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a
ADR
Adverse Drug Reaction: A response to a drug that is noxious and unintended.
ATC
Anatomic, therapeutic, chemical. The international system for classification of medicines.
b
Biotechnology
Biotechnology describes the traditional biological methods which living organisms use to produce or modify chemical compounds (eg, antibiotics and vitamins). Secondly, it includes gene technology, which is based on the ability to isolate, replicate, cut and recombine DNA and to transfer DNA from one cell to another. Organisms whose genetic material has been altered in a way that does not occur naturally are called genetically modified organisms (GMOs).
Benchmarking
Benchmarking is the search for industry best practices that will lead to superior performance.
Blockbuster
Refers to a drug that amasses more than US$1 billion in global sales.
c
Cell
The cell is the basic unit of all living organisms. Some living organisms exist only as a single cell. This is the case for bacteria, as well as certain animals and plants. An average-sized man contains from 60 to 100 trillion cells. Cells nourish themselves, produce energy, exchange information with their neighbours, multiply, and eventually die when their time has come.
Clinical trials
A clinical trial is a research study conducted on humans to assess the safety and efficacy of a medicine. Clinical trials on new medicines and sponsored by pharmaceutical companies can only be started after a compound has survived thorough pre-clinical development work, which involves laboratory testing.
CRO (Clinical Research Organisation)
An organisation that provides services to the pharmaceutical industry and specialises in the conduct of clinical trials.
d
Differential pricing
When prices are adapted to the purchasing power of the world's poorest countries. (Sometimes referred to as 'tiered pricing', 'equity pricing' or 'preferential pricing').
Disease
An alteration in the state of the body or of some of its organs, interrupting or disturbing the performance of the vital functions.
DTCI – Direct-to-consumer Information
The pharmaceutical industry considers that all patients should have the same right to truthful, accurate and easily understandable information that enables them, in consultation with their doctors, to make well-informed choices about their health.
g
Generic
An off-patent medicine. Until the patent expires, only the company that discovered a new medicine may produce it. After patent expiry, any company may produce the same generic compound.
Genes
Genes are formed from DNA, carried on the chromosomes and are responsible for the inherited characteristics that distinguish one individual from another. Each human individual has an estimated 100,000 separate genes. More generally, the term 'gene' may be used in relation to the transmission and inheritance of particular identifiable traits.
Gene therapy
The replacement of a defective gene in an organism suffering from a genetic disease. Recombinant DNA techniques are used to isolate the functioning gene and insert it into cells. Over 300 single-gene genetic disorders have been identified in humans. A significant percentage of these may be amenable to gene therapy.
i
Incidence
The number of new patients affected by the disease per annum.
Informed consent
The concept of informed consent (required to participate in clinical trials) is based on the principle that a physician/doctor has the duty to disclose information to a patient (eg, potential risks, benefits and alternatives) that allows the patient to make reasonable decision regarding his or her participation in a clinical study.
Innovation
Technological progress that leads to the creation of an entirely new product (product innovation), or a reduction in the cost of producing (process innovation), or an increase in the therapeutic value of an existing product for patients. Innovations can lead to new active substances, new indications for existing products or new ways of administering the same product.
m
Medicinal product
Under EU law, a medicinal product is defined as any substance or combination of substances presented for treating or preventing diseases in human beings or animals. Any substance or combination of substances that may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.
o
OTC (Over the counter)
A medicine available without a prescription.
Outpatient care
Medical services that are provided without the need for an overnight stay in a hospital, such as through an ambulatory-care clinic or emergency department.
Orphan drug
A drug that only has a limited target population or that treats a rare disease, thus limiting its commercial and financial potential.
p
Parallel trade
Parallel trade is the purchase of goods at low prices in one country and the subsequent resale of those goods at higher prices in another country.
Patent
A patent is a legal, public document granting an intellectual property right to the patent holder. At the same time the information relating to the invention is made public, thereby enhancing the public good and protecting the rights of the inventor. In exchange for publication of his or her patent, the inventor is rewarded a limited monopoly allowing the patent holder to prevent others from making, using or selling the patented product. The monopoly is limited as to time (now 20 years from the date of filing of the patent application) and by national boundaries (where the patent has been granted). Patents for inventions are granted only if three conditions are met: novelty, industrial applicability and inventive step.
Pharmacogenomics
The process of identifying differences in genetic sequences between individuals, and developing therapies accordingly.
Pharmacology
Pharmacology is a broad discipline encompassing all aspects of the study of drugs, including their discovery, development and actions.
Pharmacovigilance
Refers to the careful monitoring and continuous surveillance of the safety of an authorised medicinal product during its life on the market.
PIL – Patient Information Leaflet
Provides a set of information, in a particular order, accompanying each medicine. It is usually the only source of information on how to use a medicine safely and effectively, when the patient actually takes the medicine.
Primary care
Primary care is first contact, continuous, comprehensive and co-ordinated care provided to individuals and population undifferentiated by age, gender, disease or organ system.
r
Rx
Prescription medicine (in the US).
s
Stem cell
Stem cells are unspecialised 'master' cells that differ from other kinds of cells in the human body in that they have a unique capacity to multiply and differentiate into many types of specialised cells and tissues. Stem cells exist at all stages of human development from early embryos, to foetuses, to adults. There are three types of stem cells: embryonic, foetal and adult. While the use of adult stem cells is well accepted and non-controversial, research into embryonic and foetal stem cells raises a number of ethical questions.
v
Vaccine
Refers to the introduction of vaccine into the body for the purpose of inducing protective immunity against infectious diseases. Conventional prophylactic vaccines aim at stopping people becoming infected. Therapeutic vaccines are products that stimulate the immune system of people with chronic infection to eliminate the virus from their bodies. Vaccine preparations can be natural, synthetic or derived by recombinant DNA technology.
Virus
A microorganism smaller than bacteria, which cannot grow or reproduce apart from a living cell. A virus invades living cells and uses their chemical machinery to keep itself alive and to replicate itself.
w
WHO (World Health Organisation)
Founded in 1948 with headquarters based in Geneva, the World Health Organisation is a specialised agency of the United Nations with 191 Member States, which promotes technical co-operation for health among nations, carries out programmes to control and eradicate disease and strives to improve the quality of human life.
WTO (World Trade Organisation)
Established since 1 January 1995 in Geneva, the World Trade Organisation (WTO), with a membership of 145 countries, is the only global international organisation dealing with the rules of trade between nations. The goal is to help producers of goods and services, exporters and importers conduct their business.
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