Glossary

Bureau of Health Professionals (HRSA)

Trafic pattern such that materials and personnel may enter and leave through an area.

Brick Institute of America

Bureau of Indian Affairs (United States Department of the Interior)

A measure of how closely the mean value in a series of replicate measurements approaches the true value.

A binding offer, usually expressed in monetary terms to provide specific services within clearly stated requirements.

Building Information Modeling

Bioresearch Monitoring

Biologic IND Management System

The base two number system. Permissible digits are "0" and "1".

An explosive material composed of separate components, each of which is safe for storage and transportation and would not in itself be considered as an explosive.

Biological Investigational New Drug

The ability of molecules to stick to each other because of the exact shape and chemical nature of parts of their surfaces. Many biological molecules bind extremely tightly and specifically to other molecules: enzymes to their substrates; antibodies to their antigens; DNA strands to their complementary strands; and so on. Binding can be characterized by a binding constant or association constant (Ka), or its inverse, the dissociation constant (Kd).

Located left or right from the cover page on the booklet label the area where the pages are held together and adhered to the base label.

Biotechnology Industry Association

A prefix derived from bios and used in scientific words to associate the concept of “living organisms.” Usually written with a hyphen before vowels, for emphasis or in neologisms; otherwise usually without a hyphen.

A protein’s ability to function correctly after it has been delivered to the active site of the body (in vivo).

Dispersed biological agents in a gaseous environment.

A procedure for the assessment of a substance by measuring its effect in living cells or on organisms. Animals have been used extensively in drug research in bio-assays for the pharmacological activity of drugs. However, bio-assays are now usually developed using bacteria or animal or plant cells, as these are usually much easier to handle than whole animals or plants, are cheaper to make and keep, and avoid the ethical problems associated with testing of animals. Sometimes used to detect minute amounts of substances that influence or are essential to growth.

A strategy involved in bioremediation that increases the activity of an organism to break down or metabolize a pollutant. This involves reseeding a waste site with bacteria as they die.

Measure of the true rate and the total amount of drug that reaches the target tissue after administration.

Biostatistics Branch (CFSAN)

The concentration of microbial matter per unit volume. Microbial matter includes viruses, bacteria, yeast, mold, and parts thereof.

(ICH Q7) The level and type (e.g. objectionable or not) of microorganisms that can be present in raw materials, API starting materials, intermediates, or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.

The number of viable contaminating organisms per product unit.