BIOLOGICAL TESTING FACILITY
BIOLOGICAL TESTING FACILITY
批准号:
8937275
负责人:
KAREN STEINMETZ
金额:
$65.0万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2012
资助国家:
美国
项目状态:
已结题
起止时间:
2012-09-28 至 2015-09-28
关键词:
AndrogensAnimal TestingAnimalsApidaeApisBiologicalBiological TestingCastor OilClinicalClinical TrialsContraceptive AgentsDevelopmentDevicesDocumentationDosage FormsDrug FormulationsEndocrineEvaluationFertilityHumanInvestigationNandroloneParticle SizePharmaceutical PreparationsPlacebosPowder dose formPreparationQuality ControlRegulationRouteSafetyServicesShippingShipsSystemTestingValidationWorkanalytical methodcapsuledesignhuman subjectimprovedpre-clinicalstability testinguptake
中文摘要
生物测试设施的设计允许快速评估新的物质成分,
用于抗生育或避孕和内分泌活动的药物配方、给药系统和装置。
该任务将支持背景中描述的临床前活动。更进一步,动物
支持、临床配方、临床批次制剂和释放、安全稳定服务
必须提供可在CCTN中评估的GMP原料药,包括所有文档
根据申请,将在临床试验中支持批量释放和测试的IND将是
由这项任务支持。
英文摘要
Biological Testing Facility is designed to permit rapid evaluation of new compositions of matter,
drug formulations, delivery systems, and devices for anti-fertility or contraceptive and endocrine activity.
The task will support preclinical activities as described in the background. Further, animal
support, clinical formulation, clinical batch preparation and release, safety and stability services
necessary to provide GMP APis that can be evaluated in the CCTN, including all documentation
pursuant to filing an IND that would support batch release and testing in clinical trials will be
supported by this task.
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专著(0)
科研奖励(0)
会议论文
BIOLOGICAL TESTING FACILITY - DMAU CLINICAL SUPPLIES AND STABILITY TESTING OF DMAU CAPSULES
-
批准号:8937289
-
项目类别:
-
资助金额:$100.4万
-
财政年份:2012
-
负责人:KAREN STEINMETZ
-
依托单位:
Alcohol and Epidemiological Data System (AEDS)
-
批准号:8328311
-
项目类别:
-
资助金额:$0.87万
-
财政年份:2010
-
负责人:KAREN STEINMETZ
-
依托单位:
^Investigational New Drug Toxicology for Drugs to Treat AD & Other Aging-Related
-
批准号:8338716
-
项目类别:
-
资助金额:$16.41万
-
财政年份:2010
-
负责人:KAREN STEINMETZ
-
依托单位:
BIOLOGICAL TESTING FACILITY FOR CRH
-
批准号:7947217
-
项目类别:
-
资助金额:$305.38万
-
财政年份:2009
-
负责人:KAREN STEINMETZ
-
依托单位:
PHARMACOKINETIC AND PHARMACODYNAMIC STUDIES FOR MEDICATIONS DEVELOPMENT
-
批准号:8335334
-
项目类别:
-
资助金额:$38.4万
-
财政年份:2006
-
负责人:KAREN STEINMETZ
-
依托单位:
Modeling Immunity for Biodefense
-
批准号:8335364
-
项目类别:
-
资助金额:$4.0万
-
财政年份:2005
-
负责人:KAREN STEINMETZ
-
依托单位:
Task D21: Evaluation of Orthopox Vaccination
-
批准号:8328365
-
项目类别:
-
资助金额:$41.45万
-
财政年份:2004
-
负责人:KAREN STEINMETZ
-
依托单位:
INVESTIGATIONAL NEW DRUG TOXICOLOGY FOR DRUGS TO TREAT ALZHEIMER'S DISEASE AND O
-
批准号:7543825
-
项目类别:
-
资助金额:$129.25万
-
财政年份:2004
-
负责人:KAREN STEINMETZ
-
依托单位:--
Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial
-
批准号:8335323
-
项目类别:
-
资助金额:$27.77万
-
财政年份:1992
-
负责人:KAREN STEINMETZ
-
依托单位:
Investigational New Drug Toxicology for Drugs to Treat Alzheimer's Disease and Ot
-
批准号:8340929
-
项目类别:
-
资助金额:$23.84万
-
财政年份:--
-
负责人:KAREN STEINMETZ
-
依托单位:
Investigational New Drug Toxicology for Drugs to Treat Alzheimer's Disease and Ot
-
批准号:8340932
-
项目类别:
-
资助金额:$14.48万
-
财政年份:--
-
负责人:KAREN STEINMETZ
-
依托单位:
Investigational New Drug Toxicology for Drugs to Treat Alzheimer's Disease and Ot
-
批准号:8340930
-
项目类别:
-
资助金额:$39.32万
-
财政年份:--
-
负责人:KAREN STEINMETZ
-
依托单位:
Investigational New Drug Toxicology for Drugs to Treat Alzheimer's Disease and Ot
-
批准号:8340931
-
项目类别:
-
资助金额:$15.29万
-
财政年份:--
-
负责人:KAREN STEINMETZ
-
依托单位:
海外基金