Introduction to Clinical Pharmacology 9th 10th Edition
Visovsky Zambroski Hosler Test Bank
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 _____ - ANSWER: pharmacodynamics 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? - ANSWER: Stevens-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? - ANSWER: Drug 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
Basic studies of drug distribution
What is the tech used for basic studies of drug distribution that actually visualizes the binding of drugs
to its site of action? - ANSWER: Positron emission tomography scan (PET scan)
What is the central tenet of pharmacology? - ANSWER: Dose-Response Relationship
What is the significance of careful study of "drug exposure-response" relationships? - ANSWER: It is
aimed to finding "the right dose" for a given therapeutic indication which applies to both drug efficacy
and toxicity for a given therapeutic indication
Visovsky Zambroski Hosler Test Bank
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 _____ - ANSWER: pharmacodynamics 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? - ANSWER: Stevens-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? - ANSWER: Drug 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
Basic studies of drug distribution
What is the tech used for basic studies of drug distribution that actually visualizes the binding of drugs
to its site of action? - ANSWER: Positron emission tomography scan (PET scan)
What is the central tenet of pharmacology? - ANSWER: Dose-Response Relationship
What is the significance of careful study of "drug exposure-response" relationships? - ANSWER: It is
aimed to finding "the right dose" for a given therapeutic indication which applies to both drug efficacy
and toxicity for a given therapeutic indication
