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</p> Signup and view all the answers

    Which of the following is NOT a drug development phase?

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

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

    <p>Phase 2</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</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</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.</p> Signup and view all the answers

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

    <p>Schedule 8</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</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.</p> Signup and view all the answers

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

    <p>Schedule 1</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.</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</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</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</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</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</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</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</p> Signup and view all the answers

    Which government department in Australia is responsible for drug control?

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

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

    <p>TGA</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</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</p> Signup and view all the answers

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