Absorption: the molecules of a drug passing from the site of delivery into the bloodstream.
Adsorption: the ability of a solid or liquid to bind molecules, gas atoms, liquids or solids to its surface.
Active substance: it is the active component of the medicinal product, the one responsible for its healing effect.
Adverse Event: any adverse event of a medical nature occurring in a patient or participating subject during a clinical trial, in which some pharmaceutical product has been administered and which does not have to have any causal relation with such treatment.
An Adverse Event (AE) can therefore be any adverse or unwanted sign (including an abnormal laboratory result), symptom or condition associated with the use of the medicinal product (during the trial) occurring at the same time, even if not necessarily related to the medicinal product (during the trial).
Adverse Reaction: (ADR) During the clinical trial of a new medicinal product, before it is approved or if it is applied to new uses, just because its therapeutic dosage cannot be determined: any unfavourable or unwanted reaction to a medicinal product associated to any dosage must be considered an adverse reaction of a drug. “Reactions to a medicinal product” mean that there is at least a reasonable likelihood of a causal relation between a medicinal product and an adverse event, i.e. that such relation cannot be ruled out. As to those medicinal products that are already commercially available: an unfavourable, unwanted reaction to a drug occurring with doses that are normally used in man for the prophylaxis or treatment of a disease or to alter a physiological function.
Agammaglobulinaemia: (Bruton’s disease or X-recessive agammaglobulinaemia): an hereditary alteration of the immune system, causing a quantitative and functional deficiency of immunoglobulins (antibodies); people affected by such condition suffer from infections all the time.
AIC (Autorizzazione all’Immissione in Commercio = Marketing Authorisation): an official document issued by the pharmaceutical regulatory authority (the Health Ministry in Italy) to freely sell or distribute a medicinal product after such product has been tested for safety, effectiveness and quality.
Albumin: a plasma protein produced by the liver. It decisively contributes to maintaining the oncotic pressure of the plasma; it is the most important circulating protein and can bind and carry many substances, including hormones, xenobiotics, fat acids and bilirubin. Serum albumin levels range between 3.5 and 5.5 grams per 100 millilitres. Relative increases (hyperalbuminaemia) are caused by dehydration, while a decrease may be due to malnutrition, malabsorption syndrome, hyperthyroidism, eclampsia, liver disorders or to an excessive loss, as in the case of oedema, ascites, burns and nephrotic syndromes. Hypoalbuminaemia (a decrease in serum albumin levels) induces oedema and peritoneal, pleural or pericardial effusions.
Antibodies: they are Y-shaped proteins synthesised by the cells of the immune system (lymphocytes B), which are used by the organism to neutralise pathogens (such as viruses or bacteria), which are recognised by their containing specific antigens on the surface.
Antigen: a foreign substance that induces an immune response, boosting the production of antibodies. Antigens enable our organism to recognise and neutralise pathogens such as viruses or bacteria.

Bacteria: micro-organisms composed of one single cell, the size of which ranges between 0.2 and 10 micrometres. They are externally coated in a cellular wall and have no real nucleus. In man, bacteria are the cause of many diseases, from simple tooth decay to far more serious conditions, such as tetanus.  
Bioavailability: the fraction of the dose of the drug which reaches the systemic circulation.
Bioequivalence: it means that the pharmacological and clinical specifications of two drugs, which are therapeutically identical, are perfectly equivalent.
Biological products: end products for human or veterinary use, manufactured in compliance with the provisions laid down by the Authorities.
Blood: blood is a fluid tissue, which flows in the blood vessels (arteries, veins, capillaries). It is composed of a solid or corpuscular part, which is made up by the circulating cells (red blood cells, white blood cells, platelets), and of a fluid part, the plasma. The blood carries oxygen and nourishment to the tissues.
Bottle: a glass container containing one or more doses of a medicinal product. The bottle is isolated from the external environment by a rubber stopper, which keeps the medicinal product sterile.

