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Our Science Glossary glossary_p

Glossary

PMDA or Pharmaceutical and Medical Devices agency

The Japanese government agency that provides advice on, and conducting reviews of, the quality, efficacy, and safety of pharmaceuticals and medical devices through a consistent structure from pre-clinical trial to review (Approval Review); and collecting, analyzing, and providing information pertaining to postmarketing safety (Safety Measures).

Parkinson's disease

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.

Pathophysiology

The functional changes associated with or resulting from disease or injury.

PEGylated

PEGylation is a process of attaching the strands of the polymer polyethylene glycol or PEG to molecules, most typically peptides, proteins and antibody fragments, that can help to improve the safety and efficiency of many therapeutics. The physical and chemical changes created increase systemic retention of the therapeutic agent; influence the binding affinity of the therapeutic moiety to the cell receptors and can alter the absorption and distribution patterns.

Personalised medicine

The use of detailed information about a patient's genotype (the entire genetic makeup of an individual organism) or level of gene expression and a patient's clinical data in order to select a medication, therapy or preventative measure that is particularly suited to that patient at the time of administration. The benefits of personalised medicine are in its accuracy, efficacy, safety and speed. The term emerged in the 1990s when the human genome was being decoded.

Pharmacodynamics

The effects of drugs on tissues and organs.

Pharmacology

The study of how drugs affect a living organism or cell.

Pharmacokinetics

The study of absorption, distribution, metabolism and excretion of a drug.

Pharmacophore

First defined by Paul Ehrlich in 1909 as a molecular framework that carries the essential features responsible for a drug's biological activity: In modern computational chemistry, pharmacophores are used to define the essential features of one or more molecules with the same biological activity. A database of diverse chemical compounds can then be searched for more molecules which share the same features located a similar distance apart from each other.

Phenotype

Physical, clinical or biological characteristics of an organism, determined by the interaction of its genetic make-up with the environment.

Placebo

A dose that looks like the medicine being tested but in fact contains no medical ingredients and which is used as part of a control group during Phase III clinical trials.

Pre-clinical trials

A stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. The main goals of pre-clinical studies are to determine a drug's pharmacodynamics (PD), pharmacokinetics (PK), ADME and toxicity.

Proof-of-concept

A study that demonstrates an effect on a clinical endpoint that is either an accepted regulatory endpoint or is known to be highly predictive of that endpoint. Proof-of- concept needs to be carried out in patients with the disease in question. This is often a Phase II trial.

Protein

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 is usually above 100,000.

Protein expression

The measure of the presence and amount of one or more proteins in a particular cell or tissue. The translation of information encoded in a gene into protein or RNA.

Psoriasis

A chronic skin condition characterised by inflamed, red, raised areas that develop silvery scales or plaques. Plaques frequently occur on the skin of the elbows and knees, but can affect any area including the scalp and genitals.