Guidelines for good database selection and use in pharmacoepidemiology research

Guidelines for good database selection and use in pharmacoepidemiology research.

The use of healthcare databases in research provides advantages such as increased speed, lower costs and limitation of some biases. However, database research has its own challenges as studies must be performed within the limitations of resources, which often are the product of complex healthcare systems. The primary purpose of this document is to assist in the selection and use of data resourc...

Guidelines for good pharmacoepidemiology practices (GPP).

Pharmacoepidemiologic studies provide valuable information about the health effects of healthcare products. The ISPE Guidelines for Good Pharmacoepidemiology Practices (GPP) are intended to assist investigators with issues pertaining to the planning, conduct, and evaluation of pharmacoepidemiologic research. The first revision, in 2004 revised and superseded the Guidelines for Good Epidemiologi...

Use of a German longitudinal prescription database (LRx) in pharmacoepidemiology

Large epidemiological databases are often used to examine matters pertaining to drug utilization, health services, and drug safety. The major strength of such databases is that they include large sample sizes, which allow precise estimates to be made. The IMS® LRx database has in recent years been used as a data source for epidemiological research. The aim of this paper is to review a number of...

Draft Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiology Assessment

Draft Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiology Assessment