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A 65-year-old female is hospitalized after a diagnosis of acute myocardial infarction complicated by recurrent episodes of ventricular tachycardia while being monitored in the critical care unit. The patient also has a history of congestive heart failure (CHF) and physical examination revealed peripheral edema and a congested mildly tender liver. The patients weighs 70 kg, and treatment is instituted with an initial 70 mg dose of intravenous lidocaine infused slowly over 2 minutes. Estimated lidocaine distribution volume (Vd) is 1.0 L/kg. Due to the diagnosis of CHF the elimination half-life (T1/2) is estimated at 4 hours (approximately twice normal). What maintenance infusion rate will provide a steady-state plasma lidocaine level of 5 micrograms/mL in this patient?
A. 1.0 mg/min
B. 2.5 mg/min
C. 5.0 mg/min
D. 10.0 mg/min
]Some clinical situations require administration of a loading (initial) dose of a drug to establish a therapeutic plasma concentration without delay. This may be done giving a large initial dose orally but the intravenous (IV) route of administration is often required. Which of the following is a determinant of the initial plasma concentration of a drug given by rapid IV infusion (bolus dose)?
A. The first-order distribution rate constant
B. The elimination clearance rate
C. The central compartment volume of distribution
D. The intercompartmental clearance rate
A drug that competes with an agonist for the same or overlapping site on the receptor is known as a
A. Noncompetitive antagonist
B. Competitive antagonist
C. Functional antagonist
True or False: A drug is cleared by a zero-order process. Therefore, the AUC of the drug will double if the dose is doubled.
A. True
B. False
The trough concentration for an aminoglycoside from your patient is much higher than the target trough concentration. After holding the next dose, you should:
A. Increase the dosage interval
B. Decrease the dosage interval
C. Increase the dose
D. Decrease the dose
True or False: The administration of a single dose of an investigational product (e.g., pharmacokinetic
or PK study) generally does not offer a prospect of direct benefit to the individual child enrolled in the study.
A. True
B. False
A patient presents with Chronic Myelogenous Leukemia (CML) and treatment is planned with
imatinib. The medical history suggests your patient used to be morbidly obese. She has undergone a gastric
bypass a year ago, and currently has a normal BMI. Which of the following is correct?
A. If you could get a blood sample analyzed, you could confirm whether systemic exposure is similar to
published values.
B. Because she has a normal size now, the normal dose of imatinib can be used.
C. You have no idea what the effect of her specific surgical procedures is on the absorption of imatinib.
D. Like most drugs, imatinib gets absorbed from the intestine, so a “gastric” bypass is not relevant for the
absorption of imatinib.
E. A and C
True or False: Positron emission tomography (PET) studies involve the injection of a radioactively
labeled drug that emits a particle called a positron.
A. True
B. False
During the third trimester of pregnancy, the percent protein binding of theophylline has been shown
to be 13%. Typical fluid volumes for such patients are 21 L for extracellular fluid space and 40 L for total body water. Based on this data, what would be the expected distribution volume of theophylline?
A. 24 L
B. 28 L
C. 32 L
D. 38 L
E. 45 L
True or False: The only difference between the compartmental and noncompartmental methods of
analysis is in how the nonaccessible portion of the system is described.
A. True
B. False
Which of the following is true regarding transporters?
A. Inhibition of intestinal uptake transporters does not change the absorption of drugs
B. Inhibition of intestinal efflux transporters will increase the bioavailability of drugs administered
intravenously
C. Transporters are membrane proteins that move substrates, including drugs, into or out of cells
During clinical trials, fedratinib, a Janus Kinase inhibitor, was found to cause thiamine (Vitamin B1)
deficiency in a group of patients. Please indicate which of the following statements is most consistent with this observation.
A. Fedratinib inhibited the efflux pump, P-glycoprotein, which is localized to the apical membrane of the
intestine.
B. Fedratinib inhibited the thiamine transporter, THTR2 (SLC19A3), found on the apical membrane of the
intestine.
C. Fedratinib stimulated the thiamine transporter, THTR2 (SLC19A3), found on the apical membrane of the
intestine.
D. Thiamine inhibited the efflux pump, P-glycoprotein, which is localized to the apical membrane of the
intestine.
E. Fedratinib inhibited the active secretion of thiamine in the kidney by MATE1 (SLC47A1).
Factors that determine drug transport across the blood brain barrier include all of the following
except
A. Lipid solubility
B. Charge at physiological pH
C. Renal function
D. Protein binding
E. Presence of efflux transporters
What are the indications for continuous renal replacement therapy in a critically ill patient?
