دانلود مقالات ISI درباره Cber + ترجمه فارسی

وضعیت مورد نیاز آزمایشات سمیت سیستمیک و داده ها توسط سازمان های نظارتی ایالات متحده مورد استفاده قرار می گیرد

Status of acute systemic toxicity testing requirements and data uses by U.S. regulatory agencies

Keywords: Acute systemic toxicity; Alternative approaches; Non-animal methods; Regulatory requirements; LD50; LC50; In vitro; In silico; AEGL; Acute Exposure Guideline Level; CBER; FDA Center for Biologics Evaluation and Research; CDER; FDA Center for Drug Evaluati

دانلود رایگان متن کامل مقاله ISI 14 صفحه سال انتشار : 2018 سفارش ترجمه

گزارش کنفرانس بین المللی توالی نسل بعدی برای تشخیص ویروس های احتمالی در زیست شناسی

Report of the international conference on next generation sequencing for adventitious virus detection in biologicals

Keywords: Adventitious viruses; Biologics; Vaccines; Biotherapeutics; Cell substrate; Next generation sequencing; High throughput sequencing; Bioinformatics; NGS; next-generation sequencing; HTS; high-throughput sequencing; FDA; U.S. Food and Drug Administration; C

دانلود رایگان متن کامل مقاله ISI 16 صفحه سال انتشار : 2018 سفارش ترجمه

سیستم ارزیابی و ارزیابی کیفیت تشخیص اچ آی وی در چین

Regulation and quality evaluation system for HIV diagnostics in China

Keywords: Regulatory framework; Quality evaluation system; National reference panel; HIV diagnostics; China; HIV; Human immunodeficiency virus; AIDS; Acquired Immuno-Deficiency Syndrome; NAT; nucleic acid tests; ELISA; enzyme-linked immunosorbent assay; NIFDC; Nati

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

ملاحظات مربوط به گرده مورد استفاده برای تولید عصاره آلرژن

Considerations About Pollen Used for the Production of Allergen Extracts

Keywords: Pollen raw materials; Allergen extracts; Allergen extracts manufacturers; Pollen collection; Regulations; CBER; Center for Biologics Evaluations and Research; FDA; Food and Drug Administration;

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

15th Annual Meeting of the Safety Pharmacology Society: Focus on traditional sensory systems

Keywords: α2M; alpha2-macroglobuline; ARMD; age-related macular degeneration; AMP; adenosine monophosphate; ATP; adenosine triphosphate; ASR; acoustic startle response; BM; basilar membrane; cAMP; cyclic adenosine monophosphate; CBER; Center for Biologics Evaluati

دانلود رایگان متن کامل مقاله ISI 17 صفحه سال انتشار : 2017 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

Developing aerosol vaccines for Mycobacterium tuberculosis: Workshop proceedings

Keywords: AM; arabinomannan; BAL; bronchoalveolar lavage; BCG; Bacille Calmette-Guérin; CFU; colony-forming units; CBER; center for biologics evaluation and research; CDRH; center for devices and radiological health; CMs; cynomolgus macaques; DPI; dry powder inhal

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

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

Immunological priming induced by a two-dose series of H5N1 influenza antigen, administered alone or in combination with two different formulations of AS03 adjuvant in adults: Results of a randomised single heterologous booster dose study at 15 months

Keywords: AE; adverse event; ANCOVA; analysis of covariance; AS03; oil-in-water emulsion based Adjuvant System containing tocopherol; ATP; according to protocol; CBER; Center for Biologics Evaluation and Research; CI; confidence interval; FDA; Food and Drug Adminis

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

The catalytic binuclear elimination reaction: Confirmation from in situ FTIR studies of homogeneous rhodium catalyzed hydroformylation

Keywords: In situ FTIR; BTEM; Hydroformylation; CBER; Rhodium; Synergism

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2010 سفارش ترجمه