Introduction to Clinical Pharmacology –
Complete Test Bank with Questions and
Answer Rationales
What is the definition of clinical pharmacology? - answers 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 _____ - answers
pharmacodynamics and pharmacokinetics
What is the definition of translational sciences? - answers 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? - answers one tenth of LD50 for cancer or
phytotoxins
What are the professional goals of clinical pharmacologists? - answers 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? - answers risk/benefit ratio
What is the characteristic of Risk/Benefit ratio? - answers 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 - answers 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 - answers 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? - answers 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 - answers HLA-B*1502 and Carbamazepine
What is the name of drug-induced disease associated with HLA-B*1502? - answers
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 - answers 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? - answers 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 _____ - answers Terfenadine Carboxylate, Terfenadine, and
Fexofenadine
What would we learn from the examples of Terfenadine and its carboxylic metabolite? -
answers 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 - answers Thalidomide
What is the starting step in development and evaluation of new drugs? - answers 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? - answers 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? -
answers Post-marketing studies
What are done in Pre-Clinical Development? - answers 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? - answers 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? - answers 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? - answers Typically, it is considered first dose in human
studies and dose escalations are evaluated to assess tolerance
What is studied in Phase II? - answers 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? - answers 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? - answers 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? - answers Phase I and II
In the context of "Learn and Confirm" Paradigm, which phase is defined as the
Confirmatory phase? - answers 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? - answers Phase IV
What is the definition of Drug Repurposing? - answers Finding new biological targets
and new therapeutic indications for "old" drugs
What may be the advantages from Drug Repurposing? - answers 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 _____ - answers Thalidomide and Erythema Nodosum Leprosum
What are the uses of PK studies? - answers 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? - answers Positron emission tomography scan
(PET scan)
What is the central tenet of pharmacology? - answers Dose-Response Relationship
What is the significance of careful study of "drug exposure-response" relationships? -
answers 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
How would you define drug exposure-response relationships? - answers PK/PD
modeling approaches are used
What is "Target concentration strategy"? - answers It is applied based on observed
individual variation in drug exposure (e.g., AUC) when using "standard" doses and it is
Complete Test Bank with Questions and
Answer Rationales
What is the definition of clinical pharmacology? - answers 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 _____ - answers
pharmacodynamics and pharmacokinetics
What is the definition of translational sciences? - answers 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? - answers one tenth of LD50 for cancer or
phytotoxins
What are the professional goals of clinical pharmacologists? - answers 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? - answers risk/benefit ratio
What is the characteristic of Risk/Benefit ratio? - answers 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 - answers 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 - answers 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? - answers 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 - answers HLA-B*1502 and Carbamazepine
What is the name of drug-induced disease associated with HLA-B*1502? - answers
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 - answers 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? - answers 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 _____ - answers Terfenadine Carboxylate, Terfenadine, and
Fexofenadine
What would we learn from the examples of Terfenadine and its carboxylic metabolite? -
answers 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 - answers Thalidomide
What is the starting step in development and evaluation of new drugs? - answers 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? - answers 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? -
answers Post-marketing studies
What are done in Pre-Clinical Development? - answers 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? - answers 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? - answers 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? - answers Typically, it is considered first dose in human
studies and dose escalations are evaluated to assess tolerance
What is studied in Phase II? - answers 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? - answers 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? - answers 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? - answers Phase I and II
In the context of "Learn and Confirm" Paradigm, which phase is defined as the
Confirmatory phase? - answers 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? - answers Phase IV
What is the definition of Drug Repurposing? - answers Finding new biological targets
and new therapeutic indications for "old" drugs
What may be the advantages from Drug Repurposing? - answers 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 _____ - answers Thalidomide and Erythema Nodosum Leprosum
What are the uses of PK studies? - answers 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? - answers Positron emission tomography scan
(PET scan)
What is the central tenet of pharmacology? - answers Dose-Response Relationship
What is the significance of careful study of "drug exposure-response" relationships? -
answers 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
How would you define drug exposure-response relationships? - answers PK/PD
modeling approaches are used
What is "Target concentration strategy"? - answers It is applied based on observed
individual variation in drug exposure (e.g., AUC) when using "standard" doses and it is
