دانلود مقالات ISI درباره آژانس دارویی اروپا + ترجمه فارسی

ReviewNanocarriers for intravenous injection-The long hard road to the market

Keywords: آژانس دارویی اروپا; API; active pharmaceutical ingredient; CARPA; complement activation-related pseudoallergy; DLS; dynamic light scattering; EMA; European Medicines Agency; EPR; enhanced permeation and retention; EU; European Union; FDA; Food and Drug Administration; GMP; G

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2013 سفارش ترجمه

Exploring the Relationships Between Scaled Bioequivalence Limits and Within-Subject Variability

Keywords: آژانس دارویی اروپا; bioequivalence; bioavailability; scaled limits; highly variable drugs; European Medicines Agency; Food and Drug Administration; mathematical models; regulatory science; pharmacokinetics; relative change;

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2013 سفارش ترجمه

The European Medicines Agency review of vemurafenib (Zelboraf®) for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma: Summary of the scientific assessment of the Committee for Medicinal Products for Huma

Keywords: آژانس دارویی اروپا; Vemurafenib; Melanoma; EMA; European Medicines Agency

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2013 سفارش ترجمه

The development and validation of an immunoassay for the measurement of anti-thymidine phosphorylase antibodies in mouse and dog sera

Keywords: آژانس دارویی اروپا; Anti-TP; anti-thymidine phosphorylase; CF; correction factor; CV; coefficient of variation; ECL; electrochemiluminescent; EE-TP; erythrocyte encapsulated thymidine phosphorylase; EMA; European Medicines Agency; FDA; Food and Drug Administration; GLP; Good

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

Analysis of the landscape of biologically-derived pharmaceuticals in Europe: Dominant production systems, molecule types on the rise and approval trends

Keywords: آژانس دارویی اروپا; European medicines agency; Host cells; Therapeutic molecule class; Therapeutic area; rDNA drugs; Biosimilars

دانلود رایگان متن کامل مقاله ISI 14 صفحه سال انتشار : 2013 سفارش ترجمه

The New Oral Anticoagulants in Clinical Practice

Keywords: آژانس دارویی اروپا; AF; atrial fibrillation; AMPLIFY-EXT; Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy-Extended Treatment; aPTT; activated partial thromboplastin time; ARISTOTLE; Apixaban for Reduction in Stro

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

New antibiotics for paediatric use: A review of a decade of regulatory trials submitted to the European Medicines Agency from 2000—Why aren’t we doing better?

Keywords: آژانس دارویی اروپا; Clinical trial; Paediatrics; Neonates; Off-label use; Antibiotics; European Medicines Agency

دانلود رایگان متن کامل مقاله ISI 20 صفحه سال انتشار : 2013 سفارش ترجمه

The US FDAs withdrawal of the breast cancer indication for Avastin (bevacizumab)

Keywords: آژانس دارویی اروپا; Bevacizumab; Breast cancer; Indication withdrawn; FDA; Unpublished analyses; FDA briefing documents; European Medicines Agency

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2012 سفارش ترجمه

CommentaryBiopharmaceuticals and biosimilars in psoriasis: What the dermatologist needs to know

Keywords: آژانس دارویی اروپا; bioequivalence; biologics; biopharmaceuticals; biosimilars; follow-on biologics; generics; pharmacokinetics; psoriasis; EMA; European Medicines Agency; EPO; erythropoietin; FDA; Food and Drug Administration; TNF; tumor necrosis factor;

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2012 سفارش ترجمه

The European Medicines Agency review of ipilimumab (Yervoy) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy: Summary of the scientific assessment of the Committee for Medicinal Products for Hum

Keywords: آژانس دارویی اروپا; Ipilimumab; Melanoma; EMA; European Medicines Agency;

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2012 سفارش ترجمه

Translating vaccine policy into action: A report from the Bill & Melinda Gates Foundation Consultation on the prevention of maternal and early infant influenza in resource-limited settings

Keywords: آژانس دارویی اروپا; AEFI; adverse event following immunization; ALRI; acute lower respiratory infections; EMA; European Medicines Agency; EPI; Expanded Programme on Immunization; FDA; United States Food and Drug Administration; GACVS; WHO Global Advisory Committee on Vaccine

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2012 سفارش ترجمه

A pre-marketing ALT signal predicts post-marketing liver safety

Keywords: آژانس دارویی اروپا; DILI; drug induced liver injury; FDA; Food and Drug Administration; AERS; Adverse Event Reporting System; ALT; alanine aminotransferase; ULN; upper limit of normal; NDA; new drug application; EMA; European Medicines Agency; PDR; Physician's Desk Referen

