Test your knowledge with this quiz!
Test your knowledge with this quiz!The AAPS Immunogenicity 101 ecourse features experts from varying disciplines lecturing on the nature of immune responses to biologically produced therapeutics; the analytical methods for detection and characterization of antibody responses; health authority concerns and expectations; the impact of immunogenicity on safety, efficacy, pharmacokinetics, and pharmacodynamics in preclinical and clinical studies; and tools and challenges for immunogenicity prediction, mitigation, and reporting during drug development. This ecourse consists of 28 lectures, divided into five modules, to support the growing biotechnology industry by providing convenient, yet thorough, online training from subject matter experts working in the field.
1. All antidrug antibody (ADA) responses have clinical consequences.
- True
- False
2. In a “tiered” ADA testing strategy, ADA samples are typically put through a series of tests in which order?
- Screen, characterize, titer
- Characterize, titer, screen
- Screen, confirm, characterize
- Screen, characterize, analyze
3. Which of the following is NOT typically associated with an increase in immunogenicity of a therapeutic protein?
- Tolerance is broken
- The patient is also receiving chemotherapy
- The drug contains aggregate
- The drug was improperly stored
4. ADAs can impact biologic therapeutics’
- safety
- efficacy
- pharmacokinetics
- all of the above
5. Which of the following is the best mechanism for determining the immunogenicity of a therapeutic protein?
- Studies using humanized mice
- In silico evaluation of the sequence of the drug to detect T-cell epitopes
- Nonclinical studies using cynomolgus monkeys
- Properly powered clinical trials
6. Validated ADA assays are required by the Food and Drug Administration for all phase 1 studies.
- True
- False
7. Which of the following is not an assay performance characteristics that should be validated for a screening assay:
- Lower and upper limits of quantitation
- Sensitivity
- Cut point
- Precision
- Selectivity
Check your answers below.
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ANSWER KEY:
1. B
2. C
3. B
4. D
5. D
6. B
7. A