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PubMed Journals Articles About "Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)" RSS

14:33 EST 14th December 2018 | BioPortfolio

Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan) PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan) articles that have been published worldwide.

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Showing "Zithromax Special Investigation Regulatory Post Marketing Commitment Plan" PubMed Articles 1–25 of 16,000+

A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA.

In this study we compared Swissmedic's (SMC's) regulatory marketing authorization decisions to those of the US Food and Drug Administration (FDA) and European drug regulatory authorities (EU). We investigated the overall similarity of the regulatory decisions, approval, and postmarketing withdrawal rates in the 3 jurisdictions. In case regulatory decisions diverged, we analyzed the reasons for rejection of marketing authorization applications (MAAs).


Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs.

In 1992, the Food and Drug Administration (FDA) instituted the accelerated approval regulations that allow drugs or biologics for serious conditions that fill an unmet medical need to be approved on the basis of a surrogate endpoint or an intermediate clinical endpoint. The current definition of a serious condition includes chronic disabling conditions, such as osteoarthritis (OA), and thereby provides expanded opportunities for the use of biomarkers for regulatory approval of drugs for OA. The use of surro...

Lacosamide efficacy and tolerability in clinical practice - Post marketing analysis from a single dedicated epilepsy center.

Post marketing analysis of anti-epileptic drug (AED) efficacy and tolerability is of great value to the clinician since it is more representative of clinical practice than clinical trial data. We analyzed our experience with lacosamide (LCM) in patients treated after marketing.


Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study.

In recent years, several biosimilar drugs, including those of infliximab, have obtained marketing authorization from the European Medicines Agency (EMA). Given the peculiarity of the safety profile of biological medical products (originator and biosimilars), the evaluation of their tolerability represents an important component of pre-marketing and post-marketing clinical development. For example, infliximab products may cause adverse drug reactions (ADRs) including acute infusion reactions, delayed hyperse...

Quality control programmes for veterinary antimicrobial medicines.

The health benefits of the antimicrobial's use is inherently associated to the risk of antimicrobial resistance (AMR), an ever-increasing multifactorial problem, closely related with injudicious use of antimicrobials, and the lack of new antimicrobial medicines on the market, particularly for veterinary use. Currently, an increasing number of regulatory "One Health" action plans on AMR are running worldwide, already based on monitoring and surveillance systems for resistance and antimicrobials consumption. ...

The Lulun Project's social marketing strategy in a trial to introduce eggs during complementary feeding in Ecuador.

The Lulun Project incorporated a social marketing strategy that accompanied a randomized controlled trial (RCT) of a food-based intervention that introduced eggs into the complementary feeding diet of Ecuadorian infants. This strategy was designed to promote behaviour change, in this case, egg consumption, through voluntary prosocial behaviour, empowerment, and brand loyalty. A three-phase social marketing strategy (design, campaigns, and evaluation) contributed to our successful RTC by applying techniques ...

Safety and effectiveness of istradefylline in patients with Parkinson's disease: interim analysis of a post-marketing surveillance study in Japan.

Istradefylline is a first-in-class, non-dopaminergic, selective adenosine A receptor antagonist for the treatment of Parkinson's disease (PD) in patients experiencing the wearing-off phenomenon with levodopa (L-DOPA). The authors present an interim report from a post-marketing surveillance (PMS) evaluating the safety and effectiveness of long-term istradefylline in a real-world setting.

Real-world use of sunitinib in Japanese patients with pancreatic neuroendocrine tumors: results from a post-marketing surveillance study.

Sunitinib is approved for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNETs) in patients with unresectable, locally advanced or metastatic disease. Safety and efficacy data in Japanese patients are limited. We report outcomes from a post-marketing surveillance study of sunitinib treatment in Japanese patients.

The magnitude and impact of tobacco marketing exposure in adolescents' day-to-day lives: An ecological momentary assessment (EMA) study.

Research indicates that tobacco marketing contributes to higher pro-tobacco attitudes and behaviors among adolescents, but no studies have been able to assess the impact of real-world tobacco marketing exposures in real-time. The purpose of this study was to examine the magnitude and impact of tobacco marketing exposure on adolescents using ecological momentary assessment (EMA). Our primary hypotheses were that (1) youth would most frequently report tobacco marketing at the retail points-of-sale and (2) gre...

General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device. Final order.

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify the needle destruction device, renaming the device to "sharps needle destruction device, a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassi...

Safety and effectiveness of eculizumab for adult patients with atypical hemolytic-uremic syndrome in Japan: interim analysis of post-marketing surveillance.

Eculizumab has been available for the treatment of atypical hemolytic-uremic syndrome (aHUS) in Japan since 2013. To assess safety and effectiveness of eculizumab in adult aHUS patients in the real-life setting, we performed interim analysis of a post-marketing surveillance mandated by Japanese regulations.

Commitment and community participation towards health: knowledge creation from the systematization of social experiences.

Objective. To reflect on the process of committing to participation in the implementation of a health strategic plan, using Participative Systematization of Social Experiences as a tool.

Acceptance and Commitment Therapy for Prevention of Chronic Post-surgical Pain and Opioid Use in At-Risk Veterans: A Pilot Randomized Controlled Study.

High levels of pain, significant anxiety, and/or depressive symptoms prior to surgery put patients at elevated risk forchronic pain and prolonged opioid use following surgery. The purpose of this preliminary study was to assess the efficacy of a one-day Acceptance and Commitment Therapy (ACT) workshop in "at-risk" Veterans for the prevention of chronic pain and opioid use following orthopedic surgery. In a randomized controlled trial, 88 at-risk Veterans undergoing orthopedic surgery were assigned to Treatm...

Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway.

In the USA, drugs are approved by the FDA by three main regulatory pathways: (i) 505(b)(1) new drug applications (NDAs); (ii) 505(b)(2) NDAs; and (iii) 505(j) abbreviated NDAs (ANDAs). The appropriate pathway depends on the active ingredient, already approved drug products, drug formulation, clinical indication, route of exposure, among other factors. The 505(b)(2) NDA pathway is a regulatory approