: The sheer amount of information about potential adverse drug events published in medical case reports pose major challenges for drug safety experts to perform timely monitoring. Efficient strategies for identification and extraction of information about potential adverse drug events from free-text resources are needed to support pharmacovigilance research and pharmaceutical decision making. T...

BACKGROUND: The "integrated safety report" of the drug registration files submitted to health authorities usually summarizes the rates of adverse events observed for a new drug, placebo or active control drugs by pooling the safety data across the trials. Pooling consists of adding the numbers of events observed in a given treatment group across the trials and dividing the results by the total ...

Information on how drugs are metabolized is not only of importance in understanding their therapeutic action, but can furnish useful clues for the development of new drugs. The various aspects of drug metabolism studies which are considered in this paper are (i) Pathways of drug metabolism— conversion to active, inactive or toxic metabolites; (ii) Structural changes which determine a drug's met...

References 1. Weingert SN, et al. Clinicians’ Assessments of Electronic Medication Safety Alerts in Ambulatory Care. Arch Intern Med 2009; 169: 1627-32. 2. Phansalkar S, et.al. Drug-Drug Interactions That Should be Non-Interruptive in Order to Reduce Alert Fatigue in Electronic Health Records. J Am Med Inform Assoc 2012. Sep 25. An International Evaluation of Drug-Drug Interaction Alerts That S...

The public health community faces increasing demands for improving vaccine safety while simultaneously increasing the number of vaccines available to prevent infectious diseases. The passage of the US Food and Drug Administration (FDA) Amendment Act of 2007 formalized the concept of life-cycle management of the risks and benefits of vaccines, from early clinical development through many years o...

OBJECTIVES Many medication errors can occur when ordering and dispensing medicine in hospitals. The clinical decision support system (CDSS) is widely used in an effort to reduce medication errors. This study focused on the evaluation of user satisfaction with the CDSS for medication at a university hospital. Specifically, this study aimed to identify the factors influencing user satisfaction an...

Unexpected adverse preclinical findings (APFs) are not infrequently encountered during drug development. Such APFs can be functional disturbances such as QT prolongation, morphological toxicity or carcinogenicity. The latter is of particular concern in conjunction with equivocal genotoxicity results. The toxicologic pathologist plays an important role in recognizing these effects, in helping to...

This review highlights general toxicology concerns caused by formulation differences between generic and innovator drugs. It underscores the importance of a scientific, clinically oriented, evidence-based comparative safety evaluation procedure for generic drugs and discusses representative case studies from a pharmacology-toxicology perspective. For consideration by generic drug industry stake...