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Definition List for Drug Safety Form
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People also ask
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What is listedness in pharmacovigilance?
Listed: If any adverse reaction is Well Documented in the CDC/CCSI, it is classified as Listed. Unlisted: If any adverse reaction is Not Well Documented in the CDC/CCSI, it is classified as Unlisted. -
What is the IME list used for?
The IME list aims to facilitate the classification of suspected adverse reactions as well as aggregated data analysis and case assessment for the day-to-day pharmacovigilance activities of stakeholders in the EU. The list is for guidance purposes only. -
What is a signNow medical event?
Important medical events that may not be immediately life threatening or result in death or hospitalisation but may jeopardise the patient or require intervention to prevent one of the other outcomes listed in the definition of seriousness (death, life threatening, hospitalisation or extended existing hospitalisation, ... -
What is IME and DME in pharmacovigilance?
IME list can be used to facilitate seriousness assessment of AEs. Page 8. Designated medical. event (DME) DMEs are serious and rare medical events that are often causally associated with drugs across multiple pharmacological/therapeutic classes. -
What is an example of a medical event?
Other Serious (Important Medical Events) Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. -
What is the definition of drug safety?
Drug safety refers to the frequency of adverse drug effects (i.e., physical or laboratory toxicity that could possibly be related to the drug) that are treatment emergent—that is, they emerge during treatment and were not present before treatment, or they become worse during treatment compared with the pretreatment ... -
What measures the safety of drugs?
The Therapeutic Index (TI) is used to compare the therapeutically effective dose to the toxic dose of a pharmaceutical agent. The TI is a statement of relative safety of a drug. It is the ratio of the dose that produces toxicity to the dose needed to produce the desired therapeutic response. -
What is the difference between IME and DME list?
IME list can be used to facilitate seriousness assessment of AEs. DMEs are serious and rare medical events that are often causally associated with drugs across multiple pharmacological/therapeutic classes. DMEs are serious, rare and often causally associated with drugs.
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