A. Removal of excess fluid because of fluid overload
B. Clinical need to administer fluid to someone who is oliguric
C. Administer nutrition solutions
D. Administer parenteral antibiotics
E. All of the above
The advantages of SLED include
A. Inflexible patient schedule
B. Need for custom replacement solutions
C. Hemodynamic stability
D. Need for special support staff
E. Need for expensive continuous renal replacement machines
Amoxicillin provides coverage for anthrax infection, but not during pregnancy. Why is this true?
A. The bacterial susceptibility patterns are different in pregnancy.
B. Amoxicillin is hepatically cleared, and hepatic clearance is increased in pregnancy.
C. Amoxicillin is renally cleared, and renal clearance is increased in pregnancy.
D. Amoxicillin is highly protein bound, and protein binding is increased in pregnancy which decreases the
free fraction of drug.
Which of the following statements regarding the care of pregnant women are true?
A. Pregnant women have a higher mortality rate from influenza.
B. Pregnant women may have opioid withdrawal signs and symptoms despite taking the labeled dose of
buprenorphine.
C. Increased volume of distribution during pregnancy produces lower drug concentrations.
D. Increased clearance during pregnancy produces lower drug concentrations.
E. Both A and B
F. A, B, C, and D are all correct
Which of the following are reasons for developing a disease progression model?
A. Clinical trial simulation for improving study designs
B. Projecting patient improvement with different treatment options
C. Development of a response surface provides more information to the caregiver to individualize
treatment with a new drug
D. All of the above
E. None of the above
All of the following represent advantages of immunotherapy over conventional targeted therapy or
chemotherapy except
A. No adverse effects have been reported with immunotherapies
B. Responses with immunotherapies are durable
C. With immunotherapies, antigen spreading leads to a broader therapeutic response
The fundamental particle of quantum mechanics is the electron, as describing its motion and
energetics is the goal of the Schrödinger equation. What is the fundamental particle of molecular mechanics?
A. It is the same – the electron
B. It is the atom
C. It is the molecule
D. The Fermi boson
E. There are no particles
True or False: Pediatric deaths in the US in 1905 from patent medicines, and in 1936 from
sulfanilamide dissolved in diethylene glycol, and malformations in Europe and other countries from thalidomide, were direct precursors to laws regulating drug safety and efficacy.
A. True
B. False
The four categories of the Biopharmaceutics Classification System (BCS) is established based on two
key biopharmaceutical properties. They are:
A. The intrinsic dissolution rate and partition rate of the drug
B. The aqueous solubility in the human GI fluid and the intestinal permeability of the drug
C. The solubility in octanol solvent and the partition coefficient (Log P) of the drug
D. The aqueous solubility in the human GI fluid and the partition coefficient (Log P) of the drug
The dose number is defined as: Dose # = Dose/[Cs *250 mL]. Drug A possesses an aqueous solubility,
Cs, of 0.1 mg/mL in human GI fluid. The dose number of Drug A with a targeted dose of 100 mg is:
A. 0.4
B. 4
C. 10
D. 40
Which of the following research area are important for the prioritization of natural product “hit”
extracts?
A. Biological
B. Biochemical
C. Chemical Metabolomics
D. Taxonomic
E. All of the above
Administering T-cells genetically engineered with retroviruses has been associated with the following
toxicities
A. Leukemias in children with hereditary immunodeficiency
B. Detection of replication competent retroviruses in some recipients
C. Autonomous growth of T-cell clones
D. None of the above
The U.S. FDA is responsible for regulation of all of the following except:
A. The cost of marketed drug and biologic products
B. Veterinary products
C. Cosmetic products
D. Pre-market safety of investigational drug and biologic products
E. Post-marketing safety of marketed drug and biologic products
All of the following are expedited programs at the FDA except:
A. Accelerated Approval
B. Special Protocol Assessment
C. Breakthrough Therapy Designation
D. Priority Review
E. Fast Track Designation
You would like to initiate mercaptopurine in a patient with intermediate TPMT activity. Which of the
following is the most reasonable approach?
A. TMPT activity is not relevant in mercaptopurine dosing so no dose adjustment is required
B. Use of mercaptopurine is contraindicated in this population so therapy should not be initiated
C. Increase the initial dose by 30-60%
D. Decrease the initial dose by 30-60%
CPIC guidelines are intended to inform clinicians how to use genetic information to guide prescribing.
