B 4.1 Drugs and Clinical trails Flashcards
(13 cards)
What are clinical trials?
Tests done on new medicines to check their safety, effectiveness, and dosage before they are licensed.
What are the main stages of clinical trials?
Preclinical testing (in labs and animals)
Clinical trials on healthy volunteers (low doses)
Clinical trials on patients (test effectiveness and side effects)
Why are clinical trials done in phases?
To ensure safety and to find the correct dosage without harming people.
What is a placebo?
A substance with no active drug used in clinical trials to test if the drug’s effect is real.
What is a double-blind trial?
A trial where neither the patient nor the doctor knows who receives the real drug or the placebo to avoid bias.
Why must drugs be tested thoroughly before licensing?
To ensure they are safe, effective, and do not cause harmful side effects.
What is the purpose of clinical trials?
To test the safety and effectiveness of a new drug in humans.
What is the difference between a placebo and an active drug in clinical trials?
A placebo is a dummy treatment with no active ingredient; an active drug contains the substance being tested.
Why are double-blind trials used in drug testing?
To prevent bias because neither the patient nor the doctor knows who receives the placebo or the active drug.
What ethical considerations must be taken into account during clinical trials?
Informed consent, patient safety, confidentiality, and the right to withdraw.
Why is it important to test drugs on healthy volunteers before patients?
To assess safety and side effects without the interference of illness.
What is meant by a blind trial?
The patient does not know whether they are receiving the drug or a placebo.
How do drugs become licensed for general use?
After successful clinical trials proving safety and effectiveness, regulatory authorities approve the drug.
