar; Terapéutica; Oncología; Artritis reumatoide; Eficiencia.;

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2013 سفارش ترجمه

Evaluating the inter and intra batch variability of protein aggregation behaviour using Taylor dispersion analysis and dynamic light scattering

Keywords: Taylor dispersion analysis; Hydrodynamic radius; Dynamic light scattering; Aggregation; Biosimilar

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2013 سفارش ترجمه

Tackling the increasing complexity of therapeutic monoclonal antibodies with mass spectrometry

Keywords: Analytical method; Antibody (Ab); Antibody-drug conjugate (ADC); Biopharmaceutical; Biosimilar; Bispecific antibody; Glycosylation; Mass spectrometry; Native mass spectrometry; Sequence variant

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2013 سفارش ترجمه

Top-down characterization of biopharmaceuticals

Keywords: Biopharmaceutical; Biosimilar; Deamidation; Fragmentation; Glycoprotein; Glycosylation; Ionization; Mass spectrometry (MS); Protein characterization; Top-down analysisCID, Collision-induced dissociation; ESI, Electrospray ionization; FT-ICR, Fourier trans

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2013 سفارش ترجمه

A global comparability approach for biosimilar monoclonal antibodies using LC–tandem MS based proteomics

Keywords: Biosimilar; Proteomics; LC–MS; Comparability study; Trastuzumab

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2013 سفارش ترجمه

Characterization of biopharmaceuticals by NMR spectroscopy

Keywords: Biopharmaceuticals; Biosimilar; Characterization; Formulation; Nuclear magnetic resonance (NMR); Oligonucleotide; Peptide; Polysaccharide; Protein; Quality control

دانلود رایگان متن کامل مقاله ISI 16 صفحه سال انتشار : 2013 سفارش ترجمه

Biosimilar DMARD in rheumatology: A general perspective with focus on India

Keywords: Biologic; Biosimilar; DMARD; Rheumatoid arthritis;

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2012 سفارش ترجمه

Effect of process change from perfusion to fed-batch on product comparability for biosimilar monoclonal antibody

Keywords: Biosimilar; Comparability; Fed-batch; Monoclonal antibody; Perfusion process;

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2012 سفارش ترجمه