Some of the terms used in drug safety can vary in how the terminologies are interpreted and used. For instance:
Adverse Drug Reaction
In the pre-approval of the drugs’ clinical experience with a fresh medicinal product or its usages, specifically as the therapeutic dose or doses might not be established, all unintended and noxious responses to the medicinal product associate with any of the does should be considered as the adverse drug reaction.
An adverse event or AE can be any unintended and unfavourable sign, including the abnormal laboratory finding, symptom or the disease temporarily related to the medicinal product’s use whether or not considered associated with the medicinal product.
Assessment of the favourable or beneficial and unfavourable outcomes of undertaking a particular course of action the medicinal action can contribute to the final evaluation of the perks of the drugs.
Causal relationship or assessment is the method for assigning the probability of the causation to a suspended adverse reaction of the drug.
Clinical trial or study is the investigation into the human subjects that is intended with the purpose to verify or discover the pharmacological, clinical or pharmacodynamics of an investigational product or to identify any of the adverse reactions of the investigational product.
Control group or cohort studies usually identify and compare the exposed patients to the unexposed patients or to the patients that receive different exposure from the use of the drug.
Dechallenge and Rechallenge
Dechallenge refers to the stopping of the drug generally after the adverse event or at the termination of the planned treatment. Rechallenge refers to the re-commencement of the similar drug after its usage has been stopped generally for adverse event.
The effectiveness of drugs examines the trends in the disease events over the time across the various geographical locations and then correlates them with the trends in the putative exposures like the rates of the utilisation of drug.
Efficacy is concerned with the conduct, design, and safety and reporting of the clinical trials of the drug. It also encompasses the novel kinds of the medicines derived from the biotechnological procedures.
It is considered vital while testing the effect of the new drug in the market that all the events occur after its use is reported to the clinics.
The drug use in the sector of Pharmacovigilance is tested before launching it in the market so that the users do not suffer any harm, however if the users experience any they should stop its usage and report to the clinic.
Implied causality refers to the spontaneously reported adverse even cases where the causality is always presumed to in positive sense unless the reports of the event states otherwise.
Individual case study report
Individual case study report in Pharmacovigilance is part of the adverse event reporting. It includes serious as well as unlisted events that are considered associated with the use of the drug by the individual.
Life threatening refers to the adverse event or AE that places the patient at the instant risk of death due to the usage of the new drug.
The drugs introduced by the company are tested on the humans on the basis of the phases or level, where the affect of the drug is examined after its intake the patient.
Signal detection or SD includes a range of many techniques to detect the affects of the drug on the patient.