L3 SAQ Pharmaceutical Regulatory Authorities Quiz

Phase IV, Phases 1-III

Agonists and antagonists

Proteins and others

<p>Investigational New Drug (IND) and New Drug Application (NDA)</p> Signup and view all the answers

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

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

<p>Respect for persons, beneficence, and justice</p> Signup and view all the answers

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

<p>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</p> Signup and view all the answers

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

<p>Phase Ia, Phase Ib, Phase IIa, Phase IIb, Phase III, Phase IV</p> Signup and view all the answers

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

<p>Pharmaceutical companies</p> Signup and view all the answers

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

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

<p>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.</p> Signup and view all the answers

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

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

<p>Endorphins and enkephalins</p> Signup and view all the answers

<p>Morphine, codeine, bupernorphine, heroin, fentanyl</p> Signup and view all the answers

<p>Naloxone</p> Signup and view all the answers

<p>m, d, k &amp; NOP</p> Signup and view all the answers

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

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

<p>Noradrenaline</p> Signup and view all the answers

<p>Tachycardia and increased respiration rate</p> Signup and view all the answers

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

<p>Aspirin, ibuprofen</p> Signup and view all the answers

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

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

<p>Aspirin inhibits platelet aggregation.</p> Signup and view all the answers

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

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

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

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

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

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

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