1. Preclinical Testing: Laboratory tests performed on cells and animals using promising drug compounds to evaluate their safety and efficacy before they can be tested in humans.
2. Investigational New Drug (IND): An application that a drug sponsor (typically a pharmaceutical company) files with the FDA before beginning to test a new drug in humans.
3. Clinical Trials: The study of a potential new drug in people to evaluate its safety and effectiveness. They are typically conducted in four phases:
- Phase I: The drug is tested in a small group of healthy volunteers to evaluate its safety and dosage.
- Phase II: The drug is tested in a larger group of people to evaluate its effectiveness and further investigate its safety.
- Phase III: The drug is tested in large groups of patients to confirm its effectiveness, monitor side effects, compare it with commonly used treatments, and collect information that will allow it to be used safely.
- Phase IV: Post-marketing studies to garner further information including the drug's risks, benefits, and optimal use.
4. Placebo: An inactive substance (like a sugar pill) that's designed to mimic the drug being tested. It's used in clinical trials to provide a comparison for the new drug.
5. Double-Blind Study: A study in which neither the participants nor the researchers know which participants are receiving the active drug and which are receiving a placebo.
6. Active Control: A treatment known to be effective, against which the new drug can be compared in a clinical trial.
7. Adverse Event (AE): Any undesired actions or effects of the experimental drug or treatment.
8. New Drug Application (NDA): An application submitted by the maker of a drug to the FDA after clinical trials have been completed, requesting approval to market the drug.
9. Biologics License Application (BLA): Similar to an NDA, but specifically for biological products, such as vaccines or blood products.
10. Generic Drug: A drug that is comparable to a brand listed drug in dosage form, strength, route of administration, quality and performance characteristics, and intended use.
11. Orphan Drug: A drug developed to treat rare diseases or conditions.
12. Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and excreted by the body.
13. Pharmacodynamics: The study of the biochemical and physiological effects of drugs on the body.
14. Bioavailability: The extent and rate at which the active drug ingredient is absorbed from a drug product and becomes available at the site of drug action.
15. Drug Metabolism: The process by which the body breaks down and converts medication into active chemical substances.
16. Toxicology: The study of the adverse effects of chemical substances on living organisms.
17. Good Clinical Practice (GCP): An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
18. Regulatory Affairs: The department in a pharmaceutical company that ensures that the company complies with all of the regulations and laws pertaining to their business.