Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices.

abstract：:Childhood hyperactivity is a common behavioural complaint. The therapeutic options for physicians caring for children with hyperactivity are considerable and varied; current recommendations call for a multidisciplinary approach, including when necessary the use of drug therapy. Central nervous system stimulants are th...

journal_title：Drug safety

authors： Fox AM,Rieder MJ

更新日期：1993-07-01 00:00:00

abstract：:The complications of failure, neural injury and local anaesthetic toxicity are common to all regional anaesthesia techniques, and individual techniques are associated with specific complications. All potential candidates for regional anaesthesia should be thoroughly evaluated and informed of potential complications. I...

journal_title：Drug safety

authors： Faccenda KA,Finucane BT

更新日期：2001-01-01 00:00:00

abstract：:The mitochondrial respiratory chain (MRC) and ATP synthase (complex V) play an essential role in cellular energy production by the process of oxidative phosphorylation. In addition to inborn errors of metabolism, as well as secondary causes from disease pathophysiology, an impairment of oxidative phosphorylation can r...

journal_title：Drug safety

authors： Hargreaves IP,Al Shahrani M,Wainwright L,Heales SJ

更新日期：2016-07-01 00:00:00

abstract：:It has been more than 25 years since an adverse drug reaction (ADR) monitoring agency was first established in China. In the past few years, the National ADR Monitoring System (NADRMS) has developed rapidly in the country. However, this system has not been reviewed in detail in the literature. Our aim was to demonstra...

journal_title：Drug safety

authors： Hou Y,Li X,Wu G,Ye X

更新日期：2016-11-01 00:00:00

abstract：BACKGROUND:The detection of new drug safety signals is of growing importance with ever more new drugs becoming available and exposure to medicines increasing. The task of evaluating information relating to safety lies with national agencies and, for international data, with the World Health Organization Programme for I...

journal_title：Drug safety

authors： Lindquist M,Ståhl M,Bate A,Edwards IR,Meyboom RH

更新日期：2000-12-01 00:00:00

abstract：:Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs ...

journal_title：Drug safety

authors： Inokuma Y

更新日期：2017-06-01 00:00:00

abstract：:Although the aetiology of inflammatory bowel disease remains elusive, many agents are available for the control of symptoms and inflammation. Knowledge of drug pharmacology, indications and side effects is essential to ensure the best possible clinical care while minimising toxicity and inappropriate use. Sulfasalazin...

journal_title：Drug safety

authors： Hanauer SB,Stathopoulos G

更新日期：1991-05-01 00:00:00

abstract：BACKGROUND:Acute liver failure is idiopathic and drug-related in, respectively, around 50 and 15 % of children. Population-based, epidemiologic data about the pattern of disease manifestation and incidence of less severe acute liver injury, either idiopathic or potentially drug-attributed are limited in children and ad...

journal_title：Drug safety

authors： Ferrajolo C,Verhamme KM,Trifirò G,'t Jong GW,Giaquinto C,Picelli G,Oteri A,de Bie S,Valkhoff VE,Schuemie MJ,Mazzaglia G,Cricelli C,Rossi F,Capuano A,Sturkenboom MC

更新日期：2013-10-01 00:00:00

abstract：:The development of antiretroviral therapy (ART) has dramatically increased the lifespan of HIV patients but treatment is complicated by numerous adverse effects and toxicities. ART complications include neuropsychiatric, metabolic, gastrointestinal, cardiac, and numerous other toxicities, and clinicians often have to ...

journal_title：Drug safety

authors： Treisman GJ,Soudry O

更新日期：2016-10-01 00:00:00

abstract：:The prevalence and incidence of adverse drug interactions involving nonsteroidal anti-inflammatory drugs (NSAIDs) remains unknown. To identify those proposed drug interactions of greatest clinical significance, it is appropriate to focus on interactions between commonly used and/or commonly coprescribed drugs, interac...

journal_title：Drug safety

authors： Johnson AG,Seideman P,Day RO

更新日期：1993-02-01 00:00:00

abstract：:Women who discover they are pregnant after exposure to a drug and pregnant women who have a condition that requires continued treatment during pregnancy are told to balance the benefits and risks of the exposure to justify continuation of treatment, discontinuation of treatment or, possibly, pregnancy termination. How...

