Test Bank For Introductory Clinical Pharmacology 12th Edition
By Susan
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
By Susan
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
