Exam 2: Stages Of Drug Development II - Pre-clinical, GLP Flashcards
According to the Roche video on target identification, there are several approaches to finding a candidate drug target. What is not one of Roche approach?
A) Mutating one gene at a time in a model animal to see whether the mutation leads to a disease phenotype
B) Identifying the protein target of a traditional drug, like aspirin
C) Using proteomics to Identify which proteins bind to or interact with an active chemical substance
D) Studying genes in healthy and diseased individuals to find a gene or genes that may be defective in the diseased individual
E) Counting the number of bacterial colony forming units growing on a plate
E) Counting the number of bacterial colony forming units growing on a plate
As part of in vitro, pre-clinical research, the Ames test is performed using bacteria to determine which property of a candidate drug?
A) The ability of a drug to promote bacterial cell division
B) The ability of a drug to increase heart rate in trial animals
C) The ability of a drug to cause elevation of liver enzyme activity in mice
D) None of the other choices are correct
E) The ability of a drug to cause abortion in a pregnant mouse
D) None of the other choices are correct
With FDA’s Modenization Act 2.0, FDA will no longer require animal testing prior to testing of investigational drugs in humans. What is not a motivation for the enactment of the new rules on animal testing?
A) Animal are not able to communicate pain to investigators
B) Animal testing are more often wrong than right in predicting the effects of drugs on humans
C) There are alternative, predictive pre-clinical tests, including organs on a chip.
D) Animal testing slows down the drug development process
E) Animal testing costs drug companies millions in dollars
A) Animal are not able to communicate pain to investigators
Choose the best answer. If required by FDA, in pre-clinical animal testing, the FDA would usually expect biologics to be tested in:
A) Of mice and men
B) One small mammal and a primate
C) One small mammal and one large mammal like a dog
D) Two small and two large mammals
E) One mammal
B) One small mammal and a primate
What is not a part of in vivo pre-clinical research?
A) Determine efficacy of drug in animals
B) Determine how the drug affects heart physiology in mice
C) Determine possible changes in the levels of liver enzymes
D) Modifying the chemical structure of a known drug to optimize binding to a protein target
E) Evaluate changes in certain biomarkers that would indicate that the drug is active
D) Modifying the chemical structure of a known drug to optimize binding to a protein target
Which is not true of Good Laboratory Practices?
A) GLPs protect the integrity and quality of pre-clinical laboratory data submitted to the FDA
B) Started because of questionable pre-clinical documentation in a clinic involved in human drug trials
C) GLP regulations are found in CFR21 Part 58
D) Followed for any lab activity that will be used to support product submission to FDA
E) Made up of regulations and guidances that govern laboratory studies in animals
B) Started because of questionable pre-clinical documentation in a clinic involved in human drug trials
The OECD published a series of principles of Good Laboratory Practices and Compliance Monitoring. What does not apply to the OECD and the GLP principles?
A) OECD stands for Organization for Economic Cooperation and Development
B) The shared GLP principles will help eliminate trade barriers for tested chemicals among member countries
C) The OECD is an FDA department in charge of GLP regulations
D) The GLPs and monitoring will promote mutual acceptance of non-clinical safety data for drug submissions in member countries.
C) The OECD is an FDA department in charge of GLP regulations
The main goal of pre-clinical animal testing is to determine the ______________starting dose to use in initial clinical trials for therapeutics in healthy human volunteers.
A) Minimum toxic starting dose
B) Maximum effective starting dose
C) Maximum safe starting dose
D) Minimum safe starting dose
E) Minimum effective starting dose
C) Maximum safe starting dose
A _______________is the drug, biologic, or device under development, while the ________________ is any article other than the former that is administered to animals to serve as basis for comparison with the former.
A) Component: Active pharmaceutical ingredient
B) Formulation: Excipient
C) Patent medicine: adulterated drug
D) Test article: Control article
E) Control article: Test article
D) Test article: Control article
Which of the following GLP activities is not the main responsibility of the Quality Assurance unit?
A) Quality assurance checks to be sure that no deviations from approved protocols were made without proper authorization and documentation
B) Quality assurance designates or replaces the Study Director
C) Quality assurance reviews final study reports to ensure that the reported results are accurate
D) Quality assurance reviews final study reports to ensure accurate listing of the protocols that were followed
E) Quality assurance is in charge of inspecting and auditing each nonclinical laboratory study
B) Quality assurance designates or replaces the Study Director
What is not a GLP requirement regarding equipment in animal testing laboratories?
A) Protocols for use of the equipment needs to be written and followed
B) Equipment should be cleaned whenever they become noticeably dirty
C) Written records of equipment use and maintenance should be kept
D) Equipment needs to be properly maintained and calibrated according to schedule or when needed.
E) Equipment size and design should be appropriate for its use
B) Equipment should be cleaned whenever they become noticeably dirty
During pre-clinical research, a starting lead compound usually requires optimization of one or more of its properties. What is not a property of a lead compound that researchers attempt to optimize?
A) Improving binding specificity of the drug to a target protein
B) Decreasing the drug’s adverse health effects
C) In some cases, broaden inhibition of multiple targets
D) Increasing the drug’s affinity for lead
E) Better uptake by the body
D) Increasing the drug’s affinity for lead
What information is usually not included in completed animal study reports per GLP?
A) Changes to or deviations from procedures
B) Chemical synthesis of the active pharmaceutical ingredient
C) Gross post-mortem observations
D) Statistical analysis, calculations, and other mathematical operations done on data
E) Procedures that were followed
B) Chemical synthesis of the active pharmaceutical ingredient
What is not correct about the regulation of animal research under the Animal Welfare Act of 1966?
A) The Animal Welfare Act aims to reduce the number of primates used in animal testing
B) The Animal Welfare Act states that tests and experiments should be refined to ensure the best conditions for the animals
C) The Animal Welfare Act is enforced by Bioresearch Monitoring Office of the FDA
D) The Animal Welfare Act sets standards regarding the housing, feeding, cleanliness, and medical care of research animals
E) The Animal Welfare Act encourages replacing animals with alternative models where possible
C) The Animal Welfare Act is enforced by Bioresearch Monitoring Office of the FDA
What applies to an animal facility that had been disqualified by the FDA for serious GLP violations?
A) All studies completed in the testing site cannot be considered in support of application for marketing.
B) The non-compliant facility is not entitled to a regulatory hearing
C) The facility will be forever banned from conducting animal tests
D) Study sponsor can still use information that were generated with non-GLP compliant practices
E) Facility can be reinstated upon implementation of corrective actions.
E) Facility can be reinstated upon implementation of corrective actions.
