Medical Glossary

This glossary contains:
19186
medical terms

Postmarketing surveillance




Postmarketing surveillance

ongoing safety monitoring of marketed drugs. See Phase 4 studies, Phase 5 studies.

RELATED TERMS
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Safety
relative freedom from harm; in clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests and procedures, psychiatric evaluation, and/or physical examination of subjects.

Monitoring
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (S0Ps), good clinical practice (GCP), and the applicable regulatory requirement(s).



SIMILAR TERMS
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Post
Thin metal rod inserted into the root of a tooth after root canal therapy; provides retention for a "coping" that replaces lost tooth structure and retains crown.

Post partum
Post partum refers to the period after childbirth.

Post stimulus time histogram
A method for examining cell response to a particular stimulus. The time after stimulus onset is divided into a number of bins. The stimulus is then presented repeatedly and the count in each bin increased each time the cell fires during that time bin.

Post-core
Post and buildup to replace lost tooth structure and retain crown.

Post-crown
Single structure that combines post-core and crown.

Post-traumatic stress disorder (PTSD)
A syndrome caused by re-experiencing traumatic events while being unaware of or unresponsive to current events or, in other words, a "flashback." A child may experience sleeping problems, nightmares, intrusive thoughts, have difficulty concentrating, self-destructive behavior, hyperactivity or anxiety/panic disorder. Therapy is crucial in managing PTSD.

Postcholecystectomy syndrome
A condition that occurs after gallbladder removal. The muscle between the gallbladder and the small intestine does not work properly, causing pain, nausea, and indigestion. Also called biliary dyskinesia.

Posterior
At or toward the back.

Posterior parietal cortex
Concerned with the perception of the spatial relations among objects.

Postgastrectomy syndrome
A condition that occurs after an operation to remove the stomach (gastrectomy). See also dumping syndrome.

Postmature
An infant born at 42 weeks or more is considered postmature. As withprematurity, being postmature can lead to complications; the baby may belarger and less able to pass through the birth canal or the placenta may nolonger be able to provide adequate oxygen or nutrition.

Postnatal care
Medical care for both newborn and mother during the first 6 weeks after birth.

Postnatal Depression
Depression in women occurring usually within four weeks after the delivery of a child. The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders.

Postoperative
After surgery.

Postpartum
After childbirth.

Postpartum depression
More severe than the more common and milder baby blues, postpartumdepression is characterized by sadness, impatience, restlessness, and inability to care for the baby.

Postprandial
Occurring after a meal. Example: Blood taken 1-2 hours after eating to see the amount of glucose in the blood would be called a postprandial blood glucose test.

Postural Orthostatic Tachycardia Syndrome (POTS) (Neurocardiogenic Syncope, Dysautonomia)
Dysfunction of the autonomic nervous syndrome. Causes symptoms of fatigue, dizziness, increased heart rate, and other symptoms. See syncope.

Postural tremor
A tremor of a limb that increases when the limb is stretched.

Posturography
A force platform that evaluates somatosensory and visual influences on posture and equilibrium.

Postvagotomy stasis
Delayed stomach emptying; occurs after surgery on the vagus nerve.



PREVIOUS AND NEXT TERMS
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Pharmacology
The science that deals with the characteristics, effects, and uses of drugs and their interactions with living organisms.

Phases of clinical trials
Clinical trials are generally categorised into four (sometimes five) phases. An investigational medicine or product may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases.

Phase 2a studies
Pilot clinical trials to evaluate efficacy and safety in selected populations of about 100 to 300 patients who have the disease or condition to be treated, diagnosed, or prevented. Often involve hospitalised patients who can be closely monitored. Objectives may focus on dose-response, type of patient, frequency of dosing, or any of a number of other issues involved in safety and efficacy.

Phase 3 studies
Multicentre studies in populations of perhaps 1000 to 3000 patients (or more) for whom the medicine is eventually intended. Phase 3 trials generate additional safety and efficacy data from relatively large numbers of patients in both controlled and uncontrolled designs and are used to support a PLA. Trials are also conducted in special groups of patients or under special conditions dictated by the nature of a particular medicine and/or disease. Phase 3 trials often provide much of the information needed for the package insert and labelling of the medicine.

Phase 5 studies
Postmarketing surveillance is sometimes referred to as Phase 5.

Postmarketing surveillance

Prospective study
Investigation in which a group of subjects is recruited and monitored in accordance with criteria described in a protocol.

Protocol amendment
A written description of a change(s) to or formal clarification of a protocol.

Pulmonary embolism
Blockage of one or more of the pulmonary arteries by a blood clot.

Psychokinesis (PK, cryptokinesis, telekinesis, telergy)
Alleged production or control of motion, or influencing of an event, mentally, without the use of bodily mechanisms. The word "telekinesis" implies involvement of the occult.

Psychospiritual
Pertaining to mental health and spirituality.

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This dictionary contains 19186 terms.







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