Post marketing surveillance
A large, multicentre, observational, post-marketing surveillance study of the 2:1 formulation of follitropin alfa and lutropin alfa in routine clinical practice for assisted reproductive technology
... To investigate the characteristics of women who re- ceived the 2:1 formulation of follitropin alfa and lutropin alfa in routine clinical practice in Germany, a 3-year post-marketing surveillance ...
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Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction
... noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of the women who received r-hFSH using the redesigned follitropin alfa ...
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A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records
... From this discussion the necessity is clear for an additional system of EHRs to allow the conducting of drug post-marketing surveillance or other clinical research. First, in EHRs there needs to be a ...
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Post-Marketing Surveillance Study to Assess S-Pantoprazole Induced Clinical Effectiveness (SPICE-Study)
... a post marketing surveillance (PMS) study conducted to assess the safety and efficacy of S-Pantoprazole 20 mg tablets in patients with gastroesophageal reflux disease (GERD) and/or peptic ...
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Post-marketing surveillance data of thrombomodulin alfa: sub-analysis in patients with sepsis-induced disseminated intravascular coagulation
... Thrombomodulin alfa (TM-α; Recomodulin® Injection, Asahi Kasei Pharma Corporation, Tokyo, Japan) is a re- combinant, human, soluble TM possessing an extracellu- lar domain that includes a functional domain. The effects ...
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Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review
... Post-marketing surveillance (PMS) and epidemiology programs are complementary to the pre-market process since they may identify rare serious adverse events due to long-term use of the medical device ...
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Safety and efficacy of Rapamune® (Sirolimus) in kidney transplant recipients: results of a prospective post-marketing surveillance study in Korea
... The present study has some limitations. First, this study was an observational post-marketing surveillance study to satisfy the requirements of the MFDS. The protocol and statistical analysis plan ...
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Long term safety of secukinumab in patients with moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post marketing surveillance data
... and post-authorization safety surveillance has enabled a more comprehensive overview of the safety profile of ...the post-marketing safety surveillance results have not been separated ...
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Safety and Diagnostic Image Quality of Ultravist® in an Unselected Sub Set of Chinese Patients: Data Analyses from a Previous Post Marketing Surveillance
... agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the safety, tolera- bility and diagnostic image quality of ...
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Post marketing surveillance of anti malarial medicines used in Malawi
... The post-marketing surveillance and pharmacovigilance sys- tem has been under development since 2009 and yet, it is still faced with severe ...
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CLINICAL EVALUATION AND POST MARKETING SURVEILLANCE OF MEDICAL DEVICES IN EUROPE
... marketing surveillance plan that it complies with the essential ...The post-marketing surveillance plan shall address the collection and utilization of available information, in ...
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Active post-marketing surveillance of the intralesional administration of human recombinant epidermal growth factor in diabetic foot ulcers
... postmarketing surveillance covered all the Angiology wards that manage DFU in Cuba and some primary care units that have incorporated this drug as part of the dia- betic patients integral care ...
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Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch<sup>® </sup>capsules 2.5 μg) in 3,762 hemodialysis patients with intractable pruritus
... This surveillance found sufficient safety and efficacy of nalfu- rafine as an indication for improvement of intractable pruritus in hemodialysis patients. Regarding the safety profile of this agent, no previously ...
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Post-marketing surveillance study of the safety of dexamethasone intravitreal implant in patients with retinal vein occlusion or noninfectious posterior segment uveitis
... This was a multicenter, 2-year, prospective, observational, post-authorization safety study conducted from March 2012 to March 2016 at 102 sites in France, Germany, Spain, and the UK. The study was carried out in ...
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AN OPEN LABELED, MULTICENTRIC, POST MARKETING SURVEILLANCE (PMS) TO SUBSTANTIATE THE SAFETY AND EFFICACY OF SINAREST SYRUP IN PATIENTS OF COMMON COLD
... They cause 10%-40% of colds.[2] This syndrome affects the upper airways, sometimes in association with low-grade fever and systemic symptoms, and usually presents with at least two of th[r] ...
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Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report
... Patients and methods: Central enrollment method was used to recruit patients diagnosed with BD who were being treated for the first time with lamotrigine to prevent the recurrence/relapse of BD mood episodes. Adverse ...
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Incidence and predictors of hypoglycemia in Japanese patients with type 2 diabetes treated by insulin glargine and oral antidiabetic drugs in real-life: ALOHA post-marketing surveillance study sub-analysis
... Good Post-marketing Study Practice; eGFR: Estimated glomerular filtration rate; FPG: Fasting plasma glucose; HbA1c: Glycosylated hemoglobin; JDS: Japan diabetes society; NNH: Number needed to harm; NPH: ...
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Emergence of unusual human rotavirus strains in Salento, Italy, during 2006–2007
... implemented. Post-marketing surveillance studies are needed to monitor the vaccine impact on circulating strains in order to eval- uate the immunological pressure obtained by vaccination, to identify ...
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Pharmacovigilance System in Bangladesh: A Regulatory Perspective
... conduct post- marketing surveillance activities; Suspected adverse reactions to drugs must be reported using the electronic version of the reporting form available in the fillable pdf on DGDA website ...
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Adverse Drug Reactions of Cardiovascular Drugs in Intensive Cardiac Care Unit in a Tertiary Care Hospital: A Prospective Study
... the limitations on drug safety evaluation in pre- marketing trials and post marketing surveillance and increased usage of cardiovascular drugs made the need for the present study. Hence this ...
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