دانلود مقالات ISI درباره Chmp + ترجمه فارسی

ملاحظات کلیدی در تصمیم گیری بازپرداخت برای داروهای مولتیپل اسکلروزیس در استرالیا

Key considerations in reimbursement decision-making for multiple sclerosis drugs in Australia

Keywords: Multiple sclerosis; Pharmaceutical reimbursement, Decision-making; CHMP; committee for medicinal for human use; ICER; incremental cost-effectiveness ratio; MCID; minimal clinically important difference; MS; multiple sclerosis; PBAC; pharmaceutical benefit

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2018 سفارش ترجمه

مدل تنظیم مقررات اروپا برای طب گیاهی: ارزیابی مجله ی اتحادیه اروپا و ارزیابی ایمنی و اثربخشی در مجوز بازاریابی یا ثبت نام در کشورهای عضو

European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States

Keywords: European regulation model; HMP; EU monograph; TUR; WEU-MA; ESCOP; European Scientific Cooperative on Phytotherapy; WHO; World Health Organization; EU; European Union; HMPs; herbal medicinal products; WEU-MAs; marketing authorizations; TURs; traditional us

دانلود رایگان متن کامل مقاله ISI 20 صفحه سال انتشار : 2018 سفارش ترجمه

بیوسیمیلارها: مفاهیم و اختلافات

Biosimilars: Concepts and controversies

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

دانلود رایگان متن کامل مقاله ISI 61 صفحه سال انتشار : 2018 سفارش ترجمه

سیتوکینز سلول حیوانی: نقش تغییرات پویا در پروتئوم غشای پلاسما و لیپیدوم

Animal cell cytokinesis: The role of dynamic changes in the plasma membrane proteome and lipidome

Keywords: Cytokinesis; Centralspindlin; Anillin; ESCRT complex; Abscission; ALIX; apoptosis-linked gene-2 interacting protein X; ANCHR; abscission/NoCut Checkpoint Regulator; CHMP; charged multivesicular body protein; CPC; chromosome passenger complex; ESCRT; Endos

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

چشم انداز تنظیم کننده سلول درمان - دیدگاه اتحادیه اروپا

Regulatory landscape for cell therapy - EU view

Keywords: Advanced therapy medicinal products; Cell therapy; Clinical trials regulation; Committee for Advanced Therapies; European Medicines Agency; Marketing authorisation application; ATMP; advanced therapy medicinal products; CAT; Committee for Advanced Therapi

دانلود رایگان متن کامل مقاله ISI 4 صفحه سال انتشار : 2015 سفارش ترجمه

تنظیم داروهای سلول درمانی در کانادا

The regulation of cell therapy products in Canada

Keywords: Cell therapy; Minimally manipulated; Homologous use; Health Canada; Food and Drugs Act; Food and Drug Regulations; AHR Act; Assisted Human Reproduction Act of Canada; BGTD; Biologics and Genetic Therapies Directorate; CBER; Center for Biologics Evaluation

دانلود رایگان متن کامل مقاله ISI 4 صفحه سال انتشار : 2015 سفارش ترجمه

هدایت از طریق مقررات داروهای دارویی در اتحادیه اروپا و ایالات متحده - شباهت ها و تفاوت ها

Navigating through orphan medicinal product regulations in EU and US - Similarities and differences

Keywords: CFR; Code of Federal Regulations; CHMP; Committee for Medicinal Products for Human Use; COMP; Committee for Orphan Medicinal Products; EC; European Commission; EMA; European Medicines Agency; EU; European Union; FDA; Food and Drug Administration; MHLW; Mi

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

ایمنی و ایمنی واکسن جدید آنفلوانزا در بزرگسالان و سالمندان: یک کارآزمایی بالینی تصادفی

Immunogenicity and safety of the new intradermal influenza vaccine in adults and elderly: A randomized phase 1/2 clinical trial

Keywords: ID; intradermal; SC; subcutaneous; HA; hemagglutinin; HAI; hemagglutination inhibition; NT; microneutralization; GMT; geometrical mean titer; GMTR; GMT ratio; SCR; seroconversion ratio; SPR; seroprotection ratio; AE; adverse event; CHMP; The Committee for

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

آلومینیوم در ایمنوتراپی زیر جلدی خاص آلرژیک - چشم انداز آلمانی

Aluminium in allergen-specific subcutaneous immunotherapy - A German perspective

Keywords: SCIT; Subcutaneous Immunotherapy; EFSA; The European Food Safety Authority; TWI; Tolerable Weekly Intake; CHMP; Committee for Medical Products for Human use; EMA; European Medicine Agency; PDCO; The Paediatric Committee; MPL; Monophosphoryl Lipid A; PEI;