All of the following are considered to be clinically actionable gene/drug pairs for prescribing except for which of the following:
A. Mercaptopurine/TPMT
B. Ondansetron/CYP2D6
C. Cisplatin/GSTM1
D. Tacrolimus/CYP3A5
E. Fluorouracil/DPYD
A safety signal could be:
A. New, previously unknown, adverse event
B. New drug interaction
C. An observed change in quantity, severity or the affected populations of a known adverse event
D. All of the above
A. 1.0 mg/min
B. 2.5 mg/min
C. 5.0 mg/min
D. 10.0 mg/min
]Some clinical situations require administration of a loading (initial) dose of a drug to establish a therapeutic plasma concentration without delay. This may be done giving a large initial dose orally but the intravenous (IV) route of administration is often required. Which of the following is a determinant of the initial plasma concentration of a drug given by rapid IV infusion (bolus dose)?
A. The first-order distribution rate constant
B. The elimination clearance rate
C. The central compartment volume of distribution
D. The intercompartmental clearance rate
A drug that competes with an agonist for the same or overlapping site on the receptor is known as a
A. Noncompetitive antagonist
B. Competitive antagonist
C. Functional antagonist
True or False: A drug is cleared by a zero-order process. Therefore, the AUC of the drug will double if the dose is doubled.
A. True
B. False
The trough concentration for an aminoglycoside from your patient is much higher than the target trough concentration. After holding the next dose, you should:
A. Increase the dosage interval
B. Decrease the dosage interval
C. Increase the dose
D. Decrease the dose
True or False: The administration of a single dose of an investigational product (e.g., pharmacokinetic
or PK study) generally does not offer a prospect of direct benefit to the individual child enrolled in the study.
A. True
B. False
A patient presents with Chronic Myelogenous Leukemia (CML) and treatment is planned with
imatinib. The medical history suggests your patient used to be morbidly obese. She has undergone a gastric
bypass a year ago, and currently has a normal BMI. Which of the following is correct?
A. If you could get a blood sample analyzed, you could confirm whether systemic exposure is similar to
published values.
B. Because she has a normal size now, the normal dose of imatinib can be used.
C. You have no idea what the effect of her specific surgical procedures is on the absorption of imatinib.
D. Like most drugs, imatinib gets absorbed from the intestine, so a “gastric” bypass is not relevant for the
absorption of imatinib.
E. A and C
True or False: Positron emission tomography (PET) studies involve the injection of a radioactively
labeled drug that emits a particle called a positron.
A. True
B. False
During the third trimester of pregnancy, the percent protein binding of theophylline has been shown
to be 13%. Typical fluid volumes for such patients are 21 L for extracellular fluid space and 40 L for total body water. Based on this data, what would be the expected distribution volume of theophylline?
A. 24 L
B. 28 L
C. 32 L
D. 38 L
E. 45 L
True or False: The only difference between the compartmental and noncompartmental methods of
analysis is in how the nonaccessible portion of the system is described.
A. True
B. False
Which of the following is true regarding transporters?
A. Inhibition of intestinal uptake transporters does not change the absorption of drugs
B. Inhibition of intestinal efflux transporters will increase the bioavailability of drugs administered
intravenously
C. Transporters are membrane proteins that move substrates, including drugs, into or out of cells
During clinical trials, fedratinib, a Janus Kinase inhibitor, was found to cause thiamine (Vitamin B1)
deficiency in a group of patients. Please indicate which of the following statements is most consistent with this observation.
A. Fedratinib inhibited the efflux pump, P-glycoprotein, which is localized to the apical membrane of the
intestine.
B. Fedratinib inhibited the thiamine transporter, THTR2 (SLC19A3), found on the apical membrane of the
intestine.
C. Fedratinib stimulated the thiamine transporter, THTR2 (SLC19A3), found on the apical membrane of the
intestine.
D. Thiamine inhibited the efflux pump, P-glycoprotein, which is localized to the apical membrane of the
intestine.
E. Fedratinib inhibited the active secretion of thiamine in the kidney by MATE1 (SLC47A1).
Factors that determine drug transport across the blood brain barrier include all of the following
except
A. Lipid solubility
B. Charge at physiological pH
C. Renal function
D. Protein binding
E. Presence of efflux transporters
What are the indications for continuous renal replacement therapy in a critically ill patient?
A. Removal of excess fluid because of fluid overload
B. Clinical need to administer fluid to someone who is oliguric
C. Administer nutrition solutions
D. Administer parenteral antibiotics
E. All of the above
The advantages of SLED include
A. Inflexible patient schedule
B. Need for custom replacement solutions
C. Hemodynamic stability
D. Need for special support staff
E. Need for expensive continuous renal replacement machines
Amoxicillin provides coverage for anthrax infection, but not during pregnancy. Why is this true?
