GMS 6551 FINAL SPECIAL EXAM 2025

Which definition best describes a lead compound? - -The first compound discovered to have the desired activity. What method of discovering a drug is generally the least expensive? - -Molecular docking What is the name of the process that involves step-wise alteration of a drug to improve its properties? - -Structure activity relationship What was the estimated research and development expenses of pharma in 2016? - -60 billion What branch of pharmacology studies the effect of the body on the drug? - Pharmacokinetics What branch of pharmacology studies how patients respond differently to drugs? - Pharmacogenetics What branch of pharmacology studies the desired effect of drugs on the body, usually at the molecular level? - -Pharmacodynamics What branch of pharmacology studies adverse effects of drugs on the body? - Toxicology What branch of pharmacology does excretion fall under? - -Pharmacokinetics Which is the chemical name for a popular OTC painkiller? - -N-acetyl-para-aminophenol What is the proprietary name for a popular OTC painkiller? - -Tylenol Which is the non-proprietary name for a popular OTC painkiller? - -Acetaminophen Which of the following are OTC drugs in the U.S.? Select all that Apply - Diphenhydramine (Benadryl) Loperamide (Diarrhea) 6-tert-butyl-3-(4,5-dihydro-1H-imidazol-2-ylmethyl)-2,4-dimethylphenol;hydrochloride (Nasal constriction) Which of the following are prescription drugs in the U.S.? Select all that apply. - Codeine Levothyroxine (Hypothyroidism) Tadalafil (Erectile dysfunction) GMS 6551 GMS 6551 Sally receives a year-long prescription from her physician for low-dose codeine that allows for 11 refills. Her pharmacist will refuse to honor the full prescription because this is a schedule _____ controlled substance. - -III List four drugs containing the suffix -mab. What does the suffix denote? - -Sotrovimab Casirivimab Alemtuzumab Efalizumab -mab is nomenclature that identifies monoclonal antibodies. List one example drug each for the schedule 1- schedule V classifications. - -Schedule I- Rohypnol Schedule II- Amytal Schedule III- Bontril Schedule IV- Lunesta Schedule V- Lyrica Why do you think the FDA promotes orphan drugs? - -Less profits involved developing orphan drugs (drugs that treat rarer diseases) since the won't be used as often. More money in more popular drug development. A drug discovery program is only as good as its assay. WHY? - -If the assay is poor the drug discovery/ development process can not move forward. The assay process is when the drug is tested on its intended target to get a desired interaction. A good assay will help identify the drug target which then should lead way to identifying the lead compound. What inherent conflict does the legalization of medical marijuana create with the federal laws governing controlled substances? - -The federal government can still punish someone with marijuana, even if it's prescribed to them, even though the state has made it legal. Marijuana is a schedule 1 controlled substance and under federal law can not be prescribed. What stage of translational research is the first to utilize a FDA approved drug? - -T3 For which of the following parts of translational research is patient involvement critical? - -Public Health Basic Research Pre-Clinical Research Clinical Research Clinical Implementation GMS 6551 GMS 6551 The transition between which two phases of translational research involves switching from controlled settings to real-world settings? - -T2-T3 Which type of drug is most likely to be given orally? - -Small Molecule Overnight contact lenses are considered class ___ medical devices? - -Class III What term describes the process of taking a piece of human tumor from a pt and placing it under the skin of a mouse in order to do pre-clinical testing? - -Patient-derived xenograft In order to do a clinical trial in humans, IRB approval must be obtained. From which regulatory body must approval be obtained in order to carry out a similar study in rats? - -IACUC Gaining information on which of the following is the primary purpose of a Phase I clinical trial? - -Treatment safety Which of the following requires direct action by a patient (or guardian) before they can be enrolled in a phase I clinical trial? - -Informed consent In which type of clinical trial is a MTD most likely to be determined? - -Phase 1 What government agency regulates phase I clinical trails in the US? - -FDA A clinical trial for the use of a new painkiller in terminal cancer patients who have been admitted to hospice would be considered what type of clinical trial? - -Quality of life trial How many groups of pts would be