Glossaries
Glossaries
| Term | Definition |
|---|---|
| Nuremberg Code |
A code of ethics set forth in 1947 for the conduct of medical research, with the express purpose of protecting human medical research subjects.
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| null hypothesis |
The assertion that no true association or difference in the study outcome or comparison of interest between comparison groups exists in the larger population from which the study samples are obtained. NOTE: A null hypothesis (for example, "subjects will experience no change in blood pressure as a result of administration of the test product") is used to rule out every possibility except the one the researcher is trying to prove, and is used because most statistical methods are less able to prove something true than to provide strong evidence that it is false. The assertion that no true association or difference in the study outcome or comparison of interest between comparison groups exists in the larger population from which the study samples are obtained. See also research hypothesis. [from AMA Manual of Style]
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| Notified Body (NB) |
A private institution charged by the Competent Authority with verifying compliance of medical devices (not drugs) with the applicable Essential Requirements stated in the Medical Device Directive. This process, called Conformity Assessment, has EU-wide validity once completed by the NB.
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| not approvable letter |
An official communication from FDA to inform a sponsor of a marketing application that the important deficiencies described in the letter preclude approval unless corrected.
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| nonclinical study |
Biomedical studies not performed on human subjects. [ICH E6 (R2)]
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| non-interventional study |
A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorization. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data. [Clinical Trial Directive EC/20/2001 definitions]
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| non-inferiority (NI) trial |
A type of controlled trial to demonstrate that the new treatment is not less effective than the active control by a specified amount. [After Non-Inferiority Clinical Trials to Establish Effectiveness. FDA Guidance for Industry. November 2016]
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| non-confirmatory result |
In a trial, typically phase 3, results that fail to achieve statistical significance and therefore fail to confirm the preliminary evidence from other trials that a drug is safe and effective for use for the intended indication and population. NOTE: Non-confirmatory trial results provide useful scientific information. [After ICH E8] See also confirmatory trial.
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| nomenclature |
Application of naming conventions. Compare to vocabulary, terminology.
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| NOEL (no observable effect level) |
The dose of an experimental drug given preclinically that does not produce an observable toxicity.
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| new safety information |
Previously unknown safety information derived from: (A) a clinical trial, an adverse event report, a post-approval study, or peer-reviewed biomedical literature; (B) the post-market risk identification and analysis system (REMS); or, (C) other scientific data regarding, (i) a serious risk or unexpected serious risk associated with use of the drug since the drug was approved, since the REMS was required or last assessed, or (ii) the effectiveness of the approved REMS for the drug obtained since the last assessment of such strategy. [After 21 CFR, Part 505-1(b)]
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| New Drug Application (NDA) |
An application to FDA for a license to market a new drug in the United States.
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| NCI Enterprise Vocabulary Services (EVS) |
A US national resource to house and maintain a number of health-related glossaries and controlled vocabularies under strict versioning. Provides resources and services to meet the National Cancer Institute's needs for controlled terminology, and to facilitate the standardization of terminology and information systems across the NCI and the larger biomedical community.
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| natural language processing |
The use of algorithms to determine properties of natural, human language so that computers can understand what humans have written or said. NLP includes teaching computer systems how to extract data from bodies of written text, translate from one language to another, and recognize printed or handwritten words. NOTE: NLP is the field that allows for our everyday use of virtual assistants such as Siri, Alexa, or Google. [After DeepAI Definitions] See also artificial intelligence (AI).
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| natural language |
Language as used in ordinary communications among humans and distinguished from controlled terminologies and structured languages used exclusively for communication and interoperability among machines.
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