Keywords: Biotech drug; Small-molecule drug; R&D; Target therapy; Pricing; Biosimilar;
مقالات ISI (ترجمه نشده)
مقالات زیر هنوز به فارسی ترجمه نشده اند.
در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
Keywords: Monoclonal antibody; Biosimilar; Charge variant; LC-MS; N-glycan; Glycation; Deamidation; Sialylation;
Keywords: Biosimilar; Hormona de crecimiento; Déficit de hormona de crecimiento; rhGH; Biosimilar; Growth hormone; Growth hormone deficiency; rhGH;
Keywords: Inflammatory bowel disease; Ulcerative colitis; Biological therapy; Biosimilar; Infliximab; Adalimumab; CT-P13; Switching;
Keywords: Biologic; Biosimilar; Immunology; Rheumatology;
Keywords: LMWHs; Dalteparin; Porcine intestinal heparin; Bovine lung heparin; Ovine intestinal heparin; Biosimilar;
Keywords: Glycosylation; Glycoform; Nucleotide sugars; Biosimilar; Immune effector functions; mAbs; Therapeutic protein; Glutamine; Ammonia; Animal cell culture;
Keywords: ADA; anti-drug antibodies; CHMP; Committee for Medicinal Products for Human Use; DIN; Drug Identification Number; ECCO; European Crohn's and Colitis Organisation; EMA; European Medicines Agency; FDA; Food and Drug Administration; INN; International Nonp
Keywords: drug delivery systems; follow-on biologics; biocompatibility; bioequivalence; monoclonal antibody; regulatory approval and enforcement; biosimilar; BLA; BPCI;
Keywords: Biosimilar; Subsequent entry biologic; Reference biologic drug; Pharmaceutical practice; Biosimilaire; Produit biologique ultérieur; Produit biologique de référence; Pratique pharmaceutique;
Keywords: Human insulin; Oligomer; Ion mobility spectrometry; Mass spectrometry; Biosimilar; Biopharmaceuticals; ESI-IMS-MS; Electrospray ionization-ion mobility spectrometry-mass spectrometry; MALDI; matrix-assisted laser desorption and ionization; TOF; time of fl
Keywords: Infliximab; Biosimilar; TNF-α; Rheumatoid arthritis; anti-TNF-α; Therapeutic mAb;
Keywords: Biosimilar; Interchangeability; Biosimilarity; Regulatory; Endocrine;
Keywords: Monoclonal antibody; Biosimilar; Clone selection; Protein A; Two-dimensional liquid chromatography;
Keywords: Biosimilar; Survey; Pharmacists; General practitioners; Medical specialists; Physicians; Awareness; Attitudes; BSG; British Society of Gastroenterology; EC; European Commission; EMA; European Medicines Agency; EPAR; European Public Assessment Report; Fime
Keywords: Innovator biologic agent; Biosimilar; Post-translational protein modifications; Indication extrapolation
Keywords: Human growth hormone; r-hGH; Biosimilar; Genotropin; Bioequivalence;
Keywords: Biosimilar; Biological product; Oncology; Cancer;
Keywords: Biologic; Biosimilar; Biosimilarity; Characterization; Chronic inflammatory diseases; Clinical; Comparability; Development; Functional; Immunogenicity; Innovator; Manufacturing; Pharmacodynamics; Pharmacokinetics; Preclinical; Quality; Reference product;
Keywords: Access; Assessment; Biologic; Biosimilar; Cancer; Comorbidity; mAb; Older patients; Targeted therapy;
Keywords: Hydrogen/deuterium exchange (HDX); Top-down; Bottom-up; Antibody; Biosimilar;
Keywords: recombinant human erythropoietin; biosimilar; immunogenicity; physicochemical properties; protein characterization;
Keywords: Enfermedad inflamatoria intestinal; Enfermedad de Crohn; Colitis ulcerosa; Tratamiento; Inmunosupresores; Anti-TNF; Biosimilar; Vedolizumab; Tofacitinib; Células madre; Trasplante fecal; Inflammatory bowel disease; Crohn disease; Ulcerative colitis; Trea
Keywords: Biosimilar; Biologic; Innovator; Reference product; Chronic inflammatory diseases; Nomenclature; Biosimilarity; Regulatory guidance; Regulatory pathways; Generics; Small-molecule drugs; Development
Keywords: biosimilar; epoetin alfa; equivalence; erythropoietin; pharmacokinetics; pharmacodynamics;
Keywords: Inflammatory bowel disease; Crohn's disease; Ulcerative colitis; Biological agents; Vedolizumab; Golimumab; BiosimilarEnfermedad inflamatoria intestinal; Enfermedad de Crohn; Colitis ulcerosa; Biológicos; Vedolizumab; Golimumab; Biosimilar
Keywords: Monoclonal antibodies; Biosimilar; Fc-fusion protein; Antibody; Drug conjugate; Capillary gel electrophoresis; Capillary zone; Electrophoresis; Capillary isoelectric focusing; Mass spectrometry;
