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Resource Summary Report New Search

Resource Name

Drug Development Tools Qualification Programs

RRID:SCR_003714 RRID Copied

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Drug Development Tools Qualification Programs (RRID:SCR_003714)

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Resource Information

URL: http://www.fda.gov/drugs/developmentapprovalprocess/drugdevelopmenttoolsqualificationprogram/default.htm

Proper Citation: Drug Development Tools Qualification Programs (RRID:SCR_003714)

Description: To support Drug Development Tools development efforts, FDA established qualification programs for animal models for use under Animal Rule, biomarkers, and clinical outcome assessments. DDTs are methods, materials, or measures that have potential to facilitate drug development. Examples of DDTs may include, but are not limited to biomarker2 used for clinical trial enrichment, clinical outcome assessment used to evaluate clinical benefit, and animal model used for efficacy testing of medical countermeasures under regulations commonly referred to as Animal Rule3.

Abbreviations: DDT Qualification Programs

Synonyms: Drug Development Tools (DDT) Qualification Programs

Resource Type: data or information resource, portal

Keywords: Drug1 Development Tools, FDA established qualification programs, animal models for use under Animal Rule, gold standard

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Funding:

Availability: Public

Resource Name: Drug Development Tools Qualification Programs

Resource ID: SCR_003714

Alternate IDs: nlx_157888

Record Creation Time: 2022-01-29 12:02:20

Record Last Update: 2025-04-07 02:54:00

This resource

has parent organization	U.S. Food and Drug Administration
is parent organization of	PSTC Nephrotoxicity Biomarkers
is parent organization of	ILSI HESI Drug-induced Nephrotoxicity Biomarkers
is parent organization of	O'Brien Reagan York and Jacobsen Drug-induced Cardiotoxicity Biomarkers
is parent organization of	Exacerbations of Chronic Pulmonary Disease Tool

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