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| API: |
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active pharmaceutical ingredient. |
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| Apomorphine
hydrochloride: |
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a type of dopaminergic agonist or a morphine
derivative that does not actually contain
morphine. Apomorphine is currently used in the treatment of
Parkinson's disease and erectile dysfunction. |
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| Asthma: |
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a condition in which individuals suffer from a
widespread narrowing of the bronchial airways, which changes in
severity over short periods of time, leading to cough, wheezing and
difficulty in breathing. |
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| B |
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| Beclometasone: |
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a steroid that is used to help prevent the
symptoms of asthma. |
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| Bioavailability: |
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the extent to which a drug is absorbed into the
bloodstream. |
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| Blending: |
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blending with lactose improves aerosol
performance, providing optimal deaggregation, reliable metering and
accurate dosing. The active drug molecules sit on the surface of
the lactose; once inhaled the drug particles detach from the
lactose and flow into the lower airways, and the lactose hits the
back of the throat and is swallowed. |
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| Bronchodilator: |
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a drug that relaxes and dilates the bronchial
passageways and improves the passage of air into the lungs.
Bronchodilators help breathing and relieve asthma symptoms
but not inflammation. |
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| Budesonide: |
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a steroid thatich is used to help prevent the
symptoms of asthma. |
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| C |
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| COPD: |
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chronic obstructive pulmonary disease is an
irreversible and chronic obstruction of the airways, caused
primarily by smoking. Conditions of COPD include chronic
bronchitis and emphysema, sometimes both. The disease
progresses and eventually leads to a largely irreversible loss of
lung function. |
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| Cystic fibrosis: |
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a genetic disease involving a sticky build-up of
mucus in the lungs (which makes breathing difficult and leads to
infections) as well as pancreatic insufficiency (which leads to
digestive problems). |
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| D |
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| Diabetes: |
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a chronic health condition where the body is
unable to produce or adequately use insulin. Symptoms include
thirst, excessive urination, dehydration and weight loss. The
treatment of diabetes may require daily insulin injections, proper
nutrition and regular exercise. |
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| DPI: |
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dry powder inhaler. |
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| E |
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| Erectile
dysfunction: |
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(or impotence) is a sexual dysfunction
characterised by the inability to develop or maintain an erection.
There are various underlying causes, such as diabetes, many of
which are medically reversible. |
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| Excipient: |
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an inactive ingredient added to a drug (i.e. in
pill form) to dilute it or to give it form, consistency or
stability. |
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| F |
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| Factor VIII: |
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an essential factor necessary for blood to clot.
The lack of normal Factor VIII causes haemophilia A, an inherited
bleeding disorder. |
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| FDA (Food and Drug
Administration): |
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part of the US Department of Health and Human
Services Agency responsible for ensuring the safety and
effectiveness of all drugs, biologics, vaccines, and medical
devices. |
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| Fibrinogen: |
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a protein used in coagulation. It reacts with
other molecules to produce blood clots. |
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| Formoterol: |
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belongs to the family of medicines known as beta-2
agonists. It is used to help treat or relieve the symptoms of
asthma. |
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| G |
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| GCP (Good Clinical
Practice): |
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the standard for the design, conduct, performance,
monitoring, auditing, recording, analysis and reporting of clinical
trials that provides assurance that the data and reported results
are credible and accurate and that the rights, integrity, and
confidentiality of trial subjects are protected. |
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| GLP (Good Laboratory
Practice): |
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a compliance-monitoring programme, through
laboratory inspections and data audits, which assures the quality
and integrity of test data. |
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| GMP (Good Manufacturing
Practice): |
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a European standard required by companies that
produce pharmaceuticals and medical devices and which is
administered and monitored in the UK by the Medicines and
Healthcare Products Regulatory Agency (MHRA). |
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| Haemophilia A: |
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a disorder of the blood in which it lacks an
agent, known as Factor VIII, to make it clot. |
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| Hyaluronic acid: |
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a natural component of connective tissue,
including the skin, which plays a critical role in providing volume
to skin by retaining water. It may be manufactured by
bacterial fermentation. |
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| Hypomobility: |
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a decrease in the normal range of joint
movement. |
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| I |
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| Icodextrin: |
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is a high molecular weight starch-like molecule
that may be used in solution to act as a peritoneal dialysate or as
a means to reduce post-surgical adhesion
formation. |
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| IND or Investigational New
Drug: |
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an IND is the authorisation from the FDA to
administer a new drug to humans in clinical trials. |
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| Lactose: |
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a type of sugar found in milk and milk
products. |
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| M |
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| Macromolecules: |
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large molecules in biological systems, namely
proteins, nucleic acids and polysaccharides. |
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Meptin®
(procaterol): |
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a beta-2 agonist developed by Otsuka used to treat
the symptoms of asthma, chronic bronchitis, emphysema, and other
lung diseases. |
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| MHRA: |
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Medicines and Healthcare Products Regulatory
Agency. |
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| Micron: |
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one thousandth of a millimetre. |
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| Micronisation: |
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the process in which the active ingredient of
a drug is milled to microscopic size by particle to
particle collision. At this point the drug particles become highly
cohesive and will not flow or disperse easily and need to be
blended. |
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| Migraine: |
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A headache characterised by throbbing head pain,
often greater on one side; may be preceded by a warning (aura) and
accompanied by nausea, vomiting, and sensitivity to light and
sound; in rare cases, weakness, language problems, or other
neurologic disorders are associated with migraine. |
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| Muscarinic
antagonist: |
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is a long-acting anticholinergic bronchodilator
used in the management of chronic obstructive pulmonary disease
(COPD). |
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| Mutual Recognition
Procedure: |
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a marketing authorisation for a pharmaceutical
product in more than one country in the European Union. It
may be applied for through one of three procedures: the
Centralised Procedure, the Mutual Recognition Procedure (MRP), or
the Decentralised Procedure. |
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| N |
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| NCE: |
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a New Chemical Entity, or new drug. |
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| Orphan Drug
Status: |
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Orphan Drug Status may be granted to a drug by the
Office of Orphan Products Development in the US or the European
Medicines Agency (EMEA) in Europe. It is designed to encourage the
development of drugs that are necessary but would be prohibitively
expensive/unprofitable to develop under normal circumstances and
provides tax incentives and other advantages to companies engaged
with the development of such drugs. |
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| Parkinson’s
disease: |
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a progressive disorder of the nervous system
marked by muscle tremors, muscle rigidity, decreased mobility,
stooped posture, slow voluntary movements, and a mask-like facial
expression. |
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| Peptide: |
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a molecule composed of two or more amino acids.
