Results 11 to 20 of about 47,791 (152)

Pharmacovigilance: reporting requirements throughout a product’s lifecycle

Therapeutic Advances in Drug Safety, 2022
Comprehensive methods for evaluating safety are needed to objectively assess the full risk profile of a medication. The confidence of the prescribing provider in the safety and effectiveness of pharmaceuticals is extremely important. Pharmacovigilance is
S. Lucas, J. Ailani, T. Smith, Ahmad M. Abdrabboh, F. Xue, Marco S. Navetta   +5 more
semanticscholar   +1 more source

Pharmacovigilance of Biosimilars [PDF]

, 2013
In lieu of an abstract, here is the article\u27s first paragraph: Biotech industry forms the backbone of the current pharmaceutical products. Seven out of top ten anticipated drugs of the industry in 2014 will be biologics [1].
Chablani, Lipika
core   +2 more sources

Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data

Drug Safety, 2022
Introduction Adverse drug reaction reports are usually manually assessed by pharmacovigilance experts to detect safety signals associated with drugs.
Guillaume L. Martin, Julien Jouganous, Romain Savidan, Axel Bellec, C. Goehrs, M. Benkebil, G. Miremont, J. Micallef, F. Salvo, A. Pariente, L. Létinier   +10 more
semanticscholar   +1 more source

A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators

Therapeutic Innovation and Regulatory Science, 2022
In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing countries’ PV systems’ performance.
Hamza Y. Garashi, D. Steinke, E. Schafheutle   +2 more
semanticscholar   +1 more source

Bayesian model selection in logistic regression for the detection of adverse drug reactions [PDF]

, 2015
Motivation: Spontaneous adverse event reports have a high potential for detecting adverse drug reactions. However, due to their dimension, exploring such databases requires statistical methods.
Marbac, Matthieu, Sedki, Mohammed, Tubert-Bitter, Pascale   +2 more
core   +2 more sources

How pharmacoepidemiology networks can manage distributed analyses to improve replicability and transparency and minimize bias [PDF]

, 2020
Several pharmacoepidemiology networks have been developed over the past decade that use a distributed approach, implementing the same analysis at multiple data sites, to preserve privacy and minimize data sharing.
Brown, Jeffrey S., Henry, David A., Klungel, Olaf H., Platt, Richard, Platt, Robert W., Suissa, Samy   +5 more
core   +2 more sources

Pharmacovigilance in China: Evolution and future challenges

British Journal of Clinical Pharmacology, 2022
Drug‐related adverse reactions are among the main reasons for harm to patients under care worldwide and even their deaths. The pharmacovigilance system has been proven to be an effective method of avoiding or alleviating such adverse events.
Haibo Song, Xiaojing Pei, Zuoxiang Liu, Chuanyong Shen, Jun Sun, Yuqin Liu, Lingyun Zhou, F. Sun, Xiaohe Xiao   +8 more
semanticscholar   +1 more source

Linked health data for pharmacovigilance in children : Perceived legal and ethical issues for stakeholders and data guardians [PDF]

, 2014
Peer reviewedPublisher ...
Bond, Christine M, Francis, Jill J, Haughney, John, Helms, Peter J, Hopf, Yvonne Marina   +4 more
core   +2 more sources

Pharmacovigilance Signals of the Opioid Epidemic over 10 Years: Data Mining Methods in the Analysis of Pharmacovigilance Datasets Collecting Adverse Drug Reactions (ADRs) Reported to EudraVigilance (EV) and the FDA Adverse Event Reporting System (FAERS)

Pharmaceuticals, 2022
In the past twenty years, the consumption of opioid medications has reached significant proportions, leading to a rise in drug misuse and abuse and increased opioid dependence and related fatalities.
S. Chiappini, Rachel Vickers-Smith, A. Guirguis, J. Corkery, G. Martinotti, Daniel R. Harris, F. Schifano   +6 more
semanticscholar   +1 more source

Pharmacists in Pharmacovigilance: Can Increased Diagnostic Opportunity in Community Settings Translate to Better Vigilance? [PDF]

, 2014
The pharmacy profession has undergone substantial change over the last two to three decades. Whilst medicine supply still remains a central function, pharmacist’s roles and responsibilities have become more clinic and patient focused.
AG Granas, AI Wertheimer, B Gray, C Gonzalez-Gonzalez, C Su, Christine Randall, Consumers’ Association, Consumers’ Association, Consumers’ Association, D Brown, D Stewart, David Brown, DM Ashcroft, E Horsley, E Kroger, E Richardson, G Marchildon, GD Lansam, JK Jesson, Justine Howard, K Grootheest van, KB Blake, L Emmerton, L Hanna, M Jadeja, M Rosenthal, M Tobaiqy, MA Hadi, MP Smith, N Black, N Iqbal, P Chan, P Gavaza, P Rutter, Paul Rutter, S Keyhani, SS Sardas, T Kimura, V Paudyal, Z Austin   +39 more
core   +1 more source