Health Canada and Drug Approval Process in Canada
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Questions and Answers

What is the main focus of pharmacology?

  • Study of medications (correct)
  • Study of animals
  • Study of physics
  • Study of plants

Which term best describes a substance capable of producing a biologic response?

  • Chemical compound
  • Drug (correct)
  • Vaccine
  • Medication

What distinguishes a medication from a drug in pharmacological terms?

  • The route of administration
  • The cost of production
  • The patent duration
  • The type of therapeutic response targeted (correct)

In pharmacology, what is meant by the term 'biologic response'?

<p>A physiological effect (A)</p> Signup and view all the answers

Which field focuses on the study of how the body processes medicine?

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

What is the role of Health Canada in the drug approval process?

<p>Monitoring drug safety post-approval (A)</p> Signup and view all the answers

Which branch of Health Canada is involved in the drug approval process?

<p>Health Products and Food Branch (HPFB) (B)</p> Signup and view all the answers

What is the main focus of Chapter 1 in 'Pharmacology for Nurses, Third Canadian Edition'?

<p>Introduction to drug regulations in Canada (C)</p> Signup and view all the answers

What is the significance of understanding the stages of drug approval for therapeutic and biologic drugs in Canada?

<p>Ensuring drug quality, safety, and efficacy (A)</p> Signup and view all the answers

Which of the following is NOT a learning outcome mentioned in the module on the 'introduction to pharmacology'?

<p>Differentiate between atrial fibrillation and atrial flutter (C)</p> Signup and view all the answers

What is the primary use of digoxin obtained from Digitalis purpurea?

<p>Treatment of atrial fibrillation (B)</p> Signup and view all the answers

In what context was the purple foxglove plant historically used before the identification of digoxin?

<p>For conditions related to the heart (A)</p> Signup and view all the answers

Which type of drugs are compared and contrasted in learning outcome LO4?

<p>Conventional drugs and natural health products (A)</p> Signup and view all the answers

What aspect of drug usage is examined in learning outcome LO5?

<p>Identifying the advantages and disadvantages of prescription and over the counter drugs (B)</p> Signup and view all the answers

What type of agents are produced by animal cells and microorganisms?

<p>Hormones, antibodies, vaccines (B)</p> Signup and view all the answers

Which advance enabled the development of recombinant human insulin?

<p>Cloning human insulin cDNA (D)</p> Signup and view all the answers

What type of therapy revolutionized diabetes treatment in the 1920s?

<p>Insulin therapy using insulin from porcine or bovine pancreas (A)</p> Signup and view all the answers

Which category includes natural plant extracts and dietary supplements?

<p>Natural Health Products (A)</p> Signup and view all the answers

What is required prior to a patient receiving Prescription Drugs?

<p>Dispensing order from a qualified health care professional (C)</p> Signup and view all the answers

What is the primary purpose of Phase I in clinical trials for a new drug?

<p>To evaluate the drug's safety and possible adverse effects in healthy subjects (D)</p> Signup and view all the answers

What is included in the New Drug Submission (NDS) submitted by the manufacturer to Health Canada?

<p>Clinical trial data, indication, adverse effects, production, and packaging information (B)</p> Signup and view all the answers

What is the purpose of the committee of drug experts in reviewing the New Drug Submission (NDS)?

<p>To identify benefits and risks associated with the drug (A)</p> Signup and view all the answers

What is the significance of Health Canada issuing a Drug Identification Number (DIN) and a Notice of Compliance to a manufacturer?

<p>Both are required for marketing the drug (A)</p> Signup and view all the answers

What occurs during Step 7 of the drug review and approval process in Canada?

<p>Health Canada continues to evaluate drug safety and efficacy through quality assurance processes (D)</p> Signup and view all the answers

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