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Adverse event. In pharmaceuticals, an adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended symptom or sign ...
In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose. Results in death. Is life-threatening. Requires inpatient hospitalization or causes prolongation of existing hospitalization. Results in persistent or significant disability/incapacity.
Psychopharmacology (from Greek ψῡχή, psȳkhē, 'breath, life, soul'; φάρμακον, pharmakon, 'drug'; and -λογία, -logia) is the scientific study of the effects drugs have on mood, sensation, thinking, behavior, judgment and evaluation, and memory. It is distinguished from neuropsychopharmacology, which emphasizes the correlation ...
Pharmacology. An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. [ 1 ] An adverse effect may be termed a " side effect ", when judged to be secondary to a main or therapeutic effect. The term complication is similar to adverse effect, but the latter is typically used in ...
An adverse event (AE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not the event is associated with the administration of the drug. [1]: 1.2 Adverse Event (AE) An ADR is a special type of AE in which a causative relationship can be shown. [3] ADRs are only one type of medication-related harm.
Clinical endpoint. Clinical endpoints or clinical outcomes are outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then ...
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration 's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might ...
In the United States, a boxed warning (sometimes " black box warning ", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize it is of ...