Write the definition of
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.
Abbreviated New Drug Application:
a cancer-fighting drug.
Antineoplastic drug
a drug that kills bacteria
Bactericidal agent
an inactive chemical—such as a filler, preservative, coloring, or flavoring—that is added to one or more active ingredients to improve drug formulations while causing little or no physiological effect; also called an inactive ingredient
Inert ingredient
What does ou mean?
both eyes
the biochemically active component of the drug that exerts a desired therapeutic effect.
Active Ingredient
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.
Antiseptic
the time it takes for a generic drug to reach the bloodstream after administration
Bioavailability
a document that states, in easily understandable terms, the purpose and risks of a drug research that human volunteers can take part in
Informed consent form
What does lb mean?
pound
an unexpected negative consequence from taking a particular drug.
Adverse Drug Reaction (ADR)
a drug that kills viruses, such as HIV
Antiviral drug
a drug that delivers approximately the same amount of active ingredient into a healthy person’s bloodstream in the same amount of time as the innovator or brand name drug
Bioequivalent drug
National number assigned to any brand name or generic drug; also identifies the manufacturer, drug, and packaging size
NDC
What does cm mean?
centimeter
a post-surveillance centralized database maintained by the FDA for all reported adverse events from drugs and vaccines.
Adverse Event Reporting System (AERS)
a drug that kills viruses, such as HIV
Antiviral drug
a medicinal substance or remedy used to change the way a living organism functions; also called a medication
Drug
a drug substance that alters body functions in a desired way
Pharmacodynamic agent
What does aq mean?
water
the part of the immune system that neutralizes antigens or foreign substances in the body.
Antibodies
the manipulation of sterile products and devices to avoid contamination by disease-causing organisms; includes clean room protocols and hand-washing and gowning procedures
Aseptic technique
the ability of the body to resist a specific disease
immunity
a field of study that examines the relationship between an individual’s genes and his or her body’s response to drugs
Pharmacogenomics
What does po mean?
by mouth