Larger peptides are generally referred to as polypeptides or
proteins. An amino acid is any class of 20 molecules that are
combined to form proteins in living things. The sequence of amino
acids in a protein and hence protein function are determined by the
genetic code. |
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| Peritoneal: |
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of the peritoneum, which is the membrane that
forms the lining of the abdominal cavity. |
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| Phase I: |
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a clinical trial that includes the initial
introduction of an investigational new drug or IND into humans.
Phase I trials are typically closely monitored and may be conducted
in patients or normal volunteer subjects. These trials are designed
to determine the metabolism and pharmacology of the drug in humans,
the side effects associated with increasing doses, and, if
possible, to gain early evidence of effectiveness. During Phase I,
sufficient information about the drug’s pharmacokinetics and
pharmacological effects should be obtained to permit the design of
well-controlled, scientifically valid Phase II trials. The total
number of subjects and patients included in Phase I trials varies
with the drug, but is generally in the range of
20–80. |
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| Phase II: |
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a clinical trial that
includes controlled clinical activities conducted to evaluate
the effectiveness of the drug for a particular indication or
indications in patients with the disease or condition under study,
and to determine the common short-term side effects and risks
associated with the drug. Phase II trials are typically well
controlled, closely monitored and conducted in a relatively small
number of patents, usually involving no more than several hundred
subjects. |
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| Phase III: |
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clinical trials performed after preliminary
evidence suggesting effectiveness of the drug has been obtained,
and intended to gather additional information about
effectiveness and safety that is needed to evaluate the overall
benefit–risk relationship of the drug and to provide an
adequate basis for physician labelling. Phase III trials usually
include from several hundred to several thousand
subjects. |
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| Polyol
stabilisation: |
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may be used to stabilise peptides and proteins.
The incorporation of trehalose into a dry powder formulation
utilising spray drying or foam drying offers the potential of room
temperature stability to the resulting formulation, avoiding the
need for refrigerated storage. |
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| Premature
ejaculation: |
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sexual dysfunction characterised by the inability
to control or delay ejaculation as long as desired. |
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Proof-of-principle: |
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a study that demonstrates an effect that results
in a biological change that is closely related to the proposed
mechanism of action and known to be associated with disease
activity in patients. Proof-of-principle can also be carried out in
patients or healthy volunteers using appropriate challenge agents
provided that a clear link can be established between the effect
and the target disease. |
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| Protein: |
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a molecule composed of a long chain of amino
acids. Proteins are the principal constituents of cellular material
and serve as enzymes, hormones, structural elements, and
antibodies. The molar mass of a protein is usually above
100,000. |
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| Pulmonary controlled
release: |
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uses oligosaccharide ester derivatives (a modified
carbohydrate matrix) or hyaluronic acid encapsulation of the active
pharmaceutical ingredient to enable controlled drug release within
the lung. The powder formulations that combine the active drug and
the excipient controlling the rate of release are obtained through
the use of spray drying. |
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| Pulmonary
hypertension: |
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high blood pressure in the blood vessels of the
lungs, which if left untreated may lead to heart failure. |
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| S |
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| Salbutamol: |
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a beta-2 agonist used to treat wheezing, shortness
of breath and troubled breathing caused by asthma, chronic
bronchitis, emphysema and other lung diseases. |
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| Spray drying: |
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applicable to a wide range of materials and may be
used for macromolecules, e.g. proteins and peptides, as well as
small molecules. The process gives control over target particle
characteristics important for pulmonary drug delivery and produces
particles designed for better, deeper lung delivery. In addition,
the inclusion of non-active excipients such as trehalose or
hyaluronic acid can stabilise and alter the kinetics of the active
pharmaceutical ingredient. Spray drying is also suitable for the
preparation of other solid dose formats. |
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| T |
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| Thrombin: |
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an enzyme that converts fibrinogen to
fibrin. |
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| Trehalose: |
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a disaccharide or sugar found in invertebrates,
bacteria, algae and fungi that may be used to stabilise protein
structures. |
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