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Vernalis - Bio-pharmaceutical glossary Category: Health and Medicine > pharmaceutical Date & country: 11/12/2007, UK Words: 111

Absorption
The entry of a drug substance into the bloodstream from the site of administration.

Acetyl choline
A neurotransmitter in the central and peripheral nerves. Acetyl choline was the first neurotransmitter to be discovered, first described by Sir Henry Dale and colleagues in the UK in the 1930s.

Active substance
A chemical which has been shown to have pharmacological activity.

Adenosine
A purine neurotransmitter and/or neuromodulator that is found in both the peripheral and central nervous system.

Agonist
A substance which interacts with a receptor to cause a biological response.

Akinesia
A 'lack of movement' which is a symptom of Parkinson's disease.

Analgesic
A substance which reduces or eliminates pain.

Analogue
A compound whose chemical structure is similar to another.

Anorectic
Drugs or other substances which reduce appetite.

Antagonist
A substance which reduces or prevents the effect of an agonist at a receptor site.

Anticholinergics
Substances which block the activity of acetyl choline. These agents are modestly effective in Parkinson's disease.

Axons
The long projections from nerves which transmit electrical impulses to the nerve terminals. Axons are covered in an insulating material (myelin) which is composed of fatty substances and looks white to the naked eye (hence the term white matter).

Bioavailability
A measure of the amount of drug which is absorbed into the body and is available to exert its biological action.

Blind study
A double blind clinical study is one in which neither patient nor the investigator knows which drug is being administered during the study. In a single blind study the investigator but not the patient will know which drug is being taken.

Body Mass Index-BMI
A measure of a person's 'fatness'. This is derived by measuring height and weight as follows: BMI = weight in kg/height in metres2 .

Bradykinesia
Slow movement which is often a problem for Parkinson's disease patients.

Cardiac
Pertaining to the heart.

Cardiovascular
Pertaining to the heart and blood vessels.

Catalyst
A substance that accelerates a chemical change.

Cerebral
Pertaining to the brain.

Cirrhosis
A condition which results from long term liver damage (whether by infection, alcohol, drugs or certain inflammatory diseases) and describes a situation in which the liver becomes scarred and functions poorly. If the damage persists the liver goes on to fail, in which case transplantation is the only option.

Clinical data
Usually refers to information obtained during a clinical trial but could be applied to any information obtained from a patient in the course of treatment or examination.

Clinical study
The administration of a drug to healthy volunteers or patients to assess the safety, tolerability, pharmacokinetics and/or efficacy of that drug.

Clinical trial application
An application made to a regulatory authority to seek approval to conduct a clinical study in patients.

CMC
Chemistry, Manufacturing and Control (CMC) data are the chemical and pharmaceutical data which are included in an IND or an NDA.

CMO
Contract Manufacturing Organisation.

Computational Chemistry
A computer method used to design molecules.

COMT-inhibitors
Drugs which block the metabolic breakdown of dopamine by the enzyme catechol-o-methyl-transference (COMT) also help to relieve symptoms of Parkinson's disease to some extent.

Control
The treatment with which the drug being tested is compared â€` often placebo or a marketed drug.

Coronary artery
The blood vessel which supplies blood to the heart.

Cortisol
A hormone which is essential to a number of processes in the body including energy provision (mobilisation and storgage of glucose), salt balance and the body's responses to stress. The 5-HT1A receptor has a role in the regulation of cortisol levels.

CRO
Contract Research Organisation.

Cross-over study
A clinical study in which subjects receive two or more different medications with a drug-free period between them.

Cytokine
A chemical which acts as a cellular messenger, typically of the immune system.

Cytotoxic
Destructive to cells.

Data sheet
A summary of the information about a drug that is provided to doctors and pharmacists in the UK to enable the drug to be prescribed appropriately. It contains the uses, doses, contraindications, warnings and precautions that must be taken into account.

Dopamine
An amine neurotransmitter. The reduced level of dopamine in the 'substantia nigra' brain region is one of the primary deficits in Parkinson's disease patients.

Dyskinesia
The abnormal movements of the face and body that Parkinson's disease patients suffer when given L-DOPA treatment for a number of years. This is a side effect of treatment rather than a symptom of the disease.

Efficacy
The therapeutic effect of a drug.

Emesis
Vomiting - a common problem when treating cancer patients with chemotherapy or radiotherapy.

Endothelin
Group of peptide hormones produced by the vascular epithelium (walls of the blood vessels). When released it acts directly on the walls of blood vessels to cause vasoconstriction. It is the most potent vasoconstrictor known.

Epidemiology
The study of a disease as it affects groups of people.

FDA
United States Food and Drug Administration.

Formulation
The dosage form of a drug such as tablet, capsule, injection, which is made to deliver the drug substance to the body.

GABA
(Gamma Amino Butyric Acid) - an inhibitory amino acid neurotransmitter in brain and spinal cord.

Genome
The total gene complement of a set of chromosomes.

GLP
Good Laboratory Practice. Set of regulations and guidelines controlling the conduct of pre-clinical studies aimed at ensuring the quality and integrity of data generated during development of a new drug.

Glutamate
An excitatory amino acid neurotransmitter in brain and spinal cord.

GMP
Good Manufacturing Practice. Set of regulations and guidelines controlling the quality of manufacturing operations aimed at ensuring consistency of product quality in order to ensure patient safety.

