Unit 7 Lilley Chpt 4

  1. any systemic error in a measurement process. One common effort to avoid bias in research studies involves the use of blinded study designs
  2. a type of warning that apprears in a drug’s prescribing information, required by the U.S. Food and Drug Administration alerting prescribers of serious adverse events that have occurred with the given drug
    Black box warning
  3. A research designed in which the subjects are
    purposely aware of whether the substance they are administered is the drug under study or the placebo. This method serves to eliminate bias on the part of research subjects in reporting their body’s response to investigational drugs
    Blinded Investigational Drug Study
  4. any drugs listed on one of the “schedules” of the controlled substance act (also called scheduled drugs)
    Controlled Substances
  5. A research design in which both the investigator
    (s) and the subjects are purposely unaware of whether the substance administered to a given subject is the drug under study or a placebo. This method eliminates bias on the part of both the investigator and the subject
    Double-blind Investigational Drug Study
  6. variation in response to a drug because of a patient’s age, gender, size and/or body composition
    Drug polymorphism
  7. Acceleration of the usual investigational new drug approval process by the U.S. Food and Drug Administration (FDA) and pharmaceutical
    companies, usually for drugs used to treat life-threatening disease
    Expedition Drug Approval
  8. An act that protects health insurance coverage for workers and their families when they change jobs. It
    also protects patient’s information. If confidentiality of a patient is breached, severe fines may be imposed
    • Health Insurance Portability and Accountability Act
    • (HIPPA)
  9. Written permission obtained from a patient consenting to the performance of a specific procedure (e.g., receiving an investigational drug),
    after the patient has been given information regarding the procedure deemed necessary for the
    patient to make a sound or “informed” decision
    Informed Consent
  10. a drug not approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy; also, the actual name of the category of application that the drug manufacturer submits to the FDA to obtain permission for human (clinical)studies following successful completion
    of animal
    Investigational new Drug (IND)
  11. The type of application that a drug manufacturer submits the FDA following successful completion of required human research studies
    Investigational New Drug Application
  12. another name for prescription drugs
    Legend Drugs
  13. a legal term established under the Harrison
    Antinarcotic Act of 1914. It originally applied to drugs that produced insensibility or stupor, especially the opioids (e.g., morphine, heroin). The term is currently used in clinical settings to refer to any medically administered controlled substance and in legal settings to refer to any illicit or “street”
  14. A special category of drugs that have been identified to help treat patients with rare diseases
    Orphan Drug
  15. Drugs available to consumers without a prescription. Also called nonprescription drugs
    Over-the-counter Drugs
  16. an inactive 9inert) substance (e.g., saline, distilled water, starch, sugar), that is not a drug but is formulated to resemble a drug for research purposes
Card Set
Unit 7 Lilley Chpt 4
Unit 7 Lilley Chapter 4