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2012 سفارش ترجمه

Le renforcement du système de pharmacovigilance de l'Union européenne. (Analyse du nouveau cadre réglementaire issu des dispositions de la directive 2010/84/UE et du règlement [UE] no 1235/2010)

Keywords: آژانس دارویی اروپا; Médicament à usage humain (pharmacovigilance); Agence Européenne du Médicament; Pharmacovigilance; Medicinal Products for Human Use (pharmacovigilance); European Medicines Agency; Pharmacovigilance;

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2012 سفارش ترجمه

Evaluation of sitaxentan (Thelin®) toxicity in juvenile rats and regulatory interactions during the development of a European Medicines Agency pediatric investigation plan

Keywords: آژانس دارویی اروپا; Sitaxentan; Juvenile; Rat; Toxicity; European Medicines Agency; Perinatal; Postnatal; Hepatotoxicity; Testicular toxicity; Pediatric investigation plan;

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

A prospective observational safety study on MF59® adjuvanted cell culture-derived vaccine, Celtura® during the A/H1N1 (2009) influenza pandemic

Keywords: آژانس دارویی اروپا; AE; adverse event; AESI; adverse event of special interest; CHMP; Committee for Medicinal Products for Human Use; EMA; European Medicines Agency; HLT; High Level Term; PT; Preferred Term; SAE; serious adverse event; SOC; System Organ Class; WHO; World Hea

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

Contribution of Modeling Approaches and Virtual Populations in Transposing the Results of Clinical Trials into Real Life and in Enlightening Public Health Decisions

Keywords: آژانس دارویی اروپا; modeling; simulation; clinical trials; public decision; virtual populations; CEPS; Economic committee of the health products in France (Comité économique des produits de santé); CTV; Technical committe of vaccinations in France (Comité technique des v

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

Testing strategies for embryo-fetal toxicity of human pharmaceuticals. Animal models vs. in vitro approaches

Keywords: آژانس دارویی اروپا; ICH; International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; REACH; Registration, Evaluation, Authorisation and restriction of Chemicals (Regulation (EC) No. 1907/2006); EST; embryonic stem cell tests; ECVAM;

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2012 سفارش ترجمه

Personalized Medicine: how to Switch from the Concept to the Integration into the Clinical Development Plan to Obtain Marketing Authorization

Keywords: آژانس دارویی اروپا; personalized medicine; biomarkers; phasis of development; economic model; Theranostic; DRESS syndrome; drug reaction with eosinophilia and systemic symptoms syndrom; EGFR; epidermal growth factor receptor; EMA; European Medicines Agency; FDA; Food and Dru

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2012 سفارش ترجمه

Monoclonal Antibodies for Therapeutic Use: Specific Characteristics of Clinical Development, Evaluation by the Agencies, and Long-term Monitoring of Safety

Keywords: آژانس دارویی اروپا; monoclonal antibodies; clinical trials, phase I; clinical trials, phase II; clinical trials, phase IV; ADCC; antibody dependent cellular cytotoxicity; (ex-)Afssaps; ex-Agence française de sécurité sanitaire des produits de santé (at present french Nat

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2012 سفارش ترجمه

Impurity profiling of capreomycin using dual liquid chromatography coupled to mass spectrometry

Keywords: آژانس دارویی اروپا; AA; Amino acid; ACN; Acetonitrile; arb; Arbitrary units; CMN; Capreomycin; CEL; Collision energy level; CID; Collision-induced dissociation; DAP; 2,3-diaminopropionic acid; EMA; European medicines agency; ESI; Electrospray ionization; FA; Formic acid; HIL

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2012 سفارش ترجمه

Fondaparinux - data on efficacy and safety in special situations

Keywords: آژانس دارویی اروپا; ACS; acute coronary syndrome; anti-Xa; anti-factor Xa activity; APS; antiphospholipid syndrome; BID; twice a day; BMI; body mass index; DVT; deep vein thrombosis; EMA; European Medicines Agency; FDA; U.S. Food and Drug Administration; FEIBA; factor eight

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2012 سفارش ترجمه

Emerging diabetes therapies and technologies

Keywords: آژانس دارویی اروپا; CSII; continuous subcutaneous insulin infusion; CGM; continuous glucose monitoring; DKA; diabetic ketoacidosis; DPP-IV; dipeptidyl peptidase-IV; EMEA; European Medicines Agency; FDA; Food and Drug Administration; FCL; fully closed-loop; GRAS; generally re

