Comparative observational studies- Case control study is one of the type of Comparative observational studies. CASE-CONTROL STUDIES In contrast with cohort and cross sectional studies, case control studies are usually retrospective. People with the outcome of interest are matched with […]
Cohort, cross sectional, and case-control studies are often referred to as observational studies because the investigator simply observes. No interventions are carried out by the investigator. With the recent emphasis on evidence based medicine and the formation of the Cochrane […]
Pharmacovigilance Methods Active Surveillance Active surveillance, in contrast to passive surveillance, pursues to determine the particular number of adverse events through a constant pre-organized process. In common, it is more achievable to acquire wide-ranging data on discrete adverse event reports […]
I. Passive surveillance • Encompasses all spontaneous AEFI reporting • from immunization service providers / hospitals / patients •Up to next levels: state/territory then national (TGA) and then global a) Spontaneous reports A spontaneous report is a voluntary communication by […]
Pharmacovigilance Methods Objective: To establish a functional reporting system to monitor the safety of all medicines To learn more about the safety profile of new medicines in the early post-marketing phase To learn more about the ADR profile of a […]
Overview Under recommended conditions, all vaccines used in national immunization programmes are safe and effective if used correctly. In practice, however, no vaccine is completely risk-free and adverse events can occasionally result after an immunization. Adverse events can range from […]
Safety and efficacy are the two major concerns about any drug. While the efficacy of a drug can be detected with relative ease, the same cannot be said about safety because the adverse effect of a drug may be uncommon […]
Establishing Pharmacovigilance Center in Hospital THE NEED The human safety data extrapolated from animal studies are often deviant in many aspects and not conclusively predictive. Although surface clinical trials reveal a fair percentage of ADRs, but they may not always […]
Pharmacovigilance Programme of India (PvPI) The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services under the aegis of Ministry of Health & Family Welfare, Government of India in association with Indian Pharmacopeia commission, Ghaziabad is initiating a […]
Pharmacovigilance has been defined by the WHO (2002) as the ‘science and activities relating to the detection, assessment, understanding and prevention of adverse effect or any other drug related problems.’ The information generated by pham1acovigilance is useful in educating doctors […]