Introduction to Clinical Pharmacology 2023 Test Bank Exam Questions With 100% Verified Answers

Introduction to Clinical Pharmacology 2023 Test Bank Exam Questions With 100% Verified Answers What is the definition of clinical pharmacology? - ANSWER- A discipline spanning the spectrum of drug delivery, drug development, drug utilization, and drug regulation What are the words for the following blanks? Clinical Pharmacology is aimed at advancing therapeutics in humans with mechanistic understanding of drug actions _____ and drug disposition _____ - ANSWERpharmacodynamics and pharmacokinetics What is the definition of translational sciences? - ANSWER- Knowledge acquired in animal or in silico models of disease, ex-vivo studies in human tissues, or in vivo studies in healthy or diseased humans is translated into effective treatment for patients What is the starting dose of Phase I trial? - ANSWER- one tenth of LD50 for cancer or phytotoxins What are the professional goals of clinical pharmacologists? - ANSWER- Discover, develop and evaluate new medicines, regulate their use Optimize the use of existing medicines, find new indications Define the basis for variability in therapeutic and toxic responses to medicines What is the measurement to see whether some toxicities can be managed and may be acceptable? - ANSWER- risk/benefit ratio What is the characteristic of Risk/Benefit ratio? - ANSWER- It is contextual, which tells you it is depending on the drug and disease that we intend to treat For example, it is not the same to consider potentially serious toxicity for a drug intended to treat HYT, which is a medical condition that needs lifelong therapy, compared to treatment of cancer, a disease that is potentially lethal over the short term, and that requires very intense treatment with combination of drugs that have very significant toxicity _____ is a condition or brings up situations, if you will, where an underlying genetic variant may predispose individuals to severe toxicity to drugs - ANSWER- Genetics What is the name of genetic variant and the name of antiviral drug? Individuals that carry _____ variant are at very high risk of _____ hypersensitivity. This drug is used in the treatment of HIV infections and AIDS, and prior to instituting treatment with the drug, every pt is first tested for this variant, _____, and alternatives must be found if the patient have the variant - ANSWER- HLA-B*5701 and abacavir What is the name drug that causes the-drug-induced liver disease (DILI) and the name of variant associated with this DILI? - ANSWER- Flucoxacillin and HLA-B *5701 What is the name of genetic variant and the name of drug? _____ may predispose to severe _____-induced, a serious cutaneous ADR that actually can be fatal - ANSWER- HLA-B*1502 and Carbamazepine What is the name of drug-induced disease associated with HLA-B*1502? - ANSWERStevens-Johnson syndrome What is the name of disease exemplified as unacceptable drug toxicity that induces an abnormal, life-threatening episode/ADR of the polymorphic ventricular tachycardia that you might be able to see in ECG record - ANSWER- Torsades de Pointes What is the name of drug that was historically the first non-sedating antihistamine under the brand name of Seldane, but subsequently withdrawn from the market due to the risk of drug-induced arrhythmias? - ANSWER- Terfenadine What are the words in the blanks? _____ is carboxylic metabolite of _____ which is a non-sedating antihistamine under the brandname of Allegra but does not have the risk of a drug-induced arrhythmia. Recently it is also called _____ - ANSWER- Terfenadine Carboxylate, Terfenadine, and Fexofenadine What would we learn from the examples of Terfenadine and its carboxylic metabolite? - ANSWER- It brings us to consider and remember the importance of studying drug metabolism and assessing whether metabolites are also pharmacologically active or are otherwise inactive ones, whether transformation has taken place What is the name of drug that was not allowed to enter the US market after approved in the US due to some severe toxicity to unborn children expressed by prenatal drug exposure: an epidemic worldwide of phocomelia, children born with severe defects in terms of their limbs - ANSWER- Thalidomide What is the starting step in development and evaluation of new drugs? - ANSWERDrug discovery What is the step that animal testing of candidate drugs and evaluation to demonstrate safety in humans and whether or not the drug is effective in a given clinical condition while conducted in development and evaluation of new drugs? - ANSWER- Pre-clinical and clinical evaluation What is the step in which, once the drug enters the market, experts continue to evaluate for the possibility of rare ADRs that were not discovered in the pre-approval stage, and also performing studies in special populations like geriatric and pediatric populations? - ANSWER- Post-marketing studies What are done in Pre-Clinical Development? - ANSWER- Chemical Synthesis and Formulation Development Animal Models for Efficacy Assay Development Animal PK and PD Animal Toxicology What is the case for which Animal Toxicology continues in the long term? - ANSWER- If the drug is intended for chronic use What is the next step once a package of information is developed that indicates the candidate drug may, in fact, be promising? - ANSWER- An investigational new drug application, the IND, is filed with the FDA or other regulatory agencies and process of evaluating the drug in humans starts by Clinical Development: Phase I, Phase II, and Phase III What is studied in Phase I? - ANSWER- Typically, it is considered first dose in human studies and dose escalations are evaluated to assess tolerance What is studied in Phase II? - ANSWER- The proof of concept studies is done by treating patients with the condition that may benefit, potentially from the drugs What is studied in Phase III? - ANSWER- The large randomized clinical trials are conducted by comparing the new drug to a placebo or to a previously established therapy What would we see after Phase III is finished up? - ANSWER- The finish leads to the submission of a new drug application, or NDA, where the sponsor asks the regulatory agents to review this body of evidence and request approval for marketing of the drug and to begin using the drug in clinical practice at hospitals In the context of "Learn and Confirm" Paradigm, which phase is defined as the Learning phase? - ANSWER- Phase I and II In the context of "Learn and Confirm" Paradigm, which phase is defined as the Confirmatory phase? - ANSWER- Phase III In the context of "Learn and Confirm" Paradigm, which phase is defined as the Postmarketing phase in which learning continues with focus on ADRs and special populations if required? - ANSWER- Phase IV What is the definition of Drug Repurposing? - ANSWER- Finding new biological targets and new therapeutic indications for "old" drugs What may be the advantages from Drug Repurposing? - ANSWER- It may shorten drug development time because we already know a lot about the safety of the drug (e.g., Prior human safety data), and we also have data in terms of the human PK behavior of the drug (e.g., Known human PK) What is the name of drug and medical condition filled in the following blanks? _____ had withdrawn from the US market due to severe defect outcome to infants but by "drug repurposing", now it becomes useful an immunomodulatory agent in a clinical condition like _____ - ANSWER- Thalidomide and Erythema Nodosum Leprosum What are the uses of PK studies? - ANSWER- Basis for rational dose selection in therapeutics Development and evaluation of new drugs