Key terms
Abbreviated new drug application
the process by which applicants must scientifically demonstrate to the FDA that their generic product is bioequivalent to or performs similarly to the innovator drug
Antigen
a foreign substance or toxin introduced into the body that stimulates an immune response
Bactericidal agent
a drug that kills bacteria
Deoxyribonucleic acid (DNA)
the helix-shaped molecule that carries genetic code
gr
grain
Active ingredient
the biochemically active component of the drug that extents a desired therapeutic affect
Antineoplastic drug
a cancer-fighting drug
Bioavailability
the time it takes for a generic drug to reach the bloodstream after administration
Destructive agent
a drug that kills bacteria, fungi. Viruses, or even normal or cancer calls
FXD
for 10 days
Adverse drug reaction (ADR)
an unexpected negative consequence from taking a particular drug
Antiseptic
a substance that kills or inhibits the growth of microorganisms on the outside of the body to reduce the possibility of infection, sepsis, or putrefaction
Bioequivalent
a drug that delivers approximately the same amount of active ingredient into healthy volunteer-s bloodstream in the same amount of time as the innovator or brand name drug
Diagnostic agent-
a drug that helps a provider determine the correct diagnosis, such as one containing tracer radioactive isotopes or dyes used to help visualize problems
h
hour
Adverse Event Reporting System (AERS
a post-surveillance centralized database maintained by the FDA for all reported adverse events from drugs and vaccines
Antiviral drug
a drug that kills viruses, such as HIV
Biogentically engineered drugs
substances derived from the sciences of biology, chemistry, immunology, and generic engineering to produce specific therapeutic effects
Dietary supplement
a category of nonprescription drugs, which includes vitamins, minerals, and herbs, that is not regulated by the FDA
h.s.
at bedtime
Antibodies
the part of the immune system that neutralizes antigens or foreign substances in the body
Aseptic technique
the manipulation of sterile products and devices to avoid contamination by disease-causing organisms; includes clean room protocols and
Biotechnology
the field of study that combines the sciences of biology, chemistry, and immunology to produce synthetic, unique drugs with specific therapeutic effects
Drug
a medicinal substance or remedy used to change the way a living organism functions; also called medication
IN
internasal