A. The bacterial susceptibility patterns are different in pregnancy.
B. Amoxicillin is hepatically cleared, and hepatic clearance is increased in pregnancy.
C. Amoxicillin is renally cleared, and renal clearance is increased in pregnancy.
D. Amoxicillin is highly protein bound, and protein binding is increased in pregnancy which decreases the
free fraction of drug.
Which of the following statements regarding the care of pregnant women are true?
A. Pregnant women have a higher mortality rate from influenza.
B. Pregnant women may have opioid withdrawal signs and symptoms despite taking the labeled dose of
buprenorphine.
C. Increased volume of distribution during pregnancy produces lower drug concentrations.
D. Increased clearance during pregnancy produces lower drug concentrations.
E. Both A and B
F. A, B, C, and D are all correct
Which of the following are reasons for developing a disease progression model?
A. Clinical trial simulation for improving study designs
B. Projecting patient improvement with different treatment options
C. Development of a response surface provides more information to the caregiver to individualize
treatment with a new drug
D. All of the above
E. None of the above
All of the following represent advantages of immunotherapy over conventional targeted therapy or
chemotherapy except
A. No adverse effects have been reported with immunotherapies
B. Responses with immunotherapies are durable
C. With immunotherapies, antigen spreading leads to a broader therapeutic response
The fundamental particle of quantum mechanics is the electron, as describing its motion and
energetics is the goal of the Schrödinger equation. What is the fundamental particle of molecular mechanics?
A. It is the same – the electron
B. It is the atom
C. It is the molecule
D. The Fermi boson
E. There are no particles
True or False: Pediatric deaths in the US in 1905 from patent medicines, and in 1936 from
sulfanilamide dissolved in diethylene glycol, and malformations in Europe and other countries from thalidomide, were direct precursors to laws regulating drug safety and efficacy.
A. True
B. False
The four categories of the Biopharmaceutics Classification System (BCS) is established based on two
key biopharmaceutical properties. They are:
A. The intrinsic dissolution rate and partition rate of the drug
B. The aqueous solubility in the human GI fluid and the intestinal permeability of the drug
C. The solubility in octanol solvent and the partition coefficient (Log P) of the drug
D. The aqueous solubility in the human GI fluid and the partition coefficient (Log P) of the drug
The dose number is defined as: Dose # = Dose/[Cs *250 mL]. Drug A possesses an aqueous solubility,
Cs, of 0.1 mg/mL in human GI fluid. The dose number of Drug A with a targeted dose of 100 mg is:
A. 0.4
B. 4
C. 10
D. 40
Which of the following research area are important for the prioritization of natural product “hit”
extracts?
A. Biological
B. Biochemical
C. Chemical Metabolomics
D. Taxonomic
E. All of the above
Administering T-cells genetically engineered with retroviruses has been associated with the following
toxicities
A. Leukemias in children with hereditary immunodeficiency
B. Detection of replication competent retroviruses in some recipients
C. Autonomous growth of T-cell clones
D. None of the above
The U.S. FDA is responsible for regulation of all of the following except:
A. The cost of marketed drug and biologic products
B. Veterinary products
C. Cosmetic products
D. Pre-market safety of investigational drug and biologic products
E. Post-marketing safety of marketed drug and biologic products
All of the following are expedited programs at the FDA except:
A. Accelerated Approval
B. Special Protocol Assessment
C. Breakthrough Therapy Designation
D. Priority Review
E. Fast Track Designation
You would like to initiate mercaptopurine in a patient with intermediate TPMT activity. Which of the
following is the most reasonable approach?
A. TMPT activity is not relevant in mercaptopurine dosing so no dose adjustment is required
B. Use of mercaptopurine is contraindicated in this population so therapy should not be initiated
C. Increase the initial dose by 30-60%
D. Decrease the initial dose by 30-60%
CPIC guidelines are intended to inform clinicians how to use genetic information to guide prescribing.
All of the following are considered to be clinically actionable gene/drug pairs for prescribing except for which of the following:
A. Mercaptopurine/TPMT
B. Ondansetron/CYP2D6
C. Cisplatin/GSTM1
D. Tacrolimus/CYP3A5
E. Fluorouracil/DPYD
A safety signal could be:
A. New, previously unknown, adverse event
B. New drug interaction
C. An observed change in quantity, severity or the affected populations of a known adverse event
D. All of the above