Keywords: 2D-LC; two-dimensional liquid chromatography; AA; amino acid; AC; affinity chromatography; ADC; antibody-drug conjugates; ADCC; antibody-dependent cellular cytotoxicity; AF4; asymmetric flow field fractionation; APTS; 1-aminopyrene-3,6,8-trisulfonate; Asn
Keywords: Comparability; Biosimilar; Screening; Sensorgram comparison; Fc receptor; SPR; SPR; surface plasmon resonance; HEK; human embryonic kidney; min/max; minimum/maximum; SD; standard deviation(s); SSQ; sum of squares;
Keywords: Biosimilar; Extrapolation; Inflammatory Bowel Disease; CT-P13; Infliximab; Infliximab-dyyb; ADA; anti-drug antibody; ADCC; antibody-dependent cell cytotoxicity; AS; ankylosing spondylitis; CD; Crohn's disease; CRP; C-reactive protein; EMA; European Medi
Keywords: Biosimilar; Biological agents;
Keywords: Eprex; Pastopoitin; Anemia; Hemodialysis; Biosimilar
Keywords: Psoriasis; Biosimilar; Biologic; Clinical trials; Interchangeability; Substitution; Legislation; Infliximab; Etanercept; AdalimumabPsoriasis; Biosimilar; Biológico; Ensayos clínicos; Intercambiabilidad; Sustitución; Legislación; Infliximab; Etanercept; Ad
Keywords: biosimilar; biologic; guidelines; clinical practice; inflammatory disorders; innovator; reference product; interchangeability; comparability; immunogenicity; extrapolation; pharmacokinetics; pharmacodynamics; pharmacovigilance; regulations; naming; labeli
Keywords: Biosimilar; biologic; reference product; chronic inflammatory diseases; clinical studies, comparability; immunogenicity, extrapolation; pharmacokinetics; pharmacodynamics; regulatory guidances; study design; safety;
Keywords: Biopharmaceutical; Biosimilar; Capillary electrophoresis coupled to mass spectrometry (CE-MS); Glycomics; Glycoproteomics; Glycosylation Critical Quality Attributes (GCQA); Liquid chromatography coupled to mass spectrometry (LC-MS); Matrix-assisted laser
Keywords: Biosimilar; Clinical assessment; Equivalence; Extrapolation; Similar biotherapeutic products; WHO
Keywords: Biopharmaceutical; Biosimilar; Darbepoetin alfa; Epoetin; Glycan; Glycomic characterization; Glycopeptide; Glycosylation; Mass spectrometry; Recombinant erythropoietin;
Keywords: biopharmaceuticals characterization; biosimilar; excipients; injectables; lyophilization; oxidation; protein aggregation; proteinformulation; protein structure; solid state;
Keywords: Biosimilar; Extrapolation; Tumor necrosis factor alpha; Infliximab; Authorization; Safety
Keywords: Biosimilar; Similar biotherapeutic products; WHO; Xiamen case study; Quality assessment
Keywords: Biosimilar; Specialty pharmaceuticals; Health care cost; Follow-on biologic;
Keywords: biosimilar; biologic; biologics; Food and Drug Administration; interchangeability; substitution
Clinical safety and efficacy of “filgrastim biosimilar 2” in Japanese patients in a post-marketing surveillance study
Keywords: Filgrastim; Biosimilar; Post-marketing surveillance; Neutropenia;
Efficacy and safety of infliximab biosimilar Inflectra® in severe sarcoidosis
Keywords: Sarcoidosis; TNF-α inhibitor; Inflectra®; PET-scan; Biosimilar;
A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results
Keywords: Biosimilar; Trastuzumab; HER2; Early breast cancer; Event-free survival; Safety;
Systematic switch from innovator infliximab to biosimilar infliximab in inflammatory chronic diseases in daily clinical practice: The experience of Cochin University Hospital, Paris, France
Keywords: Infliximab; CT-P13; Biosimilar; Rheumatoid Arthritis; Axial Spondyloarthritis; Crohn's disease; Ulcerative Colitis; Uveitis; Switch;
Nonclinical assessments of the potential biosimilar PF-06439535 and bevacizumab
Keywords: Bevacizumab; PF-06439535; Biosimilar; Vascular endothelial growth factor; Nonclinical; Cynomolgus monkey; Sprague Dawley rat; ADA; antidrug antibody; AUC; area under the serum concentration-time curve; AUC0-72; area under the serum concentration-time
Pharmacokinetic and toxicology comparator testing of biosimilar drugs - Assessing need
Keywords: Biosimilar; Innovator; Pharmacokinetic testing; Toxicology testing; Comparability exercise; Regulatory guidance;
Ranibizumab biosimilar/polyethyleneglycol-conjugated gold nanoparticles as a novel drug delivery platform for age-related macular degeneration
Keywords: Age-related macular degeneration; Biosimilar; Gold nanoparticles; PEGylation; Ranibizumab;