L3 SAQ Pharmaceutical Regulatory Authorities Quiz

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What are the phases of clinical trials?

Phase IV, Phases 1-III

What are the types of drug interactions?

Agonists and antagonists

What are the types of drug targets?

Proteins and others

What are the two important stages in the regulatory process for new drugs?

Investigational New Drug (IND) and New Drug Application (NDA) Signup and view all the answers

Name the regulatory authorities in the United States and Ireland.

Food and Drug Administration (FDA) and Health Products Regulatory Authority (HPRA) Signup and view all the answers

What is the purpose of blinding in clinical trials?

To minimize bias and make patient attitudes to the trial as similar as possible in treatment and control groups Signup and view all the answers

What are the three principles outlined in the Belmont Report for patient protection in research?

Respect for persons, beneficence, and justice Signup and view all the answers

Why is it important to register clinical trials?

To ensure transparency and prevent bias in reporting of trial results Signup and view all the answers

What are the various stages of clinical trials and their purpose?

Phase I Trials: Clinical Pharmacology and Toxicity: 20-80 subjects Phase II Trials: Efficacy and safety testing in a small number of patients (100-300) Phase III Trials: Full-scale Evaluation of Treatment. Large-scale efficacy and safety testing in substantial numbers of patients (1000-3000) Phase IV Trials: Post-marketing Surveillance for drugs administered over long periods of time Signup and view all the answers

What is the rationale of clinical trials?

To elucidate the most appropriate treatment of future patients with a given medical condition Signup and view all the answers

What are the phases of clinical development?

Phase Ia, Phase Ib, Phase IIa, Phase IIb, Phase III, Phase IV Signup and view all the answers

What are the characteristics of a Phase 3 trial?

Randomization to groups, Placebo controlled, Compared against current best treatment, Well-defined protocol Signup and view all the answers

Who is responsible for organizing the great majority of clinical trials?

Pharmaceutical companies Signup and view all the answers

What is the clinical need for effective pharmacotherapy for obesity?

There is a clinical need for effective pharmacotherapy for obesity. Signup and view all the answers

What is the design of the study?

The study is a phase 3, randomised, double-blind, placebo-controlled, multicentre trial. Signup and view all the answers

What are the co-primary endpoints of the study?

The co-primary endpoints of the study are the percentage change in weight from baseline to week 72 and weight reduction of at least 5% by week 72. Signup and view all the answers

What were the average weight reductions with the 10-mg and 15-mg doses of tirzepatide?

The average weight reductions with the 10-mg and 15-mg doses of tirzepatide were 19.5% and 20.9%, respectively. Signup and view all the answers

What is the incidence of adverse events in the 10-mg and 15-mg groups?

The incidence of adverse events was similar in the 10-mg and 15-mg groups. Signup and view all the answers

What are the endogenous ligands for opioid receptors?

Endorphins and enkephalins Signup and view all the answers

List five opioid agonist drugs.

Morphine, codeine, bupernorphine, heroin, fentanyl Signup and view all the answers

Name an opioid antagonist drug.

Naloxone Signup and view all the answers

What are the opioid receptor subtypes?

m, d, k & NOP Signup and view all the answers

What is the difference between codeine and morphine?

Codeine is much less potent than morphine, making it less addictive Signup and view all the answers

What is the mechanism of action of naloxone?

It is a m receptor antagonist, attenuating analgesia and euphoria Signup and view all the answers

What is the endogenous catecholamine neurotransmitter released from nerve terminals?

Noradrenaline Signup and view all the answers

What is the main effect of adrenaline (epinephrine) activation of b receptors?

Tachycardia and increased respiration rate Signup and view all the answers

What is the mechanism of action of propranolol?

It is a nonselective b receptor antagonist, reducing heart rate and blood pressure Signup and view all the answers

Name two NSAIDs mentioned in the text.

Aspirin, ibuprofen Signup and view all the answers

What is the role of COX in prostaglandin synthesis?

COX is responsible for converting arachidonic acid into cyclic endoperoxides in the synthesis of prostaglandins. Signup and view all the answers

How do aspirin and ibuprofen act as COX inhibitors?

Aspirin and ibuprofen inhibit the activity of COX, thereby reducing the production of prostaglandins. Signup and view all the answers

What is the effect of aspirin on platelet aggregation?

Aspirin inhibits platelet aggregation. Signup and view all the answers

What is the relationship between plasma cholesterol and cardiovascular conditions?

Elevated plasma cholesterol is a risk factor for cardiovascular conditions. Signup and view all the answers

What is the mechanism of action of statins in reducing plasma cholesterol?

Statins inhibit the enzyme HMG-CoA reductase, which is involved in cholesterol synthesis, leading to a reduction in plasma cholesterol levels. Signup and view all the answers

How does cocaine enhance the effects of dopamine?

Cocaine acts as a dopamine reuptake blocker, leading to enhanced dopamine effects. Signup and view all the answers

What is the mechanism of action of SSRIs like fluoxetine?

SSRIs inhibit the reuptake of serotonin, leading to enhanced serotonin effects. Signup and view all the answers

How do benzodiazepines like diazepam affect GABA-A receptors?

Benzodiazepines, such as diazepam, act as agonists at GABA-A receptors, leading to increased chloride channel opening and hyperpolarization. Signup and view all the answers

What is the role of CB1 receptors in the effects of THC?

THC acts as a CB1 receptor agonist, which contributes to its effects on neurotransmission. Signup and view all the answers

How do benzodiazepines like diazepam affect air-puff-elicited ultrasonic vocalization in rats?

Diazepam inhibits air-puff-elicited ultrasonic vocalization in rats. Signup and view all the answers