A group of people

Glossary of terms

P

Palliative

Treatment that has no curative intent but is given to maintain quality of life and to relieve suffering in a terminally-ill patient.

Parenteral

Administered by injection (for example intravenous, sub-cutaneous and intramuscular).

Parkinson’s Disease

A neurological disorder caused by degeneration of or damage to nerve cells in the brain.

Perennial Rhinitis

A year round inflammatory nasal disorder.

Peripheral or Cutaneous T-Cell Lymphoma (PCTL/CTCL)

Both are specific types of non-Hodgkin’s lymphoma.

Phage

The abbreviation for bacteriophage, a virus that infects bacteria.

Phage display

A test to screen for protein interactions using multiple gene sequences and bacteriophages.

Pharmaceutical and Medical Devices Agency (PMDA)

The Japanese regulatory authority for medicines and medical devices, part of the MHLW.

Pharmaceutical Research and Manufacturers of America (PhRMA)

The principal US pharmaceutical industry association.

Pharmacogenomics

A biotechnological science that combines the techniques of medicine, pharmacology and genomics and is concerned with developing drug therapies to compensate for genetic differences in patients which cause varied responses to a single therapeutic regimen.

Pharmacokinetics

The study of what the body does to a drug.

Pharmacology

The study of how drugs affect a living organism.

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 (twenty to eighty) to check that the drug can achieve appropriate concentrations in the body and, determine a safe dosage range, and identify side effects. This phase includes healthy volunteer studies.

Phase II

This phase of clinical study includes the 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 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 benefi t/risk profi le of the drug. Phase III studies usually include between several hundred and several thousand patients.

Phase IV

Post-marketing studies to delineate additional information about the drug’s risks, benefits and optimal use, including those that may be requested by regulatory authorities in conjunction with marketing approval.

PIE

Pharmaceuticals in the environment.

Placebo

In clinical trials, an inert substance identical in appearance to the substance being tested, also known as a sugar pill.

Platelets

The blood cells that form blood clots.

Poly-ADP-Ribose Polymerase (PARP)

An enzyme critical to the repair of damaged cells and maintenance of cellular energy.

Positron Emission Tomography (PET)

A highly specialised imaging technique that uses short-lived radioactive substances to produce three-dimensional coloured images of those substances functioning within the body. These images are called PET scans.

Post-marketing surveillance (PMS)

The systematic detection and evaluation of adverse reactions occurring in association with pharmaceutical products under customary conditions of use in ordinary clinical practice.

Pre-Clinical (PC) 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 the 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.

Prolactin

The hormone that stimulates milk production after childbirth.

Proof of Concept

Proof of concept provides clinical confirmation that an investigational product possesses a desired pharmacological effect in patients with the disease of interest. This can be achieved after a positive placebo-controlled study or doseresponse study using a validated surrogate variable or the final clinical outcome variable. Proof of concept also includes establishing a limited dose range to be used in the subsequent confirmatory studies.

Proof of Principle

Proof of principle is achieved when an intended pharmacological effect results in an expected change in a relevant biomarker in a dose range, which does not cause any major unwanted effects. Proof of principle therefore provides the first measurable evidence that an investigational product might work in humans. Proof of principle is normally demonstrated in a limited number of subjects with the disease of interest or in healthy volunteers when a relevant model exists.

Prophylaxis or Prophylactic Therapy

A therapy or measure used to prevent disease.

Proton Pump Inhibitor (PPI)

A medicine that reduces the production of acid in the stomach.

Psychiatry

The study, prevention and treatment of mental illnesses and emotional
and behavioural problems.