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Glossary

Morbidity Rate
The rate of illness in a population, i.e. the number of people ill during a time peirod divided by the number of people in the total population.
Mortality Rate
The rate of death in a population, i.e. the number of people who die during a time period divided by the number of people in the total population (or the number of people exposed).
Off-Label Use
An approved drug prescribed for conditions other than those approved by the regulatory authorities.
Open-Label Study
A study in which everyone is informed of the drug and dose being administered.
Orphan Drug
A regulatory agency category that refers to medications used to treat diseases and conditions that occur rarely.
Pharmacoeconomics
The study of costs and benefits of drugs, both financial and quality of life.
Pharmacogenetics
The study of how different groups of people respond to drugs, based on their genetic makeup.
Pharmacokinetics
The study of how drugs are used and changed in the body; for example, absorption, distribution, metabolism, and excretion of a drug or vaccine.
Phase I
Phase I studies are the first studies of an experimental drug. They are usually conducted in healthy human volunteers. These studies collect information on the tolerability, pharmacokinetics and side effects of the drugs. They do not treat disease or illness.
Phase II
Phase II studies evaluate the safety and effectiveness of an experimental drug. These studies are conducted in patients with a specific disease or medical condition.
Phase III
Phase III studies compare the safety and efficacy of a new experimental treatment against existing therapies. These studies are conducted in a large number of patients with a specific disease or condition.
Phase IV
Phase IV studies are performed after regulatory authorities approval of the drug. These studies are conducted to further understand the safety of the drug in groups of patients with a specific disease or condition. They are also used to secure approval for new indications.
Placebo
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos. When a placebo is used, neither the patient nor the doctor knows what treatment the patient is receiving.
Preclinical Phase
Laboratory or animal studies conducted prior to use of the experimental drug in people.
Prevalence
The total number of people infected or having a disease in a specific population at a particular time.
Principal Investigator
see Investigator