journal_title：Drug safety

authors： Shields KE,Wiholm BE,Hostelley LS,Striano LF,Arena SR,Sharrar RG

更新日期：2004-01-01 00:00:00

abstract：:The prognosis is generally poor for patients who experience a cardiac arrest. The most common causes of sudden cardiac arrest are massive pulmonary embolism (PE) and acute myocardial infarction (MI). While thrombolysis is a first-line treatment option in massive PE and acute MI, cardiopulmonary resuscitation (CPR) has...

journal_title：Drug safety

authors： Spöhr F,Böttiger BW

更新日期：2003-01-01 00:00:00

abstract：:The purpose of this review is to assess the benefits and risks associated with the use of the ketolide antibacterial telithromycin, currently licensed for the treatment of adults with mild to moderate community-acquired pneumonia (CAP). Telithromycin is active against both the major (Streptococcus pneumoniae, Haemophi...

journal_title：Drug safety

authors： Brown SD

更新日期：2008-01-01 00:00:00

abstract：:Quinolones are a class of antibacterial agents for the treatment of several infectious diseases (e.g. urinary and respiratory tract infections). They are used worldwide due to their broad spectrum of activity, high bioavailability and good safety profile. The safety profile varies from quinolone to quinolone. The aim ...

journal_title：Drug safety

authors： Tomé AM,Filipe A

更新日期：2011-06-01 00:00:00

abstract：INTRODUCTION:Real-world data on the comparative effectiveness and safety of switching among different epoetins (including originators and biosimilars) are limited. In light of current debate about interchangeability, prescribers, some patient groups and decision makers are calling for additional post-marketing evidence...

journal_title：Drug safety

authors： Belleudi V,Trotta F,Addis A,Ingrasciotta Y,Ientile V,Tari M,Gini R,Pastorello M,Scondotto S,Cananzi P,Traversa G,Davoli M,Trifirò G,Italian Biosimilar Network (ItaBioNet).

更新日期：2019-12-01 00:00:00

abstract：BACKGROUND:The case-population approach or population-based case-cohort approach is derived from the case-control design and consists of comparing past exposure to a given risk factor in subjects presenting a given disease or symptom (cases) with the exposure rate to this factor in the whole cohort or in the source pop...

journal_title：Drug safety

authors： Théophile H,Laporte JR,Moore N,Martin KL,Bégaud B

更新日期：2011-10-01 00:00:00

abstract：BACKGROUND:Spontaneous reporting of adverse drug reactions (ADRs) is fundamental to drug safety surveillance (pharmacovigilance); however, substantial under-reporting exists and is the main limitation of the system. Several factors could favour under-reporting. OBJECTIVE:The aim of this pilot study was to assess the e...

journal_title：Drug safety

authors： Gony M,Badie K,Sommet A,Jacquot J,Baudrin D,Gauthier P,Montastruc JL,Bagheri H

更新日期：2010-05-01 00:00:00

abstract：BACKGROUND:Rituximab is a monoclonal antibody approved for treating CD20-positive B-cell non-Hodgkin's lymphoma and rheumatoid arthritis but is used off-label for treating many autoimmune disorders, including multiple sclerosis (MS). Similarly to other monoclonal antibodies, the incidence of infusion-related reactions ...

journal_title：Drug safety

authors： Brown BA,Torabi M

更新日期：2011-02-01 00:00:00

abstract：INTRODUCTION:There are few studies assessing how data on adverse drug events from consumers on social media compare with other sources. AIM:The aim of this study was to assess the consistency of adverse event data of statin medications from social media as compared with other sources. METHODS:We collected data on the...

journal_title：Drug safety

authors： Golder S,Smith K,O'Connor K,Gross R,Hennessy S,Gonzalez-Hernandez G

更新日期：2021-02-01 00:00:00

abstract：:Current key challenges and controversies encountered in the identification of potentially hepatotoxic drugs and the assessment of drug-induced liver injury (DILI) are covered in this article. There is substantial debate over the classification of DILI itself, including the definition and validity of terms such as 'int...

journal_title：Drug safety

authors： Corsini A,Ganey P,Ju C,Kaplowitz N,Pessayre D,Roth R,Watkins PB,Albassam M,Liu B,Stancic S,Suter L,Bortolini M

更新日期：2012-12-01 00:00:00

abstract：BACKGROUND:Several efforts are under way to develop and test methods for prospective drug safety monitoring using large, electronic claims databases. Prospective monitoring systems must incorporate signalling algorithms and techniques to mitigate confounding in order to minimize false positive and false negative signal...