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2014 سفارش ترجمه

تاریخچه ژن درمانی

History of gene therapy

Keywords: ADA-SCID; adenosine deaminase deficiency; cDNA; complementary DNA; CHMP; Committee on Human Medicinal Products; DHFR; dihydrofolate reductase; DNA; deoxyribonucleic acid; E1; adenoviral gene; E1B 55K; adenoviral gene; EMA; European Medicines Agency; FDA;

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

Transitioning from first- to second-generation biosimilars: An appraisal of regulatory and post-marketing challenges

Keywords: ACR; American College of Rheumatology; ADAb; anti-drug antibody; ADCC; antibody-dependent cell-mediated cytotoxicity; AIFA; Italian Medicines Agency; CDC; complement-dependent cytotoxicity; CHMP; Committee for Medicinal Products for Human Use; DAS28; 28-j

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2018 سفارش ترجمه

ESCRT genes and regulation of developmental signaling

Keywords: ABA; abscisic acid; AUX1; AUXIN-RESISTANT1; CHMP; charged multivesicular body protein; Crb; crumbs; DSL; delta/serrate/lag-2; Dx; Deltex; Dome; domeless; Dpp; decapentaplegic; EGFR; epidermal growth factor receptor; ESCRT; endosomal sorting complex requir

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2018 سفارش ترجمه

The role of ESCRT during development and functioning of the nervous system

Keywords: ALIX; CHMP; Synapse; Cortex development;

دانلود رایگان متن کامل مقاله ISI 31 صفحه سال انتشار : 2018 سفارش ترجمه

Regulatory-accepted drug development tools are needed to accelerate innovative CNS disease treatments

Keywords: ACR; American College of Radiology; AD; Alzheimer disease; ADNI; Alzheimer's Disease Neuroimaging Initiative; ALS; Amyotrophic Lateral Sclerosis; ASD; Autism Spectrum Disorder; BBB; Blood-Brain-Barrier; BEST; Biomarkers, Endpoints and other Tools; BLA; Bi

دانلود رایگان متن کامل مقاله ISI 65 صفحه سال انتشار : 2018 سفارش ترجمه

Finding synergies for 3Rs - Toxicokinetics and read-across: Report from an EPAA partners' Forum

Keywords: Physiologically-based kinetic (PBK) modelling; Hazard and risk assessment; Weight-of-evidence (WoE); Threshold of toxicological concern (TTC); In vitro to in vivo extrapolation (IVIVE); Integrated approach for testing and assessment (IATA); Absorption; Di

دانلود رایگان متن کامل مقاله ISI 68 صفحه سال انتشار : 2018 سفارش ترجمه

Evaluation of a primary course of H9N2 vaccine with or without AS03 adjuvant in adults: A phase I/II randomized trial

Keywords: AE; adverse event; AESI; adverse event of specific interest; AS; adjuvant system; CBER; Center for Biologics Evaluation and Research; CHMP; Committee for Medicinal Products for Human Use; CI; confidence interval; EMA; European Medicines Agency; GMT; geome

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2017 سفارش ترجمه

Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in healthy adults: A phase I/II, observer-blind, randomized, controlled trial

Keywords: AE; adverse event; CBER; Center for Biologics Evaluation and Research; CHMP; Committee for Medical Products for Human Use; CI; confidence interval; GMT; geometric mean titers; HA; hemagglutinin; HI; hemagglutination-inhibition; MGI; mean geometric increas

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2017 سفارش ترجمه

Nonclinical pharmacology and toxicology of the first biosimilar insulin glargine drug product (BASAGLAR®/ABASAGLAR®) approved in the European Union

Keywords: Biosimilar insulin; Glucodynamics; Insulin glargine; Nonclinical; Pharmacokinetics; Pharmacology; Preclinical; Rats; Toxicology; ANOVA; analysis of variance; AUC0-24hr; exposure over 24-hour period; BHI; biosynthetic human insulin; CHMP; Committee on Me

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

Changing paradigms in bioequivalence trials submitted to the EMA for evaluation - A clinical and regulatory perspective

Keywords: EU; European Union; MA; marketing authorisation; BE; bioequivalence; BCS; Biopharmaceutics Classification System (BCS); CHMP; Committee for Medicinal Products for Human Use; NHS; National Health System; API; active pharmaceutical ingredient; EMA; European

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

Liquid chromatography-tandem mass spectrometric assay for the tyrosine kinase inhibitor afatinib in mouse plasma using salting-out liquid-liquid extraction

Keywords: AUC; area under the plasma concentration-time curve; CHMP; Committee for Medicinal Products for Human Use; EGFR; epidermal growth factor receptor; FDA; Food and Drug Administration; FVB; Friend Leukemia Virus; HER; human epidermal growth-factor receptor

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2016 سفارش ترجمه

Physicians prefer greater detail in the biosimilar label (SmPC) - Results of a survey across seven European countries

