Health Canada and Drug Approval Process in Canada

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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'?

A physiological effect Signup and view all the answers

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

Pharmacokinetics Signup and view all the answers

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

Monitoring drug safety post-approval Signup and view all the answers

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

Health Products and Food Branch (HPFB) Signup and view all the answers

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

Introduction to drug regulations in Canada Signup and view all the answers

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

Ensuring drug quality, safety, and efficacy Signup and view all the answers

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

Differentiate between atrial fibrillation and atrial flutter Signup and view all the answers

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

Treatment of atrial fibrillation Signup and view all the answers

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

For conditions related to the heart Signup and view all the answers

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

Conventional drugs and natural health products Signup and view all the answers

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

Identifying the advantages and disadvantages of prescription and over the counter drugs Signup and view all the answers

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

Hormones, antibodies, vaccines Signup and view all the answers

Which advance enabled the development of recombinant human insulin?

Cloning human insulin cDNA Signup and view all the answers

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

Insulin therapy using insulin from porcine or bovine pancreas Signup and view all the answers

Which category includes natural plant extracts and dietary supplements?

Natural Health Products Signup and view all the answers

What is required prior to a patient receiving Prescription Drugs?

Dispensing order from a qualified health care professional Signup and view all the answers

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

To evaluate the drug's safety and possible adverse effects in healthy subjects Signup and view all the answers

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

Clinical trial data, indication, adverse effects, production, and packaging information Signup and view all the answers

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

To identify benefits and risks associated with the drug 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?

Both are required for marketing the drug Signup and view all the answers

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

Health Canada continues to evaluate drug safety and efficacy through quality assurance processes Signup and view all the answers