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2012 سفارش ترجمه

In vitro enrofloxacin binding in human fecal slurries

Keywords: آژانس دارویی اروپا; ADI; acceptable daily intakes; VICH; International Cooperation on Harmonization of Technical Requirements for Veterinary Medicinal Products; mADI; microbiological acceptable daily intakes; tADI; toxicological acceptable daily intakes; MIC; minimum inhibit

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2012 سفارش ترجمه

Comparisons of Food and Drug Administration and European Medicines Agency Risk Management Implementation for Recent Pharmaceutical Approvals: Report of the International Society for Pharmacoeconomics and Outcomes Research Risk Benefit Management Working G

Keywords: آژانس دارویی اروپا; European Medicines Agency; Food and Drug Administration; Pharmaceuticals; Risk benefit management

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2012 سفارش ترجمه

High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: A double-blind, placebo-controlled study

Keywords: آژانس دارویی اروپا; Sublingual immunotherapy; single-dose; high-dose; pre-/co-seasonal treatment; allergic rhinitis/rhinoconjunctivitis; children; double-blind placebo-controlled trial; efficacy; safety; grass pollen; AE; Adverse event; AUC; Area under the curve; DBPC; Doubl

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2012 سفارش ترجمه

Guide de la Haute autorité de santé (HAS) : les études post-inscription sur les technologies de santé (médicaments, dispositifs médicaux et actes) : principes et méthodes

Keywords: آژانس دارویی اروپا; évaluation des technologies de santé; études post-inscription; épidémiologie; méthodologie; conditions réelles d'utilisation; health technology assessment; post-registration studies; epidemiology; methodology; real-life study; Afssaps; Agence fra

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2012 سفارش ترجمه

Devices for intradermal vaccination

Keywords: آژانس دارویی اروپا; WHO; World Health Organisation; EMA; European Medicines Agency; CDSN device; Convergent-divergent supersonic nozzle device; CST devices; Contoured shock tube device; PMED; Particle-mediated epidermal delivery; EPI; Epidermal powder immunisation; CPMP; C

دانلود رایگان متن کامل مقاله ISI 16 صفحه سال انتشار : 2012 سفارش ترجمه

Devil's Claw-A review of the ethnobotany, phytochemistry and biological activity of Harpagophytum procumbens

Keywords: آژانس دارویی اروپا; 5-LOX; 5-lipo-oxygenase; 6′-PCHG; 6′-O-p-coumaroylharpagide; 8-PCHG; 8-p-coumaroylharpagide; BCL; Bicuculline; COX-2; cyclooxygenase-2; CREB; cAMP response element-binding; CYP; cytochrome P450; DAD; diode array detection; DPPH; 2, 2-diphenyl-1-picryl

دانلود رایگان متن کامل مقاله ISI 17 صفحه سال انتشار : 2012 سفارش ترجمه

Refined analysis of antigen-specific antibody responses - A new one-step tool in immunogenicity studies

Keywords: آژانس دارویی اروپا; APC; antigen presenting cells; BSA; bovine serum albumin; CI; confidence interval; CV%; coefficient of variation %; ELISA; enzyme linked immunosorbent assay; EMEA; European medicines agency; FDA; food and drug administration; FI; fluorescence intensity; H

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2011 سفارش ترجمه

Safety, tolerability, and immunogenicity of inactivated trivalent seasonal influenza vaccine administered with a needle-free disposable-syringe jet injector

Keywords: آژانس دارویی اروپا; AE; adverse event; CBC; complete blood count; CDC; centers for Disease Control and Prevention; CHMP; Committee for Human Medicinal Products; CI; confidence interval; DSJI; disposable-syringe jet injection/injector; EMEA; European Medicines Agency; FDA; U.

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2011 سفارش ترجمه

Development of a panel of highly sensitive, equivalent assays for detection of antibody responses to velaglucerase alfa or imiglucerase enzyme replacement therapy in patients with Gaucher disease

Keywords: آژانس دارویی اروپا; ADA; anti-drug antibody; BSA; bovine serum albumin; CPM; counts per minute; DPBS; Dulbecco's Phosphate Buffered Saline solution; ECL; electrochemiluminescence; EMA; European Medicines Agency; FDA; Food and Drug Administration; HBS-EP; HEPES-buffered salin

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2011 سفارش ترجمه

Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents

Keywords: آژانس دارویی اروپا; AE; adverse event; AS; Adjuvant System; AS03; tocopherol oil-in-water emulsion based Adjuvant System; ATP; according to protocol; BS; blood sampling; CHMP; Committee for Medicinal Products for Human Use; CI; confidence interval; EMA; European Medicines Ag