Keywords: Regulatory requirements; Biosimilars; Labelling survey; Physician preference; ASBM; Alliance for Safe Biologic Medicines; CHMP; Committee for Medicinal Products for Human Use; EMA; European Medicines Agency; EPAR; European Public Assessment Report; GaBI;

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

NMR Reveals the Interplay among the AMSH SH3 Binding Motif, STAM2, and Lys63-Linked Diubiquitin

Keywords: AMSH; associated molecule with the SH3 domain of STAM; AMSH-LP; AMSH-like protein; AMSH-SBM; SBM motif of AMSH; CHMP; charged multivesicular body proteins; CSP; chemical shift perturbation; ESCRT; endosomal sorting complexes required for transport; Hrs; h

دانلود رایگان متن کامل مقاله ISI 15 صفحه سال انتشار : 2016 سفارش ترجمه

Immunogenicity and safety of concomitant MF59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine administration in older adults

Keywords: aIIV3; adjuvanted trivalent inactivated influenza vaccine; IIV3; inactivated trivalent influenza vaccine; PPSV23; 23-valent pneumococcal polysaccharide vaccine; PCV13; 13-valent pneumococcal conjugate vaccine; HI; hemagglutination inhibition; GMT; geometr

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

Contribución de la Agencia Española de Medicamentos y Productos Sanitarios al Comité Europeo de Evaluación de Medicamentos de Uso Humano

Keywords: AEMPS; CHMP; EMA; Medicamentos de uso humano; Procedimiento centralizadoAEMPS; CHMP; EMA; Medicinal products for human use; Centralized procedure

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

Contribution of the Spanish Agency for Medicines and Healthcare Products to the European Committee for the Evaluation of Medicinal Products for Human Use

Keywords: AEMPS; CHMP; EMA; Medicinal products for human use; Centralized procedureAEMPS; CHMP; EMA; Medicamentos de uso humano; Procedimiento centralizado

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

Les médicaments orphelins : des opportunités méconnues pour les développeurs en Europe

Keywords: Orphan Drug Act; règlement 141/2000/CE; règlement d'éxécution 847/2000; Communication de la Commission (2003/C 178/02); médicaments orphelins; exclusivité commerciale de 10 ans; médicaments similaires; bénéfice notable; supériorité clinique;

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2015 سفارش ترجمه

Immunogenicity and safety of AS03A-adjuvanted H5N1 influenza vaccine prepared from bulk antigen after stockpiling for 4 years

Keywords: AEs; adverse events; CBER; US Center for Biologics Evaluation and Research; CHMP; Committee for Medicinal Products for Human Use; CIs; confidence intervals; GMTs; geometric mean titers; HA; hemagglutinin antigen; HI; hemagglutination-inhibition; MAEs; med

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2015 سفارش ترجمه

Immunogenicity and safety of an AS03-adjuvanted H5N1 pandemic influenza vaccine in Korean adults: A phase IV, randomized, open-label, controlled study

Keywords: AS03; H5N1 vaccine; Pandemic influenza; Korean adults; AEs; adverse events; CBER; US Center for Biologics Evaluation and Research; CHMP; Committee for Medicinal Products for Human Use; CI; confidence interval; EMA; European Medicines Agency; FDA; US Food

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2015 سفارش ترجمه

RTS,S: Toward a first landmark on the Malaria Vaccine Technology Roadmap

Keywords: CHMP; Committee for Medicinal Products for Human Use; CSP; circumsporozoite protein; EMA; European Medicines Agency; GFATM; Global Fund to Fight Aids, Tuberculosis and Malaria; HBsAg; hepatitis B virus surface antigen; ITT; intention-to-treat; JTEG; Joint

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2015 سفارش ترجمه

Superior immunogenicity profile of the new intradermal influenza vaccine compared to the standard subcutaneous vaccine in subjects 65 years and older: A randomized controlled phase III study

Keywords: ID; intradermal; SC; subcutaneous; HA; hemagglutinin; HAI; hemagglutination inhibition; GMT; geometrical mean titer; GMTR; ratio of GMT; SCR; seroconversion ratio; SPR; seroprotection ratio; AE; adverse event; CHMP; The Committee for Medicinal Products fo

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2015 سفارش ترجمه

Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects

Keywords: Influenza vaccine; MF59; Adjuvant; Non-inferiority; Superiority; Elderly; AE; adverse event; aTIV; adjuvanted trivalent influenza vaccine; CBER; Center for Biologics Evaluation and Research; CHMP; European Committee for Medicinal Products for Human Use; F

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2014 سفارش ترجمه

An observer-blind, randomized, multi-center trial assessing long-term safety and immunogenicity of AS03-adjuvanted or unadjuvanted H1N1/2009 influenza vaccines in children 10-17 years of age

