Investigational Use of Drugs
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Questions and Answers

What is an investigational drug?

  • A drug approved by the FDA for general use
  • Any drug or placebo being tested in a clinical trial (correct)
  • A drug used only for a non-medical purpose
  • A registered drug under normal use

Where are the major centers for clinical studies with investigational drugs?

  • Community centers
  • Research laboratories
  • Hospitals and other healthcare agencies (correct)
  • Pharmacies

What is another term used for investigational drugs?

  • Approved drugs
  • Generic drugs
  • Traditional drugs
  • Experimental drugs (correct)

Under whose supervision should investigational drugs be used?

<p>The principal investigator (C)</p> Signup and view all the answers

Which regulatory body has not yet approved investigational drugs for general use?

<p>Federal Food and Drug Administration (B)</p> Signup and view all the answers

What must a principal investigator secure before using investigational drugs?

<p>Necessary consent (B)</p> Signup and view all the answers

What defines the range of doses for investigational drugs?

<p>FDA approved range (B)</p> Signup and view all the answers

What obligation do hospitals have towards patients regarding the use of investigational drugs?

<p>Ensuring proper usage procedures (B)</p> Signup and view all the answers

Which of the following is true about investigational drugs?

<p>They are used under specific investigational conditions (D)</p> Signup and view all the answers

For what purpose are investigational drugs being studied?

<p>To determine if they improve a disease or medical condition (C)</p> Signup and view all the answers

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.

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