DEVELOPING DRUGS Flashcards
(18 cards)
What happens in the FDA review phase of drug testing and development?
-FDA reviews data from all clinical trials and lab studies.
-Ensures the drug is safe and effective for its intended use.
-Can take 6–10 months (standard) or 6 months (priority review).
-If approved, the drug can be marketed and prescribed.
-FDA also reviews labelling and manufacturing practices.
What happens in the FDA post-market safety monitoring?
-FDA continuously monitors drug safety once it’s on the market.
-Collects and reviews adverse event reports from healthcare providers and patients.
-Can issue warnings, recalls, or restrictions if safety issues arise.
-May require additional studies (Phase IV) for long-term safety and effectiveness.
Double blind trial:
-Neither the participants nor the researchers know who is getting the treatment or placebo.
-Prevents bias in treatment administration and results interpretation.
-Helps ensure the reliability and accuracy of the study findings.
Side effects:
Unwanted or unexpected effects of a drug or treatment.
Can range from mild (nausea, headache) to serious (organ damage).
Always monitored during clinical trials and after approval.
How does clinical testing take place?
-Clinical testing happens in 4 phases (I to IV) to check safety and effectiveness.
-Starts with small groups of volunteers (Phase I) and moves to larger patient groups (Phases II & III).
-Uses controlled conditions with placebos and sometimes double-blind methods to avoid bias.
-After approval, Phase IV monitors the drug in the wider population for long-term effects.
How do drugs affect our bodies?
-Drugs interact with cells and chemicals in the body to produce effects.
-They can mimic or block natural chemicals (like hormones or neurotransmitters).
-Can change how organs and systems work normally (e.g., lowering blood pressure).
-Some drugs treat illness, while others can cause side effects if not used properly.
Why may people take drugs?
-To treat or prevent illness (e.g., antibiotics for infections).
-To relieve symptoms like pain or fever (e.g., painkillers).
-To improve mental health (e.g., antidepressants).
-Sometimes for recreational reasons (which can be harmful or illegal).
-To enhance performance (e.g., some athletes use banned substances).
When can people make sensible decisions about drugs?
-When they have accurate information about the drug’s benefits and risks.
-After understanding how the drug affects the body.
-When they know the correct dosage and how to use it safely.
-If they have advice from trusted healthcare professionals.
-When they avoid peer pressure and think about long-term effects.
Preclinical drug testing:
-Happens before testing on humans.
-Involves laboratory and animal experiments.
-Tests if the drug is safe and effective in living cells and animals.
-Helps find possible side effects and the right dose to try in humans.
-Only if results are good, the drug moves on to clinical trials.
Types of drugs:
-Medicinal drugs: Used to treat or prevent illness (e.g., antibiotics, painkillers).
-Recreational drugs: Taken for pleasure but can be harmful (e.g., alcohol, nicotine, cannabis).
-Performance-enhancing drugs: Used to improve physical or mental abilities (e.g., steroids).
-Illegal drugs: Banned because they’re dangerous or addictive (e.g., heroin, cocaine).
Thalidomide:
Thalidomide is a drug that was originally used to treat morning sickness in pregnant women.
What was thalidomide found to be effective in?
Thalidomide was found to be effective in treating morning sickness in pregnant women.
Today, it’s also used to treat some conditions like certain cancers and leprosy-related inflammation but under strict controls because of its risks.
Why was thalidomide banned and what did this cause?
-Thalidomide was banned because it caused severe birth defects in babies when taken by pregnant women.
-This tragedy led to much stricter drug testing regulations and safety laws worldwide.
-It made sure that all new drugs are tested thoroughly for side effects before being approved.
What has thalidomide been successful in the treatment of?
-Thalidomide has been successful in treating:
-Leprosy, especially to reduce inflammation and skin sores.
-Multiple myeloma (a type of blood cancer).
-It’s used carefully because of its serious side effects.
Statins:
-Statins are drugs that lower cholesterol levels in the blood.
-They help reduce the risk of heart disease and stroke.
-Work by blocking an enzyme involved in making cholesterol in the liver.
-Often prescribed to people with high cholesterol or heart problems.
What does a high cholesterol level increase the risk of?
-High cholesterol increases the risk of heart disease and stroke.
-It can cause fatty deposits (plaques) to build up in arteries, narrowing them (atherosclerosis).
-This can lead to blocked blood flow, causing heart attacks or strokes.
What does the long-term use of statins reduce?
-Long-term use of statins reduces the risk of heart attacks and strokes.
-It lowers bad cholesterol (LDL) levels, helping keep arteries clear.
-Helps prevent damage to the heart and blood vessels over time.
Why are people concerned about the use of statins?
-Some people worry about side effects like muscle pain, liver problems, or digestive issues.
-Concerns about taking a drug long-term when feeling healthy.
-Some fear over-reliance on medication instead of healthy lifestyle changes.
