M. Karch - Chapter 1
Adverse Effects - ANSThe undesired, unpleasant, or even dangerous results some drugs
produce.
Brand Name - ANSThe name given to a drug by the pharmaceutical company that
developed it.
Chemical Name - ANSThe name that reflects the chemical structure of a drug.
Drugs - ANSChemicals that are introduced into the body to bring about some sort of change.
Federal Drug Administration (FDA) - ANSThe federal agency responsible for drug regulation,
enforcement, evaluation, and distribution policies.
Generic Drugs - ANSDrugs sold by their chemical name rather than the brand (trade) name.
Generic Name - ANSThe name given when the drug company that develops it applies for
the approval process.
Genetic Engineering - ANSThe process of altering DNA, usually of bacteria, to produce a
chemical to be used as a drug.
Orphan Drugs - ANSDrugs that have been discovered but would not be profitable for a drug
company to develop; usually drugs that would treat only a small number of people; these
orphans can be adopted by drug companies to be developed.
Over the Counter (OTC) - ANSDrugs available without a prescription for self treatment of a
variety of complaints and deemed to be safe if used as directed.
Pharmacology - ANSThe study of the biological effects of chemicals.
Pharmacotherapeutics - ANSThe branch of pharmacology that deals with drugs and
chemicals for use in medicine for the treatment, prevention and diagnosis of disease in
humans (aka, clinical pharmacology).
Phase One Study - ANSA pilot study of a potential drug done with a small number of
selected healthy human volunteers.
Phase Two Study - ANSA clinical study of a proposed drug by selected physicians using
actual patients who have the disorder the drug for which the drug is designed to treat and for
which patients must provide informed consent.