Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health EmergencyOriginal Research Published on 2024-06-242024-09-05 Journal: Therapeutic innovation & regulatory science [Category] update2024, [키워드] clinical trials COVID-19 Drug development qualitative research United States Food and Drug Administration [DOI] 10.1007/s43441-024-00674-x PMC 바로가기 [Article Type] Original Research
Presumptive positive with the Cepheid Xpert Xpress SARS-CoV-2 assay due to N mutations in the Delta variantDelta 변이체의 N 돌연변이로 인한 Cepheid Xpert Xpress SARS-CoV-2 분석에서 추정 양성Article Published on 2022-07-012022-09-11 Journal: Diagnostic microbiology and infectious disease [Category] COVID19(2023년), SARS, 변종, 치료기술, 치료제, [키워드] 2019-nCoV authorization C29200T C29203T Cepheid Cepheid Xpert® Xpress SARS-CoV-2 assay Chain Reaction Delta delta variant Delta variants drug Emergency Emergency use authorization false False negative FDA food indicated Mutation N gene N mutation PCR assay platform Point mutation point mutations polymerase chain polymerase chain reaction positive presumptive positive. real time PCR real-time RT-PCR reported reverse transcription RT-PCR RT-PCR assay SARS-CoV-2 SARS-CoV-2 detection the United State United States United States Food and Drug Administration US CDC variants Whole genome sequencing [DOI] 10.1016/j.diagmicrobio.2022.115699 PMC 바로가기 [Article Type] Article
Quantitative analysis of favipiravir and hydroxychloroquine as FDA-approved drugs for treatment of COVID-19 using synchronous spectrofluorimetry: application to pharmaceutical formulations and biological fluids동시 분광형광법을 사용한 COVID-19 치료를 위한 FDA 승인 약물인 favipiravir 및 hydroxychloroquine의 정량 분석: 제약 제제 및 생물학적 유체에 적용Article Published on 2022-06-012022-09-11 Journal: Luminescence : the journal of biological and chemi [Category] COVID19(2023년), SARS, 치료기술, [키워드] Acetate acute respiratory syndrome Analysis applied approach biological fluid biological fluids buffer cause caused condition contagious coronavirus coronavirus 2 coronavirus disease Coronavirus disease 2019 country COVID-19 Detection limit diluent drug Drug administration Ethanol exhibited Favipiravir FDA-approved drug fluorescence intensity food harmonization Healthcare systems human plasma sample human plasma samples Hydroxychloroquine identify information Interference International Conference investigated limit limits medications Pharmaceutical Preparation pharmaceutical preparations quantitation SARS-CoV-2 sensitivity Severe acute respiratory syndrome synchronous synchronous fluorimetry. Treatment United State United States United States Food and Drug Administration viral infection were measured [DOI] 10.1002/bio.4240 PMC 바로가기 [Article Type] Article
Remdesivir Metabolite GS-441524 Effectively Inhibits SARS-CoV-2 Infection in Mouse ModelsRemdesivir 대사 산물 GS-441524, 마우스 모델에서 SARS-CoV-2 감염을 효과적으로 억제Article Published on 2022-02-242022-09-11 Journal: Journal of medicinal chemistry [Category] MERS, 진단, 치료제, [키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 approved cell lines challenge conducted coronavirus coronavirus disease Coronavirus disease 2019 CoV COVID-19 Diseases drug drug candidate Effectiveness food global pandemic GS-441524 Health Organization Hepatitis infected organs inhibit manuscript mice Model mouse murine hepatitis virus notable nucleoside organ outbreak parent nucleoside question reducing Remdesivir Replication replication of SARS-CoV-2 respiratory SARS-CoV-2 severe acute respiratory syndrome Coronavirus Solidarity trial Spread Support the United State Toxicity treating Treatment United States United States Food and Drug Administration Vero E6 Viral viral titer viral titers World Health Organization [DOI] 10.1021/acs.jmedchem.0c01929 PMC 바로가기 [Article Type] Article
The Efficacy of Convalescent Plasma Use in Critically Ill COVID-19 Patients중환자 COVID-19 환자에서 회복기 혈장 사용의 효능Article Published on 2021-03-112022-09-10 Journal: Medicina [Category] SARS, 치료제, [키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 administration approval Blood cells C-reactive protein convalescent plasma Convalescent plasma therapy coronavirus coronavirus disease Coronavirus disease 2019 Course COVID-19 COVID-19 patients Critically ill critically ill COVID-19 patients Critically ill patient critically ill patients determine diagnosed diagnosed with COVID-19 drug Efficacy effort eligibility eligible patient Evidence Evolution FDA FIVE food Ill interleukin interleukin-6 Laboratory material over Patient pilot study provide recovered completely respiratory Romania SARS CoV-2 SARS-CoV-2 SARS-COV-2 infection selected severe acute respiratory syndrome Coronavirus significantly lower surviving patient surviving patients the United State therapeutic option transfusion Treatment United States United States Food and Drug Administration White blood cells [DOI] 10.3390/medicina57030257 PMC 바로가기 [Article Type] Article
MicroRNAs and SARS-CoV-2 life cycle, pathogenesis, and mutations: biomarkers or therapeutic agents?MicroRNA와 SARS-CoV-2 수명 주기, 병인 및 돌연변이: 바이오마커 또는 치료제?Review Published on 2021-01-012022-09-11 Journal: Cell cycle (Georgetown, Tex.) [Category] MERS, SARS, 바이오마커, 변종, 치료제, [키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Antiviral antiviral agent antiviral drug antiviral drugs applied binding Biomarker candidate cell proliferation complementary coronavirus coronavirus disease Coronavirus disease 2019 coronavirus vaccine COVID-19 COVID-19 therapy database databases determine differentiation drug Drug administration Efficacy Emergency use authorization food genomic genomic mutations Google Scholar involved life cycle metabolism microRNA miRNA miRNAs mRNA degradation mutations Pathogenesis pathological conditions pathophysiology patients patogenecity physiological protein synthesis respiratory RNAs SARS-CoV-2 SARS-CoV-2 life cycle searched severe acute respiratory syndrome Coronavirus shown single-stranded Stage target mRNA the SARS-CoV-2 the United State therapeutic therapy United States United States Food and Drug Administration untranslated region UTR Vaccine virus Web of Science [DOI] 10.1080/15384101.2020.1867792 PMC 바로가기 [Article Type] Review