Glossary

Animal Drug User Fee Act of 2003

Adenovirus

Advanced Medical Technology Association

A structure arising at sites other than the usual ones, e.g., shoots from roots or leaves, and embryos from any cell other than a zygote.

Acquired, sporadic, accidental contaminants in a cell line, such as viruses and toxins; often infectious agents.

(ICH Q5A (R1)) Unintentionally introduced contaminant viruses.

Undesired effects or toxicity due to exposure (often but not limited to a drug or medical device).

Any undesirable experience associated with the use of a medicine in a patient. Adverse events can range from mild to severe. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects.

An unintended reaction to a drug taken at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. In clinical trials, an ADR would include any injuries by overdosing, abuse/dependence, and unintended interactions with other medicinal products.

An undesirable effect that may be caused by a study drug.

An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy).

An undesirable health event that occurs in a participant during a clinical trial. It may or may not be related to the treatment itself.

Report to appropriate institutional officials about adverse events.

AERS is a computerized database containing reports of adverse events. It supports FDA’s post-market safety surveillance program for all approved drugs and therapeutic biologics.

Undesired effects or toxicity in a patient due to exposure (often to a drug or medical device, but not limited to those). Adverse events must be notified to the sponsor, who is required to perform a written investigation into the root causes, and may need to take other corrective or preventive actions.

A change in body function or cell structure that might lead to disease or health problems.

An alarm indicating a drift of a monitored parameter toward an out-of-spec condition. It is advisory in that no GMP violation has occurred, and is used to advise corrective action before an action alarm can happen.

Adverse Event

Anti-Epileptic Drug

Adverse Event Report

To supply with or mix with air or gas. The process is aeration.

An organism that can live and grow only in the presence of oxygen.1.Facultative aerobe: one which normally thrives in the absence of oxygen, but which may acquire the faculty of living in the presence of oxygen.2.Obligate aerobe: one that cannot live without air.

The plural of aerobe.

Growing in the presence of oxygen. An obligate/strict aerobe grows only under such a condition.

Living in air or requiring oxygen.