New drug and biological drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Final rule.
about
Broad spectrum antiviral activity of favipiravir (T-705): protection from highly lethal inhalational Rift Valley FeverRaxibacumabAnti-infective immunoadhesins from plants.Protecting against plague: towards a next-generation vaccineThe NIAID Integrated Research Facility at Frederick, Maryland: a unique international resource to facilitate medical countermeasure development for BSL-4 pathogensAntibodies for biodefenseRabbit and nonhuman primate models of toxin-targeting human anthrax vaccinesThe Evolving Mcart Multimodal Imaging Core: Establishing a Protocol for Computed Tomography and Echocardiography in the Rhesus Macaque to Perform Longitudinal Analysis of Radiation-Induced Organ Injury.Live attenuated mutants of Francisella tularensis protect rabbits against aerosol challenge with a virulent type A strain.Anthrax vaccine-induced antibodies provide cross-species prediction of survival to aerosol challengePractical advice on calculating confidence intervals for radioprotection effects and reducing animal numbers in radiation countermeasure experimentsExploring the potential of variola virus infection of cynomolgus macaques as a model for human smallpox.Filgrastim improves survival in lethally irradiated nonhuman primatesThe ability of filgrastim to mitigate mortality following LD50/60 total-body irradiation is administration time-dependent.AEOL 10150 Mitigates Radiation-Induced Lung Injury in the Nonhuman Primate: Morbidity and Mortality are Administration Schedule-Dependent.A characterization of aerosolized Sudan virus infection in African green monkeys, cynomolgus macaques, and rhesus macaquesComparison of three anthrax toxin neutralization assaysA monoclonal immunoglobulin G antibody directed against an immunodominant linear epitope on the ricin A chain confers systemic and mucosal immunity to ricin.A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE.Approaches to modelling the human immune response in transition of candidates from research to development.Activity of dalbavancin against Bacillus anthracis in vitro and in a mouse inhalation anthrax modelExperimental infection of cynomolgus macaques (Macaca fascicularis) with aerosolized monkeypox virus.Pneumonic tularemia in rabbits resembles the human disease as illustrated by radiographic and hematological changes after infectionProgression of pathogenic events in cynomolgus macaques infected with variola virusEfficacy of Daptomycin against Bacillus anthracis in a murine model of anthrax spore inhalation.Smallpox vaccine with integrated IL-15 demonstrates enhanced in vivo viral clearance in immunodeficient mice and confers long term protection against a lethal monkeypox challenge in cynomolgus monkeys.Statistical analysis of survival data from radiation countermeasure experiments.Combination therapy with antibiotics and anthrax immune globulin intravenous (AIGIV) is potentially more effective than antibiotics alone in rabbit model of inhalational anthrax.Effective antimicrobial regimens for use in humans for therapy of Bacillus anthracis infections and postexposure prophylaxis.Identification of process related trace level impurities in the actinide decorporation agent 3,4,3-LI(1,2-HOPO): Nozzle-skimmer fragmentation via ESI LC-QTOFMS.The impact of "omic" and imaging technologies on assessing the host immune response to biodefence agents.Severe acute respiratory syndrome coronavirus infection of golden Syrian hamsters.TNFα and IFNγ contribute to F1/LcrV-targeted immune defense in mouse models of fully virulent pneumonic plague.Animal models for medical countermeasures to radiation exposure.Animal models of tick-borne hemorrhagic Fever viruses.Determination of sample sizes for demonstrating efficacy of radiation countermeasures.Determination of antibiotic efficacy against Bacillus anthracis in a mouse aerosol challenge model.Efficacy of CMX001 as a prophylactic and presymptomatic antiviral agent in New Zealand white rabbits infected with rabbitpox virus, a model for orthopoxvirus infections of humansDevelopment of CMX001 for the Treatment of Poxvirus Infections.Captopril and losartan for mitigation of renal injury caused by single-dose total-body irradiation.
P2860
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P2860
New drug and biological drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Final rule.
description
2002 nî lūn-bûn
@nan
2002年の論文
@ja
2002年学术文章
@wuu
2002年学术文章
@zh
2002年学术文章
@zh-cn
2002年学术文章
@zh-hans
2002年学术文章
@zh-my
2002年学术文章
@zh-sg
2002年學術文章
@yue
2002年學術文章
@zh-hant
name
New drug and biological drug p ...... hical or feasible. Final rule.
@en
New drug and biological drug p ...... hical or feasible. Final rule.
@nl
type
label
New drug and biological drug p ...... hical or feasible. Final rule.
@en
New drug and biological drug p ...... hical or feasible. Final rule.
@nl
prefLabel
New drug and biological drug p ...... hical or feasible. Final rule.
@en
New drug and biological drug p ...... hical or feasible. Final rule.
@nl
P1433
P1476
New drug and biological drug p ...... hical or feasible. Final rule.
@en
P304
37988-37998
P577
2002-05-01T00:00:00Z