Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis in Latin America, the International Psoriasis Counc...

Introduction: The primary objective of this study is to assess the knowledge, attitude and awareness adverse drug reaction reporting process among Indian medical undergraduates in a tertiary care teaching hospital. Material Methods: This cross sectional questionnaire based on 250 graduates. Phase III – Part 1 2 Medical Undergraduates at Trichy SRM College Hospital & Research Centre for next 3 m...

Prema definiciji Svetske zdravstvene organizacije farmakovigilanca je nauka ili skup aktivnosti povezanih sa detekcijom, procenom, razumevanjem i prevencijom neželjenih efekata ili bilo kojih drugih problema povezanih sa upotrebom lekova . Pod farmakovigilancom se, generalno, smatralo postmarketinško praćenje neželjenih efekata lekova u četvrtoj fazi kliničkih istraživanja lekova . Međutim, sa ...

INTRODUCTION Targeted spontaneous reporting (TSR) is a pharmacovigilance method that can enhance reporting of adverse drug reactions related to antiretroviral therapy (ART). Minimal data exist on the needs or capacity of facilities to conduct TSR. OBJECTIVES Using data from the International epidemiologic Databases to Evaluate AIDS (IeDEA) Consortium, the present study had two objectives: (1)...

There is always a trade-off involved between the advantages and the possible risk with the use of pharmaceuticals. The risk is minimized when medicines of good quality, safety and efficacy are used rationally by an informed health professional and by patients. Pharmacovigilance helps in reducing the risk of harm by ensuring good quality medicines are used appropriately and expectations and conc...

Biologicals are critical in cancer medicine. Four of the top ten biological blockbusters worldwide are oncology drugs used for therapeutic or supportive care. The global market for biologic cancer therapies approximately totalled US$ 51.2 billion in 2014 and is expected to reach US$ 66.4 billion in 2019. The patents of most of these top-selling agents will expire by the year 2020 attracting ind...

The current state of the art in post-marketing drug surveillance utilizes voluntarily submitted reports of suspected adverse drug reactions. We present data mining methods that transform unstructured patient notes taken by doctors, nurses and other clinicians into a de-identified, temporally ordered, patient-feature matrix using standardized medical terminologies. We demonstrate how to use the ...

Regulators such as the U.S. Food and Drug Administration have elaborate, multi-year processes for approving new drugs as safe and effective. Nonetheless, in recent years, several approved drugs have been withdrawn from the market because of serious and sometimes fatal side effects. We describe statistical methods for post-approval data analysis that attempt to detect drug safety problems as qui...

Since the thalidomide disaster brought the risks of drug events usually refer to general practitioner contacts, outpatient contacts, hospitalization or deaths. This approach therapy into sharp focus, efforts have been made to establish observational systems for early detection of possible adverse was first mooted by Finney in Edinburgh as far back as 1965 [10], but had to await the advent of po...

AIMS Current trends in pharmacovigilance systems are veering towards patient involvement in spontaneous reporting of adverse drug reactions (ADRs). The aim of the current systematic review was to identify what is known and what remains unknown with respect to patient reporting to pharmacovigilance systems. METHODS A systematic literature search was conducted in PubMed, CINAHL, Journals@Ovid a...