Risk management plans as a tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe
NS Vermeer, RG Duijnhoven, S Straus… - Clinical …, 2014 - Wiley Online Library
Risk Management Plans (RMPs) have become a cornerstone in the pharmacovigilance of
new drugs in Europe. The RMP was introduced in 2005 to support a proactive approach in …
new drugs in Europe. The RMP was introduced in 2005 to support a proactive approach in …
Opening Pandora's pillbox: using modern information tools to improve drug safety
S Gottlieb - Health Affairs, 2005 - healthaffairs.org
How the Food and Drug Administration (FDA) responds to criticism of its drug safety process
will determine whether drug safety actually improves. Propping up the Office of Drug Safety …
will determine whether drug safety actually improves. Propping up the Office of Drug Safety …
[图书][B] Pharmacovigilance: a practical approach
T Doan, L Scarazzini, C Renz, F Lievano… - 2018 - books.google.com
Written by experts in the field of pharmacovigilance and patient safety, this concise resource
provides a succinct, easy-to-digest overview of an increasingly critical area of medical …
provides a succinct, easy-to-digest overview of an increasingly critical area of medical …
An overview of Canadian and US approaches to drug regulation and responses to postmarket adverse drug reactions
RY Cheung, SH Goodwin - Journal of Diabetes Science and …, 2013 - journals.sagepub.com
Over the years, drug products, including those indicated for diabetes, have been withdrawn
from the marketplace because of quality concerns and/or severe adverse drug reactions …
from the marketplace because of quality concerns and/or severe adverse drug reactions …
The impact of exposure model misspecification on signal detection in prospective pharmacovigilance
RD van Gaalen, M Abrahamowicz… - … and Drug Safety, 2015 - Wiley Online Library
Purpose Pharmacovigilance monitors the safety of drugs after their approval and marketing.
Timely detection of adverse effects is important. The true relationship between time‐varying …
Timely detection of adverse effects is important. The true relationship between time‐varying …
[图书][B] Combining Heterogeneous Databases to Detect Adverse Drug Reactions
Y Li - 2015 - search.proquest.com
Adverse drug reactions (ADRs) cause a global and substantial burden accounting for
considerable mortality, morbidity and extra costs. In the United States, over 770,000 ADR …
considerable mortality, morbidity and extra costs. In the United States, over 770,000 ADR …
[HTML][HTML] Reporting adverse drug events
MH Mayer, SA Dowsett, K Brahmavar… - US …, 2010 - uspharmacist.com
A decision by the FDA to approve a drug for market is based on a thorough review of that
drug's safety and efficacy to determine whether the benefits outweigh the risks associated …
drug's safety and efficacy to determine whether the benefits outweigh the risks associated …
Utilizing drug-target-event relationships to unveil safety patterns in pharmacovigilance
Introduction Signal detection is the most pivotal activity of signal management to guarantee
that drugs maintain a positive risk-benefit ratio during their lifetime on the market. Signal …
that drugs maintain a positive risk-benefit ratio during their lifetime on the market. Signal …
[HTML][HTML] Pharmacovigilance 2030: Invited commentary for the January 2020 “Futures” edition of clinical pharmacology and therapeutics
P Arlett, S Straus, G Rasi - Clinical pharmacology and therapeutics, 2020 - ncbi.nlm.nih.gov
Pharmacovigilance systems around the world have come a long way in the last 60 years.
Systems have evolved from reliance on the individual case safety report (ICSR) of suspected …
Systems have evolved from reliance on the individual case safety report (ICSR) of suspected …
With regard to the paper by Zannad et al. entitled Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment versus risk …
JR Turner, DR Karnad, S Kothari, A Metz… - European Heart …, 2017 - academic.oup.com
We are writing to commend Zannad et al. 1 on their excellent paper. In recent years,
guidance from both the US Food and Drug Administration (FDA) 2 and the European …
guidance from both the US Food and Drug Administration (FDA) 2 and the European …