Preclinical Services for HIV Therapeutics: QA/QC Plan and Task Order Initiation Meeting
Preclinical Services for HIV Therapeutics: QA/QC Plan and Task Order Initiation Meeting
批准号:
10397447
负责人:
JACOB MCDONALD
金额:
$1.89万
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
已结题
起止时间:
2021-04-15 至 2021-08-14
关键词:
Acquired Immunodeficiency SyndromeAreaBasic ScienceClinical TrialsCollaborationsCommunitiesComplexContractsDevelopmentDevicesExtramural ActivitiesHIVHepatitis B VirusHepatitis C virusInvestigationInvestigational New Drug ApplicationInvestigator-Initiated ResearchLicensureMycobacterium tuberculosisNational Institute of Allergy and Infectious DiseasePharmacology and ToxicologyPrivate SectorQuality ControlResearchResourcesServicesTherapeuticUnited States Food and Drug AdministrationWorkmeetingsnovel therapeuticspre-clinicalproduct developmentquality assurancerepositoryresearch clinical testingresearch studytherapeutic development
中文摘要
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英文摘要
Preclinical Services for HIV Therapeutics: The purpose of these Indefinite Delivery/Indefinite Quantity contracts is to provide the extramural scientific community with research materials and preclinical product development support for candidate products that emerge from investigator-initiated research studies or from collaborations with private sector or academic partners. The scope of work encompasses activities that range from basic research and initial product discovery to activities required for clinical trials and/or product licensure. These services may also be used to support product discovery and development leading to Investigational New Drug Application (IND), Investigational Device Exemption (IDE), and/or New Drug Application (NDA) filings with the Food and Drug Administration (FDA). NIAID Division of AIDS will primarily use these contracts to fill critical development and resource gaps more rapidly and efficiently and advance promising products into clinical testing. The focus of these contracts will be development of therapeutic products for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Mycobacterium tuberculosis (MTB) complex, as well as repository services.
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