Authorization of the first COVID-19 emergency vaccines: The matters arisingLetter to the Editor Published on 2021-03-152022-10-31 Journal: EXCLI Journal [Category] COVID-19, [키워드] arising authorization COVID-19 emergency [DOI] 10.17179/excli2021-3384 PMC 바로가기 [Article Type] Letter to the Editor
SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacitySalivaDirect: SARS-CoV-2 테스트 용량을 향상시키는 간소화되고 유연한 플랫폼Article Published on 2021-03-122022-09-11 Journal: Med (New York, N.Y.) [Category] MERS, SARS, 진단, 치료기술, [키워드] authorization center Cohort COVID-19 diagnostic diagnostic test drug Emergency Emergency use authorization ENhance EUA false False-positive family FDA flexible food George Mason global health healthy individual healthy individuals hospital Laboratory Large-scale testing molecular molecular testing Nasopharyngeal swab nasopharyngeal swabs nucleic acid nucleic acid extraction partnership platform Population screening positive qRT-PCR qRT-PCR assay reagent reagents replacing RUBICON Safe Saliva saliva specimen saliva specimens SARS-CoV-2 SARS-CoV-2 testing Scaling specimen supply Supply chain supported Swab swabs tested U.S. Food and Drug Administration university [DOI] 10.1016/j.medj.2020.12.010 PMC 바로가기 [Article Type] Article
COVID-19 vaccines: rapid development, implications, challenges and future prospectsCOVID-19 백신: 빠른 개발, 의미, 도전 및 미래 전망Review Published on 2021-03-072022-08-31 Journal: Human Cell [Category] 신약개발, [키워드] accelerated addition affected America approved authorization Canada China clinical development complications COVID-19 COVID-19 pandemic COVID-19 vaccine COVID-19 vaccine development COVID-19 vaccines Distributing Emergency Emergency use authorization EUA example Government Healthcare system Healthcare systems Implications include India mitigate pandemic raised Russia Safe SARS-CoV-2 South Africa Spread strain the vaccine therapy for COVID-19 United Kingdom United State United States USA vaccination Vaccine vaccine candidates vaccine developers Vaccine development Vaccine hesitancy Vaccines [DOI] 10.1007/s13577-021-00512-4 PMC 바로가기 [Article Type] Review
First COVID-19 Vaccines Receiving the US FDA and EMA Emergency Use AuthorizationFocused Review Published on 2021-03-052022-11-01 Journal: Discoveries [Category] COVID-19, [키워드] authorization Commission Contact contagiousness coronavirus COVID-19 COVID-19 associated symptom Critical EMA Emergency Emergency use authorization Europe European Medicines Agency. globe Government incidence increase in individuals Infection limitations Moderna mRNA vaccine mRNA-based vaccines pandemic Pneumonia reported resource responsible restrict Spread Stage the disease the vaccine Treatment triggered US FDA US Food and Drug Administration USA Vaccine Vaccine development virus Wuhan [DOI] 10.15190/d.2021.1 PMC 바로가기 [Article Type] Focused Review
Emergency Use Authorization for Remdesivir and Its Potential Implications렘데시비르의 긴급 사용 승인 및 잠재적 영향Article Published on 2021-03-012022-09-11 Journal: Therapeutic innovation & regulatory science [Category] SARS, 치료제, [키워드] authorization Emergency Potential [DOI] 10.1007/s43441-020-00212-5 PMC 바로가기 [Article Type] Article
Remdesivir: Critical Clinical Appraisal for COVID 19 Treatment렘데시비르: COVID 19 치료에 대한 중요한 임상 평가Review Published on 2021-03-012022-09-11 Journal: Drug research [Category] SARS, 신약개발, 유전자 메커니즘, 임상, 치료제, [키워드] appraisal approved authorization clinical Clinical research Clinical studies clinical trial conducted COVID 19 COVID19 effective Emergency Hope In-vitro information mechanism MERS molecule Regulatory Remdesivir Research therapeutic molecules Usage virus [DOI] 10.1055/a-1288-4078 PMC 바로가기 [Article Type] Review
Combination of Hydroxychloroquine Plus Azithromycin As Potential Treatment for COVID-19 Patients: Safety Profile, Drug Interactions, and Management of ToxicityCOVID-19 환자를 위한 잠재적 치료제로서 하이드록시클로로퀸과 아지트로마이신의 조합: 안전성 프로파일, 약물 상호작용 및 독성 관리Review Published on 2021-03-012022-09-10 Journal: Microbial Drug Resistance [Category] SARS, 치료제, [키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 authorization Azithromycin caused clinical trial clinician Combination contagious contagious disease contributing to coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 patient COVID-19 patients disease drug Drug–drug interactions early treatment effective Efficacy Evidence Hydroxychloroquine identify Infection information Potential Prevent profile rationale reported respiratory Safe Safety severe acute respiratory syndrome Coronavirus severe acute respiratory syndrome coronavirus 2 therapeutic strategy Toxicity treat Treatment [DOI] 10.1089/mdr.2020.0232 PMC 바로가기 [Article Type] Review
US FDA erratic approach to placebo-controlled trials after issuing an emergency use authorization for a COVID-19 vaccineCOVID-19 백신에 대한 긴급 사용 승인을 발행한 후 위약 대조 시험에 대한 미국 FDA의 엉뚱한 접근Article Published on 2021-02-222022-08-31 Journal: Vaccine [Category] MERS, 신약개발, 임상, [키워드] Abstract approach authorization candidate Candidate vaccines clinical clinical trials COVID-19 COVID-19 vaccine Emergency Emergency use authorization Expanded access FDA phase Phase 3 trials placebo-controlled trial SARS-CoV-2 US FDA [DOI] 10.1016/j.vaccine.2021.01.050 PMC 바로가기 [Article Type] Article
Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemicCOVID-19 전염병 동안 접근 프로그램 확대, 동정적 약물 사용 및 긴급 사용 승인Review Published on 2021-02-012022-09-11 Journal: Drug discovery today [Category] MERS, SARS, 신약개발, 진단, 치료제, [키워드] access approval approved authorization bamlanivimab Baricitinib Casirivimab clinical trials compassionate use convalescent plasma coronavirus COVID-19 COVID-19 pandemic description diagnostics drug Effectiveness Emergency EUA Expanded access Experimental drugs FDA focus food Hydroxychloroquine Imdevimab Infectious disease pandemic pharmacological Program propofol Remdesivir ruxolitinib Threats US Food and Drug Administration Vaccine while [DOI] 10.1016/j.drudis.2020.11.025 PMC 바로가기 [Article Type] Review
Messengers of hope희망의 메신저Editorial Published on 2021-01-012022-09-11 Journal: Nature biotechnology [Category] 신약개발, [키워드] authorization Emergency messenger mRNA COVID-19 vaccine pandemic [DOI] 10.1038/s41587-020-00807-1 PMC 바로가기 [Article Type] Editorial