Across
- 2. Studies that occur after FDA approves a drug to determine additional information about drugs’ risk, benefit, manufacturing, and optimal use. Often non-randomized. May also study new uses and indications.
- 7. the dose that kills approximately 50% of the animals; also may see written as LD50
- 8. Consent A process that provides research subjects with explanations to help them make educated decisions about starting or continuing participation in a research study or trial. It is an ongoing, interactive process. It does not waive the subject’s legal rights and it does not release the investigator or sponsor from liability for negligence.
- 10. A committee attached to a randomized clinical trial that is charged with the responsibility of monitoring performance of the trial, safety of the participants, and efficacy of the treatments being tested.
- 11. The initial introduction of an investigational new drug into humans. Typically closely monitored and may be conducted in patients or normal volunteers. Designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and if possible to gain early evidence of effectiveness. Usually small (20-80 pts) and uncontrolled
- 13. A formal request to FDA for a license to market a new drug in the US. Submitted when the sponsor believes there is enough safety and effectiveness data to meet FDA requirements. Application must contain data from specific technical viewpoints, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If approved, the product may be marketed in the US.
- 17. unblinded trial. These are easier to carry out and less expensive but have risk for bias. May be only option in some cases. More accurately reflects clinical practice
- 20. design that consists of alternating periods of administration of test drug, placebo preparation (control), and the standard treatment (positive control), if any, in each subject
- 21. The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease at the dose tested and against the illness (and patient population) for which it is designed.
- 22. A group of medical, scientific and non-scientific members formally designated to review and monitor biomedical research involving human subjects. The purpose is to assure that appropriate steps are taken to protect the rights and welfare of human subjects.
- 23. The desired measure of a drug’s influence on a disease or condition as demonstrated by substantial evidence from adequate and well-controlled investigations.
Down
- 1. the process of assigning patients to treatment using a random process
- 2. Expanded controlled trials that are performed after preliminary evidence suggest effectiveness of the drug has been obtained. Intended to demonstrate effectiveness and safety in a clinically and statistically meaningful way. Provide adequate basis for physician labeling. Often multi-center, large sample size. Can be designed to access superiority, equality, equivalence or noninferiority.
- 3. Conducted to evaluate the effectiveness of a drug for a particular indication/s in patients with the disease or condition under study. They are also used to determine the common short-term side effects and risks associated with the drug. May or may not have comparison group. Usually hundreds of patients (200-500)
- 4. the maximum dose at which a specified toxic effect is not seen.
- 5. the smallest dose that is observed to kill any experimental animal
- 6. a leading candidate for a successful new drug.
- 9. Drug developed for a rare disease.
- 12. an experiment that is done in the body of a living organism
- 14. harmful or unintended response from a drug
- 15. concealment (masking) to the patient (single blind), investigator (double blind) and the monitors (triple) of the identity of the intervention.
- 16. investigations that compare a test article (i.e. drug) with a treatment that has known effects. The control group may receive no treatment, active treatment, placebo or dose comparison concurrent control.
- 18. a substance or treatment that has no therapeutic effect.
- 19. A request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.
- 22. test that is done in glass or plastic vessels in the laboratory