Glossary
Here are some definitions for words and abbreviations we commonly use:
Adjuvant
A pharmacological agent added to a drug to increase or aid its effect
Angiotensin
A protein in the blood that causes vascoconstriction, increased blood pressure, and release of aldosterone from the adrenal cortex
Antibody
A molecule produced by cells of the immune system which bind to parts of other molecules in a highly specific way which may neutralise their effect
Antidote
A remedy to relieve, prevent, or counteract the effects of a poison
Antigen
A substance that stimulates an immune response
B-cell
A type of lymphocyte (white blood cell)
B-cell lymphocytic leukaemia (B-CLL)
A type of cancer in which B-cells over accumulate
Biological License Application (BLA)
US equivalent of a MAA for a biological product
Caricotamide
A cosubstrate present in Prolarix™
Chromatography
A method of separating a mixture of proteins by passing a fluid containing the mixture over a stationary material, which may be porous
Clinical development
The stage of pharmaceutical research and development where potential drugs are studied in human clinical trials
Cosubstrate
A second or other substrate required by enzymes to carry out catalysis
Crotalid
Any snake of the family Crotalidae, also called pit viper, which includes rattlesnakes
Cytotoxic
A molecule or drug that is toxic to cells
Cytokine
A cellular messenger, typically of the immune system
EDLFs
Endogenous Digoxin-like Factors
EMEA
European Medicines Evaluation Agency
Endogenous enzyme
An enzyme that naturally occurs in cells or tissues
Envenomation
The injecting of a poisonous material (venom) via a bite or other means
Ex vivo
A test performed outside the body on a sample taken from a living organism
Fab
Part of an antibody molecule which can be split from the whole molecule and which still retains its binding capability
FDA
US Food and Drug Administration; the government body responsible for regulating pharmaceuticals in the US
HDMTX
High dose methotrexate, defined as concentrations in excess of 1g/m2
Hypertension
Blood pressure that is above medically defined normal limits and which is associated with increased risks of stroke and heart disease
ICU
Intensive Care Unit
In vitro
A test or technique performed in a controlled environment generally separate from the whole organism
Leucovorin (also known as folinic acid)
An adjuvant used in cancer treatment to reduce the toxicity of the chemotherapy agent methotrexate or to enhance the cytotoxic (anti-tumour) activity of the chemotherapy agent 5-fluorouracil
Marketing Authorisation Application (MAA)
The complete set of data supporting the quality, safety and efficacy of a medicinal product which is submitted to a regulatory agency in order to obtain market approval in the EU
MHRA
Medicines and Healthcare Products Regulatory Health Agency
Methotrexate (MTX)
A cytotoxic agent commonly used in the treatment of certain cancers
Named patient sales
The supply of a medical product to a doctor for the treatment of specific patients, prior to granting of a MAA, when no other effective treatments are available
Pharmacokinetics
The process by which a drug is absorbed, distributed, metabolised and eliminated from the body
Phase 1 study
The clinical assessment of the safety, pharmacodynamics and/or pharmacokinetics of a drug candidate in healthy human subjects
Phase 1/2 study
As for phase 1 study, but clinical assessment conducted in patients
Phase 2 study
The clinical assessment in patients of a drug to determine dose range and preliminary efficacy. A phase 2a study is to examine the pharmacological effect of the drug and a phase 2b is to evaluate the appropriate dose for phase 3
Phase 3 study
The clinical assessment of efficacy and safety of a drug, usually in comparison with a marketed drug or placebo, in the patient population for which it is intended to be used
Polyclonal antibody
A mixture if antibodies produced in response to a specific antigen, that bind to different parts of the antigen
Pre-eclampsia
A potentially life-threatening condition of pregnancy characterised by high blood pressure and protein in the urine
Prodrug
An inert chemical which can be activated within the body to an active substance
Proof of concept
Studies in animal or man to demonstrate the expected action of the drug
®
A trademark which has been registered both in the US and an EU member state
Sepsis
An inflammatory condition caused by the body’s exaggerated response to infection or injury. The defining characteristics are inflammation, abnormal vital signs and failure of one or more major organ systems
Treatment Protocol
An FDA initiative to allow critically ill patients to be given experimental drugs
Tretazicar
The cytotoxic prodrug component of Prolarix™
Therapeutic
A product to treat a disease
TNF Tumour
necrosis factor alpha, a cytokine, involved in the body inflammatory process
™
An application to register the trademark is pending in either the US or an EU member state
Vaccine
A substance used to stimulate an immune response to raise antibodies against the target substance
Vasoactive substances
Substances that dilate or constrict blood vessels
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