Grey Matter
Parts of the brain rich in nerve cell bodies, hence appearing grey to the naked eye.

Haemoglobin
The iron-containing protein in red blood cells which transports oxygen.

Haemorrhage
Bleeding from a ruptured blood vessel.

Hyperglycaemia
High blood sugar.

Hypothalamic 5-HT1A receptors
The 5-HT1A receptors that are present in the hypothalamic region of the brain.

Immune Response Modifier
A compound which enhances the body's immune response to combat infectious agents.

Immunosuppressants
Substances which reduce the immune response.

In vitro
Carried out in an artificial system outside the body (literally â€` 'in glass').

In vivo
Carried out in a living biological system, either animals or humans (literally - 'in life').

In-licensing
The transfer of a licence by agreement from another organisation in order to develop or market the particular product which is licensed.

IND
Investigational New Drug. The notification of data relating to a new drug, which must be made to the FDA before it may be administered to man.

Indication
A disease target for a drug.

Interferon
One of a number of chemicals released into the blood and tissues as part of the body's defense to damage by infection or inflammation. Interferons are used to treat a number of conditions including Multiple Sclerosis.

Ipecac
A substance derived from the ipecacuanha plant root and used to induce vomiting.

Ischaemia
A situation of oxygen deprivation. Prolonged oxygen deprivation in the brain results in permanent damage, commonly described as a stroke. The usual cause is a blood clot in an artery supplying the brain tissue.

Leukotrienes
A group of lipids which act as chemical messengers within the body.

Levo DOPA
The standard treatment for Parkinson's disease. This substance is the building block for the manufacture of dopamine by nerve cells, which is the primary deficit in PD. Long term L-DOPA treatment results in dyskinesias.

Ligands
A general term to describe substances (such as drugs) which bind to receptors.

LTB 4
One of the leukotrienes.

MAA
Marketing Authorisation Application â€` an application to a drug regulatory authority in Europe for approval to market a drug.

MAO-B inhibitors
Drugs which slow the metabolic breakdown of dopamine by the enzyme monoamine oxidase (MAO), which can help relieve the symptoms of Parkinson's disease.

Metabolism
The effect of the body on an administered compound which results in its transformation into other compounds prior to excretion.

NCE
New Chemical Entity. A newly identified molecule with a novel structure.

NDA
New Drug Application â€` an application to the FDA for approval to market a drug.

Neurogenic
Caused by the nervous system.

Neurological
Relating to the nervous system.

Neuropathic
A term to describe a particular form of pain which is caused by damage to nerves. Burns, viral infections (eg shingles), diabetes, cancer, disc problems, amputation (phantom limb) and certain chemicals can give rise to neuropathic pain which is dificult to treat with currently available medicines.

Neurotoxicity
Toxicity to the nervous system.

Neurotransmitter
A chemical mediator released from nerve terminals in response to nerve stimulation and which binds to receptors which are on the surface of other nerve cells. There are a number of different classes of neurotransmitters as well as many different receptor types and subtypes.

NMDA
N-methyl, D-aspartate - a subtype of glutamate receptor.

Nociception
Describes the sensation of pain. Nociceptive stimuli are painful stimuli.

NSAIDs
Non-Steroidal Anti-Inflammatory Drugs, used to treat pain. Examples include Brufen, Voltarol etc.

Opiates
Drugs derived from opium, such as heroin and morphine.

Pharmacodynamics
The study of the interaction of pharmacologically active compounds at their sites of action and their biological effects.

Pharmacoeconomics
The determination of the economic value that a treatment regime provides â€` often compared with other established therapies.

Pharmacokinetics
The absorption, distribution, metabolism and excretion of a drug by the body, studied over a period of time.

Phase I
Studies in healthy subjects to determine biological properties including, pharmacological activity, pharmacokinetics and tolerability of a new drug.

Phase IIa
Studies in a small number of patients to make a preliminary determination of efficacy and safety of a new drug to provide proof of the concept.

Phase IIb
Studies in a larger number of patients to determine the range of doses to be used in the Phase III clinical trials.

Phase III
Full scale clinical trials to determine efficacy and safety of a drug prior to seeking marketing approval.

Phase IV
Large scale clinical trials carried out after regulatory approval designed to expand experience of the efficacy and safety of the drug, often in comparison with other treatments. Sometimes referred to as marketing support trials.

Placebo
An inactive substance used as a comparison with an active drug.

Plasma
This describes what is left in blood once the cells (red cells, white cells) have been removed.

Post Herpetic Neuralgia
A form of neuropathic pain that results from infection with Herpes Virus (the common term is shingles).

Pre-clinical studies
In vitro or in vivo non-clinical studies performed to determine safety, pharmacological activity and product quality.

Prophylactic
Designed to prevent, as opposed to treat, a disease or condition.

Receptor
A protein located on a cell membrane or within the cell with which a hormone, neurotransmitter or drug interacts to produce or prevent a biological response.

Renal
Pertaining to the kidney.

Stability
The study of the integrity of a drug substance or finished product over time under various, well defined and controlled storage conditions.

Stroke
Cerebral ischaemia (lack of oxygen to the brain) is usually as result of blockage or rupture of a blood vessel in the brain giving rise to the risk to permanent brain damage. The type of disability the patient suffers is determined by the position and the extent of the damaged area. About 30% of strokes are fatal.

Subarachnoid space
Space between the arachnoid membrane of the brain and another membrane (piamater) which is in direct contact with the central nervous system.