What is the safety profile?
The chemistry, pharmacology, therapeutic effects, and adverse effects of an administered drug or other substance.
What is a safety profile of a medication?
Drug safety monitoring Revealing, registration and analysis of the ADR (Pharmacovigilance) are necessary for the subsequent specification of the drugs’ indications, contra-indications, side effects, dosages, etc.
What is MAAE clinical trial?
Safety data submitted for vaccine clinical trials should include reactogenicity data (i.e., a set of prespecified AEs collected within a prespecified time frame, often referred to as solicited AEs or reactions), unsolicited AEs, medically attended adverse events (MAAEs), and death.
What is affinity and efficacy?
Affinity describes strength of drug binding with receptor (“fit the lock”). Efficacy describes ability of drug-bound receptor to produce a response (“turn the key”). Agonists have both affinities for the receptor as well as efficacy but antagonists have only affinity for the receptors and no (zero) efficacy.
What is the difference between safety and efficacy?
Obviously, a drug (or any medical treatment) should be used only when it will benefit a patient. Benefit takes into account both the drug’s ability to produce the desired result (efficacy) and the type and likelihood of adverse effects (safety).
What is unsolicited adverse?
The collection of AE data by a registry is generally either intentionally solicited (meaning that the data are part of the uniform collection of information in the registry) or unsolicited (meaning that the AE information is volunteered or noted in an unsolicited manner and not as a required data element through a case …
What is a medically attended adverse event?
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
What is Aesi PV?
As per CIOMS VI, An adverse event of special interest (AESI) (serious or non-serious) is one of scientific and medical concern specific to the sponsor’s product or programme, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.
What are AES of special interest?
According to World Health Organization (WHO), an Adverse Event of Special Interest (AESI) is a pre-identified and predefined medically-significant event that has the potential to be causally associated with a vaccine product that needs to be carefully monitored and confirmed by further special studies.