required for a placebo-controlled factorial trail to test combinations of three drugs? - -8 In which type of clinical trial is every pt guaranteed to receive active drug? - -Cross-over trail Which of the following would you most expect to be an exclusion criterion for a clinical trial for a new therapy for pediatric leukemia? - -Pt is greater than 12 years old. What is a bidirectional continuum? - -There is not a beginning that the research HAS to start at. The process can start from anywhere and move in any direction. It is not a linear process. Who is the person in charge of the IRB at UF? - -Peter Lafrate What are two reasons a pt may choose to participate in a phase 1 trial? - -Other treatment options have been unsuccessful or they may not have any other treatment options available. GMS 6551 GMS 6551 What's the average cost of a phase III clinical trial? - -Between 11.5 million and 52.9 million. See Questions 21-28 to review other topics - -Endometriosis examples What is the most common drug target? - -Receptors Gleevec targets - -Enzymes Once insulin reaches the pancreas, how long do you expect it to take before a response can be measured? - -Minutes A dose of agonist occupies 30% of receptors and gives an effect of 50. According to the occupancy theory, what effect would you expect from a dose that occupies 90% of receptors? - -150 Naloxone binds to the opioid receptor, preventing opioids from binding, therefore preventing an effect. In this situation, naloxone is a(n)_____ and the opioid is a(n)_____. - -Antagonist; agonist Most drugs bind in such a way that it is reversible without a chemical reaction. These drugs must therefore lack which type of bond with their targets? - -Covalent Drug A requires 15 uM to reach 50% of its max response while Drug B requires 50 uM to reach 50% of its max response. Which drug is more potent? - -Drug A Drug A requires 15 uM to reach 50% of its max response while Drug B requires 50 uM to reach 50% of its max response. Which drug is more efficacy? - -Cannot tell Which term describes a molecule that produces an effect when binding a receptor but is incapable of inducing a %100 effect? - -Partial agonist The addition of a competitive antagonist will affect the apparent ____ of an agonist. - Potency The addition of a non-competitive antagonist will affect the apparent ____ of an agonist. - -Efficacy When Drug A, an agonist, is given chronically, larger and larger concentration are needed in order to achieve the same effect. Which phenomenon is likely occurring? - Desensitization Which type of response curve would you look at if you wanted to know the exact response predicted in a controlled system at a specified drug concentration? - -Graded concentration response GMS 6551 GMS 6551 When developing a new drug, do you generally want a high or low therapeutic index? - High Aspirin has an ED50= 5 mg/dL and a TD50= 100 mg/dL. What is the therapeutic index of aspirin? - -20 How would you determine which drug is more potent? - -Which ever drug reaches 50% of its max response at a lower dose is more potent How could you tell whether an agonist is paired with a competitive antagonist or a non competitive antagonist? - -If an agonist is paired with a competitive antagonist you'll see a decrease in the drugs affinity and potency. If the agonist is paired with a non competitive antagonist you will see the efficacy change but not the potency. Rebound congestion. How does this occur? - -If the nasal decongestant was an antagonist it was blocking agonists being released by the body. Once the antagonist is removed the accumulated agonist made by the body is able to bind to the increased amount of receptors on the cells surface. EC50 - -Used for cell-culture ED50 - -Measures the dose of the drug given to get a 50% response. Measures the dose that 50% of individuals exhibit a therapeutic effect. Knowing the ED50 and the toxicity levels in humans can help determine the therapeutic window of a drug. Anti-cancer drugs have a smaller therapeutic index. Why? - -The drugs therapeutic dose is very close to the toxic dose. Don't have a specific target like antibiotics do. Through which route is warfarin usually administered? - -Orally Through which route of administration will at least some first-pass metabolism occur? - Oral, Rectal Would you expect aspirin to be absorbed better in high or low pH? - -Low pH Would you expect a more polar or nonpolar drug to have more bioavailability? - Nonpolar Assuming same lipophilicity and that all charges are neutral, which drug would you expect to have the best membrane permeability? - -Tylenol Which family of enzymes catalyzes the majority of phase I drug metabo