Glossary

A structural, functional, or metabolic abnormality present at birth that results in physical or mental disability or is fatal. There are more than 4,000 known birth defects, which may be caused by genetic or environmental factors. About 150,000 babies are born each year with birth defects.

Biomedical Information Science and Technology Initiative (NIH)

Biomedical Information Science and Technology Initiative Consortium (NIH)

A contraction of the term binary digit. The bit is the basic unit of digital data. It may be in one of two states, logic 1 or logic 0. It may be thought of as a switch which is either on or off. Bits are usually combined into computer words of various sizes, such as the byte.

A measure of the speed of data transfer in a communications system.

Bovine Immunodeficiency Virus

Body Image Visual Analog Scale

Biosafety Level

Biosafety Laboratory

Biologics License Application

The required application for marketing a biologic product in the United States. Most biopharmaceuticals are biologics.

A preliminary analysis omitting only the sample to provide an unbiased reference point or baseline for comparison. It is important to minimize extraneous contamination that could be confused with constituents in the sample itself.

Blanketing is the term used to describe putting a layer of gas, typically nitrogen into the space in a vessel above the product generally with the intention of preventing oxygen in the air contacting and degrading the product, though it may also be used to maintain a low oxygen atmosphere to reduce risks ox explosion.

A preimplantation embryo of about 150 cells. The blastocyst consists of a sphere made up of an outer layer of cells (the trophectoderm), a fluid-filled cavity (the blastocoel), and a cluster of cells on the interior (the inner cell mass).

Any one of the cells formed from the first few cleavages in animal embryology. The embryo usually divides into two, then four, then eight blastomeres, and so on.

A fluid, powder or other whitening (bleaching) or cleaning agent, usually with free chlorine ions. Commercial bleach contains calcium hypochlorite or sodium hypochlorite, and is a common disinfectant used for cleaning working surfaces, tools and plant materials in plant tissue culture and grafting.

A randomized trial is “Blindâ€? if the participant is not told which arm of the trial they are on. A clinical trial is “Blindâ€? if participants are unaware of whether they are in the experimental or control arm of the study; also called “Maskedâ€?. • Phase I Clinical Trial • Phase II Clinical Trial • Phase III Clinical trial • Phase IV Clinical Trial

Study where the test article and the reference standard are blinded (look alike) an provided in uniquely identified containers (e.g., subject specific, unit doses or IVR) with a randomization code assigned. Supplies may be randomized in”blocks” where a statistical ratio of test article to reference standard has been allocated. In these cases, random selection should be in block sizes in sufficient quantity to meet the retention sample requirements.

A weld joint by design that cannot feasibly be visually inspected internally.

A method used in a clinical trial to prevent participants and/or researchers from knowing whether the patient is receiving the experimental or control treatment in a trial. Also referred to as “masking.” Single blinding is when only the patient does not know which treatment he or she is receiving.

Clinical trial technique in which, to eliminate bias in a research study, subjects and/or clinical investigators remain unaware of which investigational product is provided.

A procedure in which one or more patients to the clinical trial (i.e., the subject/patient, investigator, and/or sponsor medical personnel) are kept unaware of the treatment assignment(s) of the clinical trial participants. Used to remove potential for study bias

The process by which the physical appearance of a comparative agent (or other drug product) is altered to obscure the identity of the drug product. Often obscured in such a way as to look like other products.