Clinical Trials and Placebo Effects Flashcards
What is the purpose of Phase 1 clinical trials?
Phase 1 trials test a new drug on a small group of healthy individuals to determine its safety, pharmacokinetics, pharmacodynamics, and identify any adverse effects.
What are the objectives of Phase 2 and Phase 3 clinical trials?
Phase 2 trials test the efficacy of a drug on individuals with the disease, assess safety further, and determine the best dosage. Phase 3 trials confirm the drug’s effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow safe marketing.
What is the placebo effect in clinical trials?
The placebo effect occurs when patients experience benefits from an inactive substance due to expectations of improvement. This effect is significant in assessing the true efficacy of drugs.
Describe the key steps in the FDA drug approval process.
The process includes basic research, pre-clinical testing, clinical trials (Phases 1-3), and FDA review, which evaluates the drug’s safety, efficacy, and risk management before approval.
How does THC affect the body pharmacologically?
THC acts as an agonist at cannabinoid receptors, notably CB1 receptors in the brain, affecting neurotransmitter release and leading to effects such as euphoria, altered cognition, and increased appetite.
What are some potential long-term adverse effects of cannabis use?
Long-term cannabis use can lead to changes in brain structure, including reduced hippocampal and orbitofrontal cortex volume, and may increase the risk of psychiatric disorders like schizophrenia.
What are some approved medical uses of cannabis?
cannabis is approved for medical use in various conditions including chronic pain, severe nausea from chemotherapy, and muscle spasticity in multiple sclerosis
What factors increase the risk of developing cannabis use disorder?
Early initiation of use, frequent and intensive use, and the use of high-potency cannabis products are significant risk factors for developing cannabis use disorder.
What are risk management strategies in drug approval?
Risk management strategies may include specific labeling, monitoring programs, and in some cases, a Risk Evaluation and Mitigation Strategy (REMS) to manage potential risks associated with a drug.
What is the purpose of Phase 4 clinical trials?
hase 4 trials, conducted after a drug is marketed, gather additional information on the drug’s long-term effects, optimal use, and safety in a broader patient population
What are signs of cannabis use disorder (CUD)?
Signs of CUD include difficulties controlling use, disruptions in functioning, increased tolerance, and withdrawal symptoms, affecting users’ personal and professional lives.
What factors affect drug absorption?
Factors influencing drug absorption include the drug formulation, administration route, rate of dissolution, and the presence of food or other drugs in the system
What are drug-drug interactions?
Drug-drug interactions occur when two or more drugs react with each other, potentially altering the effectiveness or increasing the risk of adverse effects
Why are clinical trials important in drug development?
Clinical trials test the safety and efficacy of drugs in humans, providing essential data that inform dosing, administration, and potential side effects
Name a specific adrenoceptor agonist and its clinical use
Salbutamol, an adrenoceptor agonist, is commonly used to treat asthma by relaxing bronchial muscles and improving airflow