Cell: it is the basic unit of life of all living beings (except viruses, whose nature as living organisms is still under discussion). Every cell has a specific task (such as, for instance, acting as a reservoir of energy resources –fat cells – or as a carrier of nervous impulses – neurons) which enables the whole organism to properly function.
Centrifuge: a laboratory appliance, which uses centrifugal force, usually to separate parts of fluids with different specific gravities or different densities. As well as being used for separation, it is also an extremely efficient and effective means to make samples dry or solvents evaporate.
Certification: the deed through which an independent third party (a certification body) certifies that a given product, process or service complies with the requirements of a regulation or any other regulatory deed.
Coagulation Factors: the coagulation factors are plasma proteins, mostly produced by the liver, often labelled with Roman numerals in the order in which they have been discovered, which contribute to blood coagulation. There are two coagulation mechanisms:

• Intrinsic: occurring every time the blood comes into contract with a surface other than the blood vessels (vascular endothelium). This coagulation mechanism is mediated by factors Xll, Xl, lX, and Vlll;
• Extrinsic: mediated by factors Vll, X, V and caused by the release of substances from damaged cells (phospholipids and tissue factor or tissue thromboplastin).

Compliance: this word means the patient’s total adherence to the therapy and medical prescriptions. It is essential to respect the prescribed dosage, times and routes of administration to achieve the best therapeutic result. Between 30% and 50% of patients fail to adhere to the prescribed dosage, thus risking to thwart the therapeutic effect of the treatment.

Dear Doctor Letter: a letter directly addressed to doctors which may be sent by mail, in which the Health Ministry sends useful information for a timely update on the use of drugs and potential adverse reactions.
Distribution: the molecules of the drug passing from the bloodstream into the tissues.
Dosage: the amount or dose of active substance which is contained in a posologic unit, i.e. in a vial, bottle, tablet, capsule, sachet, etc.

Electrophoresis: a separation technique based on the mobility of the molecules under the influence of an electric field. This method is used to carry out the so-called proteidogram or electrophoresis of the serum proteins, a laboratory test that is used to observe relative concentrations of the protein components of the serum (such as albumin and a,b,g globulins).
Excipient: it is a component with no biological activity, which is contained in the medicinal product. Usually every medicinal product contains at least one excipient. These substances, such as starch, cellulose, talc, magnesium stearate, glycol propylene, water, saccharose, serve some essential technical functions: they protect the active substance from external aggressions (heat, cold, humidity, chemicals); increase its volume (100-500 milligrams of active substance are a microscopic amount), so that acceptable volumes of solutions can be prepared; stabilise solutions and suspensions, preventing the active substance settling on the bottom of the container; promote the absorption of the active substance; correct the unpleasant taste of most medicinal products.

Filter: a filtering device composed of a filtering substance and a medium, which lets the fluid pass through, while trapping any corpuscular particles contained in the fluid.
Filtrate: a solution resulting from a filtration process.
Filtration: a separation technique whereby any particle contained in a fluid is removed by passing through a permeable material.

GCP (Good Clinical Practice): a reference standard for the design, conduction, performance, monitoring, check, registration of tests and reports on clinical studies, which ensures the reported data and results are reliable and accurate, and that the rights, integrity, privacy and well-being of the participating subjects are protected.
Generic drug: this means an unpatented medicinal product. The molecular structure of the active substance or the composition, which have been disclosed once patent rights have expired, are “publicly accessible”, “generic”. Any pharmaceutical company can copy and market the drug after obtaining a Marketing Authorisation (AIC) from the Health Ministry.
GMP (Good Manufacturing Practice): an international reference standard which guarantees the consistency, effectiveness, safety and quality of a productive process; every pharmaceutical company implements its own activities in strict compliance with such regulatory provisions.

Haemophilia: it is an hereditary disease caused by the lack of some coagulation factors which are needed for normal haemostasis of blood. Two types of haemophilia are known: haemophilia A, caused by a quantitative and/or qualitative deficiency of factor VIII, and haemophilia B, also known as Christmas disease, caused by a quantitative and/or qualitative deficiency of factor IX.
Health: the World Health Organisation defines health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity" and states that: “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being”. Health is a right. The right to health is recognised by the Italian Constitution as a fundamental right (art. 32).

