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edited by AIFA’s Office of Osmed and HTA

Glossary

b
BATCH (LOT)
A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval. [Source: EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use]
BENCHMARK
A measure or standard to which an activity, performance, service or result can be compared. Benchmarking is the term given to the process of measuring standards of actual performance against those achieved by others with broadly similar characteristics. The aim is to improve quality so that all organisations or services can raise their own performance to that of the best. [Source: NICE Glossary]
BIOAVAILABILITY
Bioavailability means the rate and extent to which the active substance or active moiety is absorbed from a pharmaceutical form and becomes available at the site of action. In the majority of cases substances are intended to exhibit a systematic therapeutic effect, and a more practical definition can then be given, taking into consideration that the substance in the general circulation is in exchange with the substance at the site of action: Bioavailability is understood to be the extent and the rate to which a substance or its active moiety is delivered from a pharmaceutical form and becomes available in the general circulation. It may be useful to distinguish between the absolute bioavailability of a given dosage form as compared with that (100%) following intravenous administration (e.g. oral solution vs. iv.). and the relative bioavailability as compared with another form administered by the same or another non intravenous route (e.g. tablets vs. oral solution). [Source: EMEA. Note for guidance on the investigation on bioavailability and bioequivalence]
BIOAVAILABILITY
Bioavailability means the rate and extent to which the active substance or active moiety is absorbed from a pharmaceutical form and becomes available at the site of action. In the majority of cases substances are intended to exhibit a systematic therapeutic effect, and a more practical definition can then be given, taking into consideration that the substance in the general circulation is in exchange with the substance at the site of action: Bioavailability is understood to be the extent and the rate to which a substance or its active moiety is delivered from a pharmaceutical form and becomes available in the general circulation. It may be useful to distinguish between the absolute bioavailability of a given dosage form as compared with that (100%) following intravenous administration (e.g. oral solution vs. iv.). and the relative bioavailability as compared with another form administered by the same or another non intravenous route (e.g. tablets vs. oral solution). [Source: EMEA. Note for guidance on the investigation on bioavailability and bioequivalence]
BIOLOGICAL MARKER (BIOMARKER)
A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. Biomarkers may have the greatest value in early efficacy and safety evaluations such as in vitro studies in tissue samples, in vivo studies in animal models, and early-phase clinical trials to establish “proof of concept.” Biomarkers have many other valuable applications in disease detection and monitoring of health status. These applications include the following: • use as a diagnostic tool for the identification of those patients with a disease or abnormal condition (e.g., elevated blood glucose concentration for the diagnosis of diabetes mellitus) • use as a tool for staging of disease (e.g., measurements of carcinoembryonic antigen-125 for various cancers) or classification of the extent of disease (e.g., prostate-specific antigen concentration in blood used to reflect extent of tumour growth and metastasis) • use as an indicator of disease prognosis (e.g., anatomic measurement of tumour shrinkage of certain cancers) • use for prediction and monitoring of clinical response to an intervention (e.g., blood cholesterol concentrations for determination of the risk of heart disease). [Source: Biomarkers Definitions Working Group]
BIOLOGICAL MEDICINAL PRODUCT
A biological medicinal product is a product, the active substance of which is a biological substance. A biological substance is a substance that is produced by or extracted from a biological Source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with the production process and its control. The following shall be considered as biological medicinal products:  immunological medicinal products and medicinal products derived from human blood and human plasma  products developed by means of one of the following biotechnological processes: recombinant DNA technology, controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells, hybridoma and monoclonal antibody methods  advanced therapy medicinal products. [Source: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use]
BLOOD ESTABLISHMENT
Any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion. This does not include hospital blood banks. [Source: Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003]
BRANCH PHARMACY
A branch pharmacy is attached to a pharmacy and is operated under its supervision. The branch pharmacy has its own independent premises and professionally qualified staff. Branch pharmacies may retail the same products as the pharmacy and may also dispense prescription medicines. Branch pharmacies (or a limited number of branch pharmacies) may be allowed even in countries where pharmacy chains are forbidden. [Source: adapted from Association of Danish Pharmacies website]
BRAND NAME (INNOVATOR`S NAME, PROPRIETARY PRODUCT NAME, MEDICINE SPECIALITY PRODUCT NAME, MEDICINAL SPECIALITY PRODUCT NAME)
Name given for marketing purposes to any ready-prepared medicine placed on the market under a special name and in a special pack. A brand name may be a protected trademark.
BUDGET IMPACT
A budget is an estimate of revenue and expenditure for a specified period. Budget impact refers to the total costs that pharmaceutical reimbursement and use entail with respect to one part of the health care system, pharmaceutical care, or to the entire health care system, taking into account the possible reallocation of resources across budgets or sectors of the health care system.
BUDGET IMPACT ANALYSIS (BIA)
Budget Impact Analysis is an essential part of a comprehensive economic assessment of a health care technology and is increasingly required, along with cost-effectiveness analysis (CEA), prior to formulary approval or reimbursement. The purpose of a BIA is to estimate the financial consequences of adoption and diffusion of a new health care intervention within a specific health care setting or system context given inevitable resource constraints. In particular, a BIA predicts how a change in the mix of medicines and other therapies used to treat a particular health condition will impact the trajectory of spending on that condition. Users of BIA include those who manage and plan for health care budgets such as administrators of national or regional health care programs, administrators of private insurance plans, administrators of health care delivery organisations and employers who pay for employee health benefits. BIA should be viewed as complementary to cost-effectiveness analysis (CEA), not as a variant or replacement. Whereas, CEA evaluates the costs and outcomes of alternative technologies over a specified time horizon to estimate their economic efficiency, BIA addresses the financial stream of consequences related to the uptake and diffusion of technologies to assess their affordability. [Source: Report of the ISPOR Task Force on Good Research Practices – Budget Impact Analysis]
BULK PRODUCT
Any product that has completed all processing stages up to, but not including, final packaging. [Source: WHO. Good distribution practices (GDP) for pharmaceutical products]
BUNDLING
Bundling is a marketing strategy that involves offering several products for sale as one combined product. [Source: Developed by PHIS group in the framework of PHIS Hospital Pharma]
BURDEN OF DISEASE
The burden of disease is a measurement of the gap between a population’s current health and the optimal state where all people attain full life expectancy without suffering major ill-health. Burden of disease analysis enables decision makers to identify the most serious health problems facing a population. Loss of health in populations is measured in disability-adjusted life years (DALYs), which is the sum of years of life lost due to premature death and years lived with disability. [Source: WHO. Health Promotion Glossary: new terms]
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