Keywords: AEs; adverse events; CBER; Center for Biologics Evaluation & Research; CHMP; Committee for Medicinal Products for Human Use; CI; confidence interval; GMFR; geometric mean fold rise; GMT; geometric mean titer; HA; hemagglutinin; HI; hemagglutination inhibi

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2014 سفارش ترجمه

Elimination pathways of cyclosarin (GF) mediated by β-cyclodextrin in vitro: Pharmacokinetic and toxicokinetic aspects

Keywords: CD; cyclodextrin; β-CD; β-cyclodextrin; OP; organophosphorus compound(s); GF; cyclosarin; ESI/MS; electrospray ionization mass spectrometry; CHMPA; O-cyclohexylmethylphosphonic acid; CHMP; O-cyclohexylmethylphosphonate; TRIS; tris(hydroxymethyl)aminomet

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

Long-term immunogenicity of an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine in young and elderly adults: An observer-blind, randomized trial

Keywords: ATP; according to protocol; BARDA; Biomedical Advanced Research and Development Authority; BMI; body mass index; CBER; Center for Biologics Evaluation & Research; CHMP; Committee for Medicinal Products for Human Use; CI; confidence interval; GMFR; geometr

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

A randomised, single-blind, dose-range study to assess the immunogenicity and safety of a cell-culture-derived A/H1N1 influenza vaccine in adult and elderly populations

Keywords: MN; microneutralisation; HI; haemagglutination inhibition; CHMP; European Committee for Medicinal Products for Human Use; AE; adverse event; SAE; serious adverse event; GMR; geometric mean ratio; GMT; geometric mean titre; Influenza; H1N1; Pandemic; Adjuv

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

A randomized clinical trial to identify the optimal antigen and MF59® adjuvant dose of a monovalent A/H1N1 pandemic influenza vaccine in healthy adult and elderly subjects

Keywords: HI; haemagglutination inhibition; MN; microneutralization; CHMP; European committee for medicinal products for human use; AE; adverse event; SAE; serious adverse event; GMR; geometric mean ratio; GMT; geometric mean titre; ANOVA; analysis of variance; SD;

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: 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

Safety and immunogenicity of an AS03-adjuvanted A(H1N1)pmd09 vaccine administered simultaneously or sequentially with a seasonal trivalent vaccine in adults 61 years or older: Data from two multicentre randomised trials

Keywords: AE; adverse event; AS03; oil-in-water emulsion based adjuvant system; CHMP; Committee for Medicinal Products for Human Use; CI; confidence interval; GMFR; geometric mean fold rise; GMT; geometric mean titre; GSK; GlaxoSmithKline; HA; haemagglutinin antige

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

AMSH is required to degrade ubiquitinated proteins in the central nervous system

Keywords: AD; Alzheimer's disease; ALS; amyotrophic lateral sclerosis; AMSH; associated molecule with the SH3 domain of STAM; AMPAR; α-amino-3-hydroxy-5-methyl-isoxazolepropionic acid receptor; CHMP; chromatin modifying protein; ESCRT; endosomal sorting complexe

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: 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

Pregnancy and safety outcomes in women vaccinated with an AS03-adjuvanted split virion H1N1 (2009) pandemic influenza vaccine during pregnancy: A prospective cohort study

Keywords: AEs; adverse events; AESI; adverse events of special interest; AS03; oil-in-water emulsion-based Adjuvant System AS03; CDC; Centers for Disease Control and Prevention; CHMP; Committee for Medicinal Products for Human Use; EGA; estimated gestational age; G

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2011 سفارش ترجمه

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

Keywords: 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

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

Keywords: 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

Report of the 5th meeting on the evaluation of pandemic influenza prototype vaccines in clinical trials

Keywords: AEFI; adverse events following immunisation; AlPO4; aluminium phosphate; Al(OH)3; aluminium hydroxide; CHMP; Committee for Human Medicinal Products; ECBS; Expert Committee on Biological Standardisation; HAI; haemagglutination-inhibition; LAIV; live-attenu

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2009 سفارش ترجمه

If a drug deemed 'safe' in nonclinical tests subsequently prolongs QT in phase 1 studies, how can its sponsor convince regulators to allow development to proceed?

Keywords: CHMP; Committee for Medicinal Products for Human Use; COX; Cycloxygenase; ECG; Electrocardiogram; EU; European Union; FDA; Food and Drug Administration of the United States; hERG; Human ether-a-go-go related gene; ICH; International Conference on Harmoniz

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2008 سفارش ترجمه

A systematic analysis of human CHMP protein interactions: Additional MIT domain-containing proteins bind to multiple components of the human ESCRT III complex

Keywords: Protein interaction network; Multivesicular bodies; ESCRT III complex; MIT domain; CHMP; Yeast two-hybrid; Protein complementation assay

دانلود رایگان متن کامل مقاله ISI 14 صفحه سال انتشار : 2006 سفارش ترجمه