Immunoglobulins (Ig): also known as antibodies, they are a group of proteins contained in blood and tissues. They are produced by the cells of the immune system (lymphocytes B) at the stage of their terminal differentiation or by plasma cells, following contact with foreign substances (antigens).
Infection: a pathological condition caused by different classes of organisms (viruses, bacteria, fungi, protozoa) invading the tissues. Such condition is the result of an interaction between the parasitic organism and the immune response of the host organism. An infection can occur without symptoms (asymptomatic) or with specific symptoms (symptomatic). Examples of infections include: athlete’s foot (an infection caused by fungi of the genus Trichophyton), malaria (caused by the protozoan Plasmodium falciparum), influenza (caused by the influenza virus) and cystitis (caused by the bacterium Escherichia coli).
Inspection by the Authorities: a regular inspection by the authorities concerned (for example: the Health Ministry), conducted by industry experts (for example: the Italian National Health Institute), of pharmaceutical companies to check their work and whether they comply with the applicable regulatory provisions, such as GCP and GMP.

Leaflet: it is the medicinal product’s ID card; it must contain everything the patient needs to know about the medicinal product: therapeutic indications, dosage, precautions, contraindications, interactions with other medicinal products, side effects, special notices, etc.
Lyophilisation: a controlled dehydration process. This method includes two physical processes: freezing and sublimation. In the first stage, the product is quickly frozen, then it undergoes a vacuum treatment to sublimate the micro-crystals of frozen water, the result of which is a drug in the form of a lyophilised powder which offers several advantages: the drug can be stored for a longer time without altering its original specifications, the drug is protected from micro-organisms.

Medicinal product: any substance or composition which is presented as having healing or prophylactic properties for man, as well as any substance or composition to be administered to man in order to establish a medical diagnosis or to reinstate, correct or alter a physiological function in man. It is composed of active and inactive components, such as excipients.
Micrometre (mm): the thousandth part of a millimetre.

NAT: a nucleic acid amplification technique (Nucleic Amplification Test); a test procedure, which is used to search for and find specific nucleotide sequences which are suggestive of bacterial or viral contamination.
Non-fibre-releasing filter: a properly-treated filter which releases no fibres into the filtrate.

Official Pharmacopoeia: the complete collection of all drugs and excipients which are admitted in Italy, setting out legally-binding prescriptions. It includes monographs on pharmaceutical substances and preparations, which outline their specifications and purity, harmlessness and activity tests. In addition to the Italian Pharmacopoeia, a similar European Pharmacopoeia exists and is equally binding in Italy.
Oncotic pressure: the osmotic pressure applied by proteins circulating in the bloodstream (usually albumin). In other words, oncotic pressure is equivalent to the force of attraction that the proteins (or any other type of molecule which can apply such pressure, named colloids) have for fluids. The oncotic pressure of plasma is approximately 20-25 mmHg: under normal conditions, a state of equilibrium is maintained which causes water to be shared between the plasma and the interstitial space (i.e. any space outside the vessels and cells). Any condition resulting in a decrease in circulating albumin (hypoalbuminaemia) would make the plasma unable to convey the water, which would build up outside the vessels, thus causing oedemas.
Osmotic pressure: osmotic pressure is a colligative property of solutions. Osmotic pressure develops whenever two solutions having a different concentration are in mutual contact but separated by a semi-permeable membrane which lets the solvent pass, but traps out the solute.

