drug development tool
- Guideline or reference source
- FDAPNG Patient network glossary terms
- Definition
- A DDT is a method (and associated materials) that aids drug development. DDTs include, but are not limited to, biomarkers, clinical trial outcome assessments, and animal models. DDTs suitable for the CDER DDT Qualification process are a subset of all types of DDTs, and should be intended for potential use, over time, in multiple drug development programs. Some DDTs used as clinical trial outcome assessments may sometimes be called an instrument. The term “instrument”, or “tool”, refers to the means to capture data plus all the information and documentation that support its use within the intended context of use.
- Abbreviation for
- DDT
- Related Term
- biomarker
- clinical outcome assessment
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