W8: Introduction to Pharmacology Unit: Key Concepts and Drug Development
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Questions and Answers

What is the primary focus of pharmacology?

  • Understanding plant physiology
  • Development of new technologies
  • Study of how chemicals affect the body (correct)
  • Exploration of historical medicinal practices

Which organization plays a role in approving new drugs for the market in Australia?

  • FDA
  • TGA (correct)
  • EMA
  • WHO

At which phase of clinical development are drugs tested on a larger group of patients to assess safety and efficacy?

  • Phase 1
  • Phase 3 (correct)
  • Phase 4
  • Phase 2

What are the different drug scheduling categories meant to regulate?

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

Which of the following is NOT a drug development phase?

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

What is a primary reason for using chemical, generic, and brand names for pharmaceutical products?

<p>To ensure accurate prescribing and dispensing (C)</p> Signup and view all the answers

What is the main purpose of phase 1 clinical trials?

<p>Evaluate safety and tolerability in healthy human volunteers (C)</p> Signup and view all the answers

What is the typical duration of a drug development process, from discovery to market launch?

<p>8-10 years (C)</p> Signup and view all the answers

What is the primary focus of post-marketing surveillance of drugs?

<p>Detecting any rare or long-term adverse effects (C)</p> Signup and view all the answers

During which phase of drug development are human volunteers typically involved to determine efficacy?

<p>Phase 2 (C)</p> Signup and view all the answers

What is the purpose of Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)?

<p>Control the scheduling of drugs and poisons (C)</p> Signup and view all the answers

What is the primary goal of conducting a full-scale multicentre randomized double-blinded controlled clinical trial?

<p>Compare the investigational new drug with existing treatments or placebo (D)</p> Signup and view all the answers

What is the purpose of the Poisons Standard?

<p>To classify medicines and poisons into Schedules for inclusion in legislation. (B)</p> Signup and view all the answers

Which drug schedule category is considered a 'CONTROLLED DRUG'?

<p>Schedule 8 (A)</p> Signup and view all the answers

Under which drug schedule can 'PHARMACY MEDICINE' be obtained by the public with a pharmacist's advice?

<p>Schedule 2 (D)</p> Signup and view all the answers

What is the function of drug scheduling in relation to the public?

<p>To control drug availability to the public. (B)</p> Signup and view all the answers

Which schedule includes poisons of plant origin but is largely UNUSED?

<p>Schedule 1 (A)</p> Signup and view all the answers

What distinguishes Schedules 3 and 4 in terms of medicine availability?

<p>Schedule 3 requires a prescription while Schedule 4 doesn't. (A)</p> Signup and view all the answers

What is the role of TGA in Australia?

<p>Regulating the supply, import, export, and manufacturing of medicines, medical devices, and blood products (C)</p> Signup and view all the answers

What differentiates a brand name of a drug from a chemical name?

<p>The brand name is easier to remember and is patented, while the chemical name is descriptive but usually long and difficult to remember (C)</p> Signup and view all the answers

Which phase involves testing a new drug on a larger population to help determine dosages and instructive information to be contained in the drug label?

<p>Phase III: Therapeutic confirmatory (D)</p> Signup and view all the answers

What is the purpose of post-marketing surveillance of drugs?

<p>To detect and monitor adverse effects or long-term efficacy of marketed drugs (D)</p> Signup and view all the answers

What is the main goal of clinical development of drugs?

<p>To gather data on safety and efficacy leading to drug approval (B)</p> Signup and view all the answers

How do chemical names of drugs differ from generic names?

<p>Chemical names are derived from the molecular structure, while generic names are invented for easy recall (C)</p> Signup and view all the answers

What is the main purpose of using generic names instead of brand names for prescribing and dispensing drugs?

<p>To prevent confusion and mistakes in prescribing/dispensing (C)</p> Signup and view all the answers

Which government department in Australia is responsible for drug control?

<p>Department of Health (C)</p> Signup and view all the answers

What is the main difference between listed medicines and registered medicines in Australia?

<p>Registered medicines must provide safety data (A)</p> Signup and view all the answers

What regulatory body in Australia maintains the Australian Register of Therapeutic Goods (ARTG)?

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

What is the purpose of the new 'assessed listed medicines' pathway introduced by the TGA in 2020?

<p>To improve the evaluation of listed medicines for efficacy (A)</p> Signup and view all the answers

Why is it encouraged for prescribers and pharmacists to use generic names instead of brand names?

<p>To prevent mistakes in prescribing/dispensing (D)</p> Signup and view all the answers

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