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2011 سفارش ترجمه

Perfil clínico y curso evolutivo de los pacientes tratados con efalizumab tras la suspensión de su autorización por la EMEA. Estudio observacional y multicéntrico

Keywords: آژانس دارویی اروپا; Efalizumab; EMEA; Rebote; Exacerbación inflamatoria generalizada; Efalizumab; European Medicines Agency; Rebound; Generalized inflammatory flare;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2011 سفارش ترجمه

Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 1—Eliciting Concepts for a New PRO Instrument

Keywords: آژانس دارویی اروپا; content validity; European Medicines Agency; Food and Drug Administration; patient reported outcomes; quality of life

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2011 سفارش ترجمه

Influenza vaccine for pregnant women in resource-constrained countries: A review of the evidence to inform policy decisions

Keywords: آژانس دارویی اروپا; ACIP; US Advisory Committee on Immunization Practices; ALRI; acute lower respiratory infections; EMEA; European Medicines Agency; FDA; US Food and Drug Administration; GACVS; WHO Global Advisory Committee on Vaccine Safety; HAI; serum hemagglutination inh

دانلود رایگان متن کامل مقاله ISI 14 صفحه سال انتشار : 2011 سفارش ترجمه

ESC/EAS Guidelines for the management of dyslipidaemias

Keywords: آژانس دارویی اروپا; 4D Die; Deutsche Diabetes Dialyse Studie; 4S; Scandinavian Simvastatin Survival Study; ABC-1; ATP-binding cassette transporter 1; ACCORD; Action to Control Cardiovascular Risk in Diabetes; ACS; acute coronary syndrome; AIM-HIGH; Atherothrombosis Intervent

دانلود رایگان متن کامل مقاله ISI 44 صفحه سال انتشار : 2011 سفارش ترجمه

Committee for Medicinal Products for Human Use (CHMP) assessment on efficacy of antidepressants

Keywords: آژانس دارویی اروپا; European Medicines Agency; EMEA; Committee for Medicinal Products for Human Use; CHMP; Antidepressants; Major depression; Drug evaluation

دانلود رایگان متن کامل مقاله ISI 4 صفحه سال انتشار : 2009 سفارش ترجمه

ReviewEthics in clinical research

Keywords: آژانس دارویی اروپا; RCT; randomized clinical trial; EMEA; European Medicines Agency; EU; European Union; DMARD; disease modifying anti-rheumatic drugs; Hb A1c; glycosylated hemoglobin; FDA; Food and Drug Administration; HDL; high-density lipoprotein; SSRI; selective serotoni

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2009 سفارش ترجمه

Medicines for Children: A Matter of Taste

Keywords: آژانس دارویی اروپا; EMEA; European Medicines Agency; VAS; Visual analogue scale;

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2008 سفارش ترجمه

PerspectiveCommentary on “Health economics and the value of therapy in Alzheimer's disease.” Value therapy for Alzheimer's disease-A European perspective

Keywords: آژانس دارویی اروپا; Alzheimer's; Dementia; Acetylcholinesterase inhibitor; Health economics; Cost effectiveness; European Medicines Agency; Treatment;

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2007 سفارش ترجمه

Reducción de la frecuencia cardiaca. Otras oportunidades terapéuticas

Keywords: آژانس دارویی اروپا; Frecuencia cardiaca; Riesgo cardiovascular; Isquemia miocárdica; Insuficiencia cardiaca; Canales If; Ivabradina; Heart rate; Cardiovascular risk; Myocardial ischemia; Heart failure; If channels; Ivabradine; AV; aurículo-ventricular; BEAUTIFUL; evaluatio

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2007 سفارش ترجمه

La prévision des effets indésirables des médicaments par des études non cliniques est-elle performante ?

Keywords: آژانس دارویی اروپا; Médicaments; Effets indésirables; Toxicité; Drugs; Adverse event; Toxicity; E.ME.A.; European Medicines Agency; H.E.S.I.; Health and Environmental Sciences Institute; I.C.H.International Conference on Harmonization; I.L.S.I.International Life Sciences

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2007 سفارش ترجمه

European Union centralised procedure for marketing authorisation of oncology drugs: An in-depth review of its efficiency

Keywords: آژانس دارویی اروپا; Centralised Procedure; European Medicines Agency; Marketing authorisation procedure; Oncology drugs; Orphan drugs

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2006 سفارش ترجمه