Pharmacology and Drug Trials Overview

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Questions and Answers

Which of the following is an example of a placebo?

  • Herbal medication with no known effect
  • Physiotherapy
  • Sham surgery (correct)
  • Cognitive behavioural therapy

Phase 1 clinical trials primarily assess which of the following?

  • Dosing
  • Efficacy
  • Safety (correct)
  • Pharmacodynamics

In which phase of clinical trials is the efficacy of a new drug compared with that of an existing drug?

  • Phase II
  • Phase III (correct)
  • Phase IV
  • Phase I

What does pharmacovigilance refer to?

<p>Monitoring of drug safety (D)</p> Signup and view all the answers

Phase 4 clinical trials are conducted for which purpose?

<p>After a drug is marketed (C)</p> Signup and view all the answers

Flashcards

Placebo

A sham treatment or procedure, like a fake pill or surgery, used for comparison in clinical trials. It helps determine if the real medication is effective due to its properties or simply a psychological effect.

Phase 1 Clinical Trials

The first phase in clinical trials, focusing on safety and dosage of a new medicine. It is typically done on a small group of healthy volunteers.

Phase III Clinical Trials

The stage in clinical trials where a new drug is compared against an existing treatment to determine its effectiveness (efficacy). It involves larger groups of patients.

Pharmacovigilance

The continuous process of monitoring the safety risks of medications after they are released to the market. It's crucial to track potential side effects or problems.

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Phase IV Clinical Trials

A type of clinical trial carried out after a drug is sold to the public. Its goal is to gather long-term data on benefits, risks, and optimal uses of the drug. It's often done for specific populations or for broader insights.

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Study Notes

Question 1

  • A placebo is a substance with no known effect, like herbal medication with no known effect or sham surgery

Question 2

  • Phase 1 clinical trials assess drug safety

Question 3

  • Phase III clinical trials compare a new drug (B) to an existing drug (A) to assess efficacy.

Question 4

  • Pharmacovigilance is the monitoring of drug safety.

Question 5

  • Phase 4 clinical trials occur after a drug is marketed and assess its use in various populations, including pediatric patients and those with rare diseases.

Question 6

  • A pandemic is a global disease outbreak. Specific details on recent pandemics or personal experiences are not included in the provided text.

Question 7

  • The question asks for COVID-19 vaccines developed in India. Specific vaccines are not mentioned.

Question 8

  • "Off-label" use of a drug is using it for a purpose not approved by regulatory bodies. No examples for the COVID-19 pandemic are provided.

Question 9

  • "Fast Track Approval" is a process to expedite drug/vaccine approval for urgent medical needs, and examples from the COVID-19 pandemic are not mentioned.

Question 10

  • Pharmacovigilance is critical during pandemics to monitor risks and side effects in widespread use of drugs/vaccines.

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