N-T
The following abbreviations and expressions have the following meanings when used in this report:
new chemical entity (NCE)/new molecular entity (NME) A new, pharmacologically-active substance. The term is used to differentiate from line extensions and existing drug products. NCE is a term referring to chemical substances whereas NME covers all modalities.
new drug application (NDA) An application to the US Food and Drug Administration for approval to market a new medicine in the US.
NYSE New York Stock Exchange.
operating costs Distribution costs, research and development costs and selling, general and administrative costs.
operating profit Sales, less cost of sales, less operating costs, plus operating income.
Ordinary Shares Ordinary Shares of $0.25 each in the capital of the Company.
outcomes study A clinical trial (usually large) assessing the effect of a drug in preventing or delaying a specific and important medical event (for example the occurrence of a heart attack).
parenteral Administered by injection (for example intravenous, sub-cutaneous and intramuscular).
Pharmaceutical Research and Manufacturers of America (PhRMA) The principal US pharmaceutical industry association.
pharmacovigilance The scientific collection and evaluation of information from healthcare providers and patients relating to the adverse effects of medicines.
Phase I The phase of clinical research where a new drug or treatment is tested in small groups of people (20 to 80) to check that the drug can achieve appropriate concentrations in the body, determine a safe dosage range and identify side effects. This phase includes healthy volunteer studies.
Phase II This phase of clinical research includes the controlled clinical activities conducted to evaluate the effectiveness of the drug in patients with the disease under study and to determine the common short-term side effects and risks associated with the drug. Phase II studies are typically conducted in a relatively small number of patients (usually no more than several hundred).
Phase III This phase of clinical research is performed to gather additional information about effectiveness and safety of the drug, often in a comparative setting, to evaluate the overall benefit/risk profile of the drug. Phase III studies usually include between several hundred and several thousand patients.
placebo In clinical trials, an inert substance identical in appearance to the substance being tested, also known as a sugar pill.
poly-ADP-ribose polymerase (PARP) An enzyme critical to the repair of damaged cells and maintenance of cellular energy.
pre-clinical studies Studies conducted before a drug is tested in human subjects, and which support and help establish boundaries for safe use of the drug in subsequent Phase I studies.
pressurised metered dose inhaler (pMDI) An aerosol inhaler/puffer device for delivering medicine directly into the lungs.
primary care The medical care that a patient receives upon first contact with the healthcare system, before referral elsewhere within the system.
profit before tax Operating profit, plus finance income, less finance expense.
ROW Rest of World.
second-line treatment Treatment administered after the failure of, or in addition to, first-line therapy.
Securities and Exchange Commission (SEC) US governmental agency that regulates the securities industry/stock market.
Senior Executive Team (SET) Team of heads of the various AstraZeneca functions.
SG&A costs Selling, general and administrative costs.
siRNA molecules Small or short or silencing interfering RNA. A class of 20-25 nucleotide double stranded RNA molecules that interfere with the expression of a specific gene. In this specific case, siRNA is a type of anti-viral agent.
small molecule A general term used to describe pharmaceutical R&D using chemistry and chemical methods and materials to discover and develop new medicines. Chemical molecules are small compared with biological molecules.
specialist care The medical care the patient receives after being referred by the primary care provider.
sterling, £, GBP, pence or p References to the currency of the UK.
supplemental new drug application (sNDA) An application made to the US Food and Drug Administration to seek approval to market an additional indication for a drug already on the market.
TSR Total shareholder return.
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Abbreviations/expressions and their meanings, when used on this website
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