journal_title：Drug safety

authors： Wahl PM,Gagne JJ,Wasser TE,Eisenberg DF,Rodgers JK,Daniel GW,Wilson M,Schneeweiss S,Rassen JA,Patrick AR,Avorn J,Bohn RL

更新日期：2012-05-01 00:00:00

abstract：:After initial enthusiasm, the use of monoamine oxidase inhibitors (MAOIs) has been limited by the wide range of MAOI-drug and MAOI-food interactions that are possible, particularly with sympathomimetic medications or tyramine-containing foods, resulting in hypertensive reactions. Despite their clinical benefits, this ...

journal_title：Drug safety

authors： Livingston MG,Livingston HM

更新日期：1996-04-01 00:00:00

abstract：INTRODUCTION:The use of mobile apps is increasing in medicine. In pharmacovigilance, mobile apps may help to increase adverse drug reaction reporting and improve the communication of safety issues. The Toulouse University Pharmacovigilance Center has developed VigiBIP®, a free smartphone app available on Android and Ap...

journal_title：Drug safety

authors： Montastruc F,Bagheri H,Lacroix I,Damase-Michel C,Chebane L,Rousseau V,Jouanjus E,Lapeyre-Mestre M,Durrieu G,Montastruc JL

更新日期：2018-05-01 00:00:00

abstract：:Rhythm control in atrial fibrillation (AF) can be achieved using pharmacological therapy. Amiodarone is the most efficacious anti-arrhythmic agent; however, its use is limited due to an unfavourable safety profile, including pro-arrhythmia, thyroid, liver, skin and pulmonary complications. Dronedarone, which is struct...

journal_title：Drug safety

authors： Adlan AM,Lip GY

更新日期：2013-02-01 00:00:00

abstract：INTRODUCTION:Adverse drug events (ADEs) may represent an important item of expenditure for healthcare systems and their prevention could be associated with a relevant cost saving. OBJECTIVE:The objective of this study was to simulate the annual economic burden for ADEs in Tuscany (Italy) and the potential cost savings...

journal_title：Drug safety

authors： Convertino I,Salvadori S,Pecori A,Galiulo MT,Ferraro S,Parrilli M,Corona T,Turchetti G,Blandizzi C,Tuccori M

更新日期：2019-03-01 00:00:00

abstract：BACKGROUND:Over-the-counter analgesics (OTCAs), principally paracetamol (acetaminophen)-containing compounds and NSAIDs, are commonly used medications. Guidelines for the use of these agents in patients with chronic liver disease (CLD) are not available, despite the possibility that such patients may be more susceptibl...

journal_title：Drug safety

authors： Rossi S,Assis DN,Awsare M,Brunner M,Skole K,Rai J,Andrel J,Herrine SK,Reddy RK,Navarro VJ

更新日期：2008-01-01 00:00:00

abstract：OBJECTIVES:Difficulty sleeping is a recognised tobacco withdrawal symptom, but sleep problems, like application site reactions, are commonly reported as adverse reactions to transdermal nicotine therapy. However, no studies have examined potential predictive factors associated with the occurrence of expected adverse ex...

journal_title：Drug safety

authors： Gourlay SG,Forbes A,Marriner T,McNeil JJ

更新日期：1999-06-01 00:00:00

abstract：:Drug interactions in patients receiving multiple drug regimens are a constant concern for the clinician. With the increased availability of new drugs and their concomitant use with other drugs, there has been a rise in the potential for adverse drug interactions as demonstrated by the recent withdrawals of newly marke...

journal_title：Drug safety

authors： Kuhlmann J,Mück W

更新日期：2001-01-01 00:00:00

abstract：:Propofol (2, 6-diisopropylphenol) is a potent intravenous hypnotic agent that is widely used in adults and children for sedation and the induction and maintenance of anaesthesia. Propofol has gained popularity for its rapid onset and rapid recovery even after prolonged use, and for the neuroprotection conferred. Howev...

journal_title：Drug safety

authors： Fodale V,La Monaca E

更新日期：2008-01-01 00:00:00

abstract：BACKGROUND:Newly approved drugs, in comparison with older drugs, are more often prescribed to patients who have not responded satisfactorily to established related drugs or as first-line therapy to patients with a high baseline risk for adverse outcomes (i.e. channelling). However, these patients are less likely to ben...

journal_title：Drug safety

authors： Layton D,Souverein PC,Heerdink ER,Shakir SA,Egberts AC

更新日期：2008-01-01 00:00:00