9 Terms
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Clinical trials
Clinical trials are sets of tests performed for medical research and drug development which is used to extract safety and efficacy data.
Industry: Medical devices; Pharmaceutical
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Clinical trials
Efficacy
Pharmaceutical; Clinical trials
(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the ...
Eligibility criteria
Pharmaceutical; Clinical trials
Summary criteria for participant selection; includes Inclusion and Exclusion criteria.
Enrolling
Pharmaceutical; Clinical trials
The act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent ...
Expanded access
Pharmaceutical; Clinical trials
Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently available treatments ...
Experimental drug
Pharmaceutical; Clinical trials
A drug that is not FDA licenced for use in humans, or as a treatment for a particular condition
Food and Drug Administration
Pharmaceutical; Clinical trials
The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the ...
