Health Canada and Drug Approval Process in Canada

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24 Questions

What is the main focus of pharmacology?

Study of medications

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

Drug

What distinguishes a medication from a drug in pharmacological terms?

The type of therapeutic response targeted

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

A physiological effect

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

Pharmacokinetics

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

Monitoring drug safety post-approval

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

Health Products and Food Branch (HPFB)

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

Introduction to drug regulations in Canada

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

Ensuring drug quality, safety, and efficacy

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

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

Treatment of atrial fibrillation

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

For conditions related to the heart

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

Conventional drugs and natural health products

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

Identifying the advantages and disadvantages of prescription and over the counter drugs

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

Hormones, antibodies, vaccines

Which advance enabled the development of recombinant human insulin?

Cloning human insulin cDNA

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

Insulin therapy using insulin from porcine or bovine pancreas

Which category includes natural plant extracts and dietary supplements?

Natural Health Products

What is required prior to a patient receiving Prescription Drugs?

Dispensing order from a qualified health care professional

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

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

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

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

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

Explore the roles of Health Canada and the Health Products and Food Branch (HPFB) along with the stages of drug approval for therapeutic and biologic drugs in Canada. This quiz covers important concepts related to pharmacology and drug regulation in the Canadian healthcare system.

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