L3 MCQ Pharmaceutical Regulatory Authorities Quiz

Clinical Trials

• Phases of clinical trials: I (exploratory safety and efficacy testing), II (efficacy and dosage), III (large-scale efficacy and safety testing), and IV (post-marketing surveillance)
• Phase I involves exploratory safety and efficacy testing in patients
• Phase II involves efficacy and dosage testing
• Phase III involves large-scale efficacy and safety testing in substantial numbers of patients
• Phase IV involves post-marketing surveillance
• Purpose of Phase II trials: to evaluate efficacy and optimal dosage
• Key characteristic of a Phase 3 trial: large-scale efficacy and safety testing

Systematic Reviews and Meta-Analysis

• Purpose of systematic reviews: to evaluate drugs by systematically reviewing and synthesizing data
• Purpose of meta-analysis: to quantitatively combine data from multiple studies to draw conclusions

Drug Targets and Mechanisms

• Measure of a drug's potency: EC50 (effective concentration 50%)
• Type of drug target: receptor, enzyme, etc. (but not "disease" or "symptom")
• Tirzepatide: GLP-1 receptor agonist

Clinical Trial Methodology

• Purpose of blinding in a clinical trial: to reduce bias
• Purpose of registering clinical trials: to ensure transparency and accountability
• Purpose of the methods section in a trial report: to provide detailed descriptions of the study design, procedures, and statistical analyses

Regulatory Agencies and Ethics

• US regulatory authority founded in 1930: FDA (Food and Drug Administration)
• Purpose of the Belmont Report: to outline ethical principles for human subjects research
• Three principles of the Belmont Report: respect for persons, beneficence, and justice

Pharmacology

• Opioid antagonist: naloxone
• Opioid drug less potent than morphine: codeine
• Opioid receptor subtype activated by endorphins: mu (μ) receptor
• Beta receptor agonist: salmeterol
• Nonselective beta receptor antagonist: propranolol
• NSAID (non-steroidal anti-inflammatory drug): ibuprofen, etc. (but not aspirin)
• Opioid agonist: morphine
• Antagonist of the m receptor: atropine
• Endogenous opioid ligand: endorphin
• Opioid drug more addictive than codeine: heroin
• Enzyme responsible for prostaglandin synthesis: cyclooxygenase (COX)
• Primary function of thromboxanes: vasoconstriction and platelet aggregation
• Class of drugs that inhibits COX: NSAIDs
• Main strategy to reduce the risk of cardiovascular conditions associated with elevated plasma cholesterol: statins
• Enzyme targeted by statins to lower plasma cholesterol: HMG-CoA reductase
• Neurotransmitter affected by benzodiazepines: GABA (gamma-aminobutyric acid)
• Primary mechanism of action of THC: activation of CB1 receptors
• Effect of diazepam on GABA-A receptors: positive allosteric modulation
• Relationship between cocaine and locomotor activity in mice: increased locomotor activity
• Primary effect of amphetamine on dopamine: increased release and inhibition of reuptake