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Safety and tolerability
Safety and tolerability The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and haematology), vital signs, clinical adverse events (diseases, signs and symptoms), and other special safety, tests (for example, ECGs opthamology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject
RELATED TERMS--------------------------------------
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.
Medical
Pertaining to Medicine.
Risk
In clinical trials, the probability of harm or discomfort for subjects, arising from the test product. Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat, for example, will be expected to have a low incidence of side effects. However, unpleasant side effects may be an acceptable risk when testing a promising treatment for a life-threatening illness.
Clinical
That which can be observed in patients. Research that uses patients to test new treatments, as opposed to laboratory testing or research in animals.
SIMILAR TERMS--------------------------------------
Safe sex
Sex in a monogamous relationship where neither party is infected with a sexually transmitted disease or urinary tract infection is considered to be "safe." However, many healthcare professionals believe there really is no such thing as "safe" sex and the only way to be truly safe is to abstain because all forms of sexual contact carry some risk.
Safee Hospital
The Safee Hospital is a hospital in Karachi, Sindh, Pakistan.
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.
PREVIOUS AND NEXT TERMS--------------------------------------
Superantigen
An antigen that interacts with the T cell receptor in a domain outside of the antigen recognition site. This type of interaction induces the activation of larger numbers of T cells compared to antigens that are presented in the antigen recognition site.
Screening
Testing for disease in people without symptoms.
Silicosis
A form of chronic lung disease which develops after prolonged exposure to silica (quartz) dust.
SV40
Simian Virus 40, a monkey virus that contaminated the polio vaccine administered to 98 million Americans from 1955 to 1963, and has been associated with a number of rare human cancers. One controversial theory links SV40 to mesothelioma.
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.
Safety and tolerability
Serious adverse drug reaction (SADR)
A serious adverse event (SAE) which is possibly an adverse drug reaction (ADR)
Serious adverse event (SAE)
Any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. See adverse event (AE)
Single-blind study
One in which subjects do not know whether they are receiving the active drug or a placebo, but the investigator does know
Source data
All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies)
Sponsor
An individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial
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