Pharmacology: Drug Development and Safety
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Questions and Answers

What is the primary purpose of preclinical research in drug development?

  • To compare the drug with similar drugs on the market
  • To determine the optimal dosage of the drug
  • To identify potential toxicity and side effects of the drug (correct)
  • To test the effectiveness of the drug in humans

What is one way researchers discover new drugs?

  • By reviewing medical literature and publications
  • By conducting surveys of medical professionals
  • Through clinical trials with human subjects
  • By testing existing treatments for unanticipated effects (correct)

What do researchers investigate during the development stage of drug development?

  • The best marketing strategy for the drug
  • The potential interactions with other drugs and treatments (correct)
  • The optimal pricing for the drug
  • The most effective way to patent the drug

What is the primary focus of the FDA post-market drug safety monitoring?

<p>To identify rare side effects not detected during clinical trials (B)</p> Signup and view all the answers

What is one way to improve the discovery of new drugs?

<p>By using new technologies to target medical products (D)</p> Signup and view all the answers

What is the primary purpose of the FDA drug review process?

<p>To ensure the drug is safe and effective for use in humans (C)</p> Signup and view all the answers

What do researchers investigate during preclinical research?

<p>The potential benefits and toxicity of the drug (C)</p> Signup and view all the answers

Why might a drug be withdrawn from the market or recalled?

<p>Due to serious side effects or toxicity (C)</p> Signup and view all the answers

What is the primary concern in human trials?

<p>Informed consent of participants (D)</p> Signup and view all the answers

What must be included in an Investigational New Drug (IND) application?

<p>All of the above, plus data from prior human research and investigator information (C)</p> Signup and view all the answers

What is drug recall?

<p>A process for withdrawing or removing a pharmaceutical product from the market (A)</p> Signup and view all the answers

Why was the Ranitidine Tablets recalled?

<p>NDMA impurity (D)</p> Signup and view all the answers

What should consumers do if they have Ranitidine Tablets subject to recall?

<p>Discontinue use and consult with their physician or healthcare provider (D)</p> Signup and view all the answers

Who can initiate a drug recall?

<p>The manufacturer, wholesale dealer, or Department of Health (C)</p> Signup and view all the answers

What is the purpose of informed consent?

<p>To provide information about clinical trial aims and risks (C)</p> Signup and view all the answers

What is the primary purpose of subacute toxicity studies?

<p>To examine the effects of a drug on overt toxicity, food intake, and body weight (C)</p> Signup and view all the answers

What is a common reason for drug recall?

<p>All of the above, plus correct product but wrong strength (C)</p> Signup and view all the answers

What is the duration of chronic toxicity studies?

<p>6-12 months (A)</p> Signup and view all the answers

What is the primary purpose of reproduction and teratogenicity studies?

<p>To evaluate the effects of a drug on fertility and developing foetus (B)</p> Signup and view all the answers

What is the purpose of the Ames test?

<p>To evaluate the mutagenicity of a drug (C)</p> Signup and view all the answers

What is the primary purpose of clinical trials?

<p>To evaluate the safety and efficacy of a drug in humans (C)</p> Signup and view all the answers

What is the purpose of a protocol in clinical trials?

<p>To outline the study plan and guide the trial (B)</p> Signup and view all the answers

What is the primary purpose of guidelines in clinical trials?

<p>To protect participants in clinical trials (C)</p> Signup and view all the answers

What is the purpose of reviewing prior information about a drug before designing a clinical trial?

<p>To develop research questions and objectives (B)</p> Signup and view all the answers

What type of test is used to detect specific activity, such as vasodilator, antibacterial, or antihistaminic?

<p>Preliminary test (A)</p> Signup and view all the answers

What is the purpose of mechanism of action tests?

<p>To find out the mechanism of action (A)</p> Signup and view all the answers

What type of test is used to study the effects of a drug on major organ systems?

<p>Systemic pharmacology (C)</p> Signup and view all the answers

What is the purpose of acute toxicity tests?

<p>To determine the toxicity of the compound (C)</p> Signup and view all the answers

What type of test is used to study the absorption, distribution, and excretion of a drug?

<p>Pharmacokinetics (D)</p> Signup and view all the answers

What is the purpose of general observational tests?

<p>To observe the overt effects of a drug (B)</p> Signup and view all the answers

What type of test is used to confirm and characterize the activity of a drug?

<p>Confirmatory test (A)</p> Signup and view all the answers

What is the purpose of quantitative tests?

<p>To ascertain the dose-response relationship (D)</p> Signup and view all the answers

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