Glossary

An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.

A valued or desired outcome; an advantage.

Documentation as to how the project benefits of a project will be measured in order to demonstrate the business case has been achieved.

Business Executives for National Security

Bioequivalence

Blood Establishment Registration and Product Listing (CBER)

A system produced for a customer, specifically to order, to meet a defined set of user requirements. Also called Custom Built System.

Biomonitoring of Environmental Status and Trends Program (United States Geological Survey)

Bacterial Endotoxins Test

Acceptance testing performed by the customer in a live application of the software, at one or more end user sites, in an environment not controlled by the developer.

For medical device software such use may require an Investigational Device Exemption (IDE) or Institutional Review Board (IRB) approval.

Penicillins, cephalosporins, monobactams, and carbapenems. Other APIs containing beta-lactam rings; beta-lactamase inhibitors,clavulanic acid, and sulbactam and tazobactam; typically with sensitization potential.

Bovine Enterovirus

Vaculovirus Expression Vector System

Biologics Field Advisory Committee (CBER)

Bureau of Food & Drug Administration (Philippines)

Bundesinstitut fur Arzneimittel und Medizinprodukte (German Ministry of Health)

Blow/Fill/Seal processing

Budesgesundheitsamt (German Federal Health Office)

Institute für Arzneimittel des Bundergesungdheitsamtes (German Health Authority)

Bovine Growth Hormone

Buffalo Green Monkey

British Generic Manufacturer’s Association

Baby Hamster Kidney cells