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Glossary

Antagonist

a substance which blocks the effects of another substance by binding to a cell receptor without eliciting a response

 

Buccal

pertaining to the mouth

Dose-dependent

this is said to occur when the effects of a drug are dependent on the dose used

  

Endocrinology

the scientific study of the function and pathology of the endocrine glands (for example the thyroid gland, pituitary gland, etc.)

 

Endometriosis

a condition in which the endometrium (the cells lining the interior of the uterus) is found in other parts of the body

 

Erectile Dysfunction

the inability to achieve or sustain an erection suitable for sexual intercourse

 

FDA

Food & Drug Administration, the consumer protection agency responsible for public health in the USA. It regulates drug licensing in the USA and ensures that safe and effective products reach the market in a timely manner

 

GnRH

gonadotrophin releasing hormone, the key chemical messenger by which the human brain (via the pituitary gland) controls the release of primary sex hormones such as testosterone in men and oestradiol in women

 

Growth Hormone

a polypeptide hormone synthesised and secreted by the anterior pituitary gland which stimulates growth and cell reproduction

 

Growth Hormone Secretagogue (GHS)

a synthetic molecule that triggers growth hormone release in the body

 

Gynaecology

a branch of medicine dealing with the diagnosis and treatment of disorders affecting the female reproductive organs

 Hormone

a naturally occurring substance secreted by specialised endocrine cells and transported in the blood to regulate the functions of tissues and organs elsewhere in the body

 

Hypogonadism

a condition characterised in men by under–activity of the testes, resulting in low levels of testosterone

 

IM

intramuscular

 

IND

Investigational New Drug, an application, and authorisation of a clinical trial(s), particularly in the USA

 

LA

long acting

 

Lipodystrophy

a disturbance of fat distribution and fat metabolism

 

MRC

Medical Research Council

 

Mutual Recognition Procedure

the process whereby a marketing authorisation obtained in one member state within the European Union is mutually recognised by other member states in accordance with Directive 2001/83/EC of the European Parliament and Council (as amended by Directive 2004/27/EC of the European Parliament and Council)

 

Obstetrics

a branch of medicine dealing with the care of women during pregnancy, childbirth, and the period during which they recover from childbirth

 

Oestrogen/Oestradiol

female sex hormones whose function includes inducing the changes in the uterus that precede ovulation and also the development of secondary sexual characteristics

 

Overactive Bladder (OAB)

a condition characterised by involuntary bladder muscle contractions during the bladder filling phase which the patient cannot suppress

 Pharmacokinetic

relating to the disposition of drugs in the body (ie their absorption, distribution, metabolism and elimination)

 

Phase I trial

the first studies in man with a new drug, usually conducted in normal, healthy volunteers. The main aim is to determine the safety of the new drug as well as study the pharmacological effects of the drug

 

Phase II trial

the first clinical studies with a new drug in patients. These studies aim to confirm that the drug has a therapeutic effect (often referred to as clinical "proof of concept") and to determine optimal dosing before embarking on the larger Phase III studies 

Phase III trial

these trials assess whether the drug (used at a particular dose, in a specific population and in a particular formulation) has a favourable risk–benefit profile in a large group of patients. The "pivotal"  phase III trial  should provide statistically sound evidence of efficacy and safety

 

Pituitary Gland

a small oval shaped endocrine gland situated at the base of the brain in the fossa (depression) of the sphenoid bone, which regulates growth and metabolism. The gland is divided into the posterior and anterior pituitary, each responsible for the production of its own unique hormones.

 

Prostate Gland

the gland responsible for secreting seminal fluid

 

Prostate Cancer

a malignant tumour of the prostate; it is the second most common malignancy in men

 

Receptor

a molecule located within a cell or on the surface of a cell, to which an agonist or antagonist will bind; as a result of that binding, a biological response is produced or blocked

 

SC

subcutaneous

 

Serum

the clear liquid that separates from blood on clotting

 

SR

sustained release

 

Subcutaneous

under the skin

 

Testosterone

the principal male sex hormone secreted by the testes

 

Transdermal

entering through the skin (or dermis), as is the case with certain drugs that are applied to the skin in cream or patch form

 

 

Urology

a branch of medicine concerned with the diagnosis and treatment of diseases of the urinary tract and urogenital system

 

Uterus

the hollow muscular organ in females in which the fertilized ovum normally becomes embedded and in which the developing baby is nourished