Category: D

Dropout

A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the

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Dose-Ranging Study

A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose

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Dose

The amount of medicine taken, or radiation given, at one time. Source: NCI

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Drug Product (DP)

[A] finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other

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Dosage Strength

(1) The proportion of active drug substance to excipient, measured in units of volume or concentration.(2) The strength of a drug product, which indicates the

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Dosage Form

The physical state in which a drug is dispensed for use. For example: a frequent dosage form of procaine is a sterile solution of procaine.

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Digital Signature

An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the

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Device

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended

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Define.xml

“Define-XML is a file tha metadata that describes any tabular dataset structure. When used with the CDISC Foundational Standards, it provides the metadata for human

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Data Listings

“Data listings are datasets in which each record is a series of observations collected foreach subject during a study or for each subject for each

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DailyMed

DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional products such as medical gases, devices, cosmetics, dietary supplements,

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Drug Substance (DS)

[FDA] [An] active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease

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