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

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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?

Prescription requirements Signup and view all the answers

Which of the following is NOT a drug development phase?

Pilot Production Signup and view all the answers

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

To ensure accurate prescribing and dispensing Signup and view all the answers

What is the main purpose of phase 1 clinical trials?

Evaluate safety and tolerability in healthy human volunteers Signup and view all the answers

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

8-10 years Signup and view all the answers

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

Detecting any rare or long-term adverse effects Signup and view all the answers

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

Phase 2 Signup and view all the answers

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

Control the scheduling of drugs and poisons Signup and view all the answers

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

Compare the investigational new drug with existing treatments or placebo Signup and view all the answers

What is the purpose of the Poisons Standard?

To classify medicines and poisons into Schedules for inclusion in legislation. Signup and view all the answers

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

Schedule 8 Signup and view all the answers

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

Schedule 2 Signup and view all the answers

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

To control drug availability to the public. Signup and view all the answers

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

Schedule 1 Signup and view all the answers

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

Schedule 3 requires a prescription while Schedule 4 doesn't. Signup and view all the answers

What is the role of TGA in Australia?

Regulating the supply, import, export, and manufacturing of medicines, medical devices, and blood products Signup and view all the answers

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

The brand name is easier to remember and is patented, while the chemical name is descriptive but usually long and difficult to remember 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?

Phase III: Therapeutic confirmatory Signup and view all the answers

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

To detect and monitor adverse effects or long-term efficacy of marketed drugs Signup and view all the answers

What is the main goal of clinical development of drugs?

To gather data on safety and efficacy leading to drug approval Signup and view all the answers

How do chemical names of drugs differ from generic names?

Chemical names are derived from the molecular structure, while generic names are invented for easy recall Signup and view all the answers

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

To prevent confusion and mistakes in prescribing/dispensing Signup and view all the answers

Which government department in Australia is responsible for drug control?

Department of Health Signup and view all the answers

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

Registered medicines must provide safety data Signup and view all the answers

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

TGA Signup and view all the answers

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

To improve the evaluation of listed medicines for efficacy Signup and view all the answers

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

To prevent mistakes in prescribing/dispensing Signup and view all the answers