Questions and Answers
What is an investigational drug?
Where are the major centers for clinical studies with investigational drugs?
What is another term used for investigational drugs?
Under whose supervision should investigational drugs be used?
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Which regulatory body has not yet approved investigational drugs for general use?
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What must a principal investigator secure before using investigational drugs?
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What defines the range of doses for investigational drugs?
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What obligation do hospitals have towards patients regarding the use of investigational drugs?
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Which of the following is true about investigational drugs?
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For what purpose are investigational drugs being studied?
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Study Notes
Investigational Use of Drugs
- An investigational drug is a drug or placebo being tested in a clinical trial, including a registered drug used:
- In a different formulation
- For an unapproved indication
- In doses outside the approved range
- These drugs are also called experimental drugs and are being studied to see if a disease or medical condition improves while taking them
Principles
Clinical Investigations in Hospitals
- Hospitals are the primary centers for clinical investigations on investigational drugs
- Investigational drugs have not yet been released by the Federal Food and Drug Administration for general use
- They have not been certified for general use and have not been cleared for sale in interstate commerce by the Federal Food and Drug Administration
Control of Investigational Drugs
- Procedures for the control of investigational drugs should be based on the following principles:
- Investigational drugs should be used only under the direct supervision of the principal investigator
- The principal investigator should be a member of the medical staff and assume the burden of securing the necessary consent
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Description
This quiz covers the concept of investigational drugs, also known as experimental drugs, which are being tested in clinical trials to see if they improve diseases or medical conditions. Learn about their uses, formulations, and indications.