Pasteurisation: a process whereby a food or other substance is heated for a controlled time and at a controlled temperature to inactivate any pathogen it may contain, without damaging the substance.
Patent: when they discover a new active substance or a new pharmaceutical composition, pharmaceutical companies legally register a patent for such discovery, to secure for themselves the possibility to use it on an exclusive basis for a given number of years.
Pharmaceutical form: it is the macroscopic appearance of a medicinal product. Pharmaceutical forms include tablets, capsules, pills, syrups, powders (packaged in bottles or sachets), solutions (drops, eye-drops, vials for injections or aerosols).
Pharmacovigilance: it is the control of any adverse reactions observed during the administration of a medicinal product. Such adverse reactions are reported to the central and local health authorities (in Italy they are the Health Ministry, the Regions and the Local Health Units) so that they can review such data and take measures as needed, including: changing the indications written on the leaflet of the medicinal product, changing the doses, excluding or including some categories of patients (elderly, children, at-risk patients, etc).
Placebo: every treatment that is deliberately used but which has no specific pharmacological effect. Placebo products are used for the treatment of psychosomatic conditions (i.e. conditions that have no organic causes) or to test a drug for effectiveness during a clinical trial. By comparing the effect of the placebo with the effect of the product being tested, one can find out whether the latter has a real pharmacological effect or not.
Posology: the number of doses the patient has to take in 24 hours to obtain a therapeutic effect.
Prescription drugs: also known as ethical drugs or life-saving drugs, these drugs can be bought or obtained only by producing a medical prescription.
Primary package of a drug: a container (a bottle, blister pack, vial or any other form of package) which is directly in contact with the medicinal product.

Quality Assurance: a regular, recurring and independent preventative process for ensuring that an activity will be designed, developed, conducted and documented according to the applicable industry requirements.
Quality Control: a group of techniques and operating methods which are designed to monitor and test the quality standard of a given system/activity.  

Registered Trademark: it is the name the pharmaceutical company chooses for its medicinal product and is accompanied by the symbol: ®. It is registered to prevent any other company using the same name to market or sell a different medicinal product.
Route of administration: the route used to administer a drug, which can be: enteral (oral, sublingual and rectal), parenteral (intramuscular, intravenous), pulmonary, ocular, vaginal and transepidermal.

SPC: Summary of Product Characteristics: it contains all that is known and that the doctor must know about a medicinal product: indications, doses, contraindications, interactions with other drugs, side effects, etc. It is one of the most important documents of a medicinal product: it is regularly updated and it is authorised by the Health Ministry. It is accessible to doctors only.
Sterile: a product or system that undergoes a sterilisation process and in which every form of life has been destroyed.
Sterilising filter: a special type of filter, with a pore size of less than 0.2 mm, which traps any micro-organisms (which can be proven by control tests, as described in the Pharmacopoeia).
Sterilizer: an appliance or system (autoclave, stove, etc.) which destroys every form of life in a product.
Storage: all drugs must be always stored in their original packages, along with their leaflets and as prescribed therein.

Tangential flow filtration: a filtration process, which extends the average life of filters. It consists in using a fluid-delivery flow, which tangentially brushes the filtering surface, so as to dislodge any particle settling on to the filter.
Temperature (drug storage temperature): temperature is a key factor in the storage of a drug. The storage temperature written on the package must be abided by. The effect of temperature on the drug builds over time until the active substance completely deteriorates.

Use-by date: on a drug, the use-by date is the time by which the drug must be used. Before such date, the drug, if stored as specifically described, retains its physical and chemical, pharmacological and therapeutic specifications.

Vaccine: a vaccine is a properly-treated preparation, containing material composed of micro-organisms or parts of micro-organisms, so as to retain their immunogenic effect. Immunity is the result of the vaccine stimulating the recipient to produce antibodies, which neutralise the antigen contained in the vaccine and, as a consequence, the micro-organism itself. Its basic requirements are: harmlessness, effectiveness, easy administration, low production costs.
Validation: a documented assessment aimed at ensuring that a given process, conducted within some set parameters, will consistently produce the specifications and quality standards that have been determined by the authorities concerned.
Vial: a glass container which contains a medicinal product in the form of a solution or dry powder or crystalline powder, to be reconstituted with the addition of a specific solvent, and which protects the medicinal product until it is administered.
Viral inactivation/removal: chemical or physical processes approved by international health authorities, aimed at reducing the likelihood of transmitting viral pathogens through the biopharmaceutical products without altering their beneficial effects.
Virus: virus is the Latin for poison. Viruses are biological entities which can infect the cellular organisms, whose nature as living organisms is under discussion. Viruses are all obligate endocellular parasites (i.e. they must enter the cell to be able to act). Viruses bear a protein coating called capsid and sometimes an external membrane (pericapsid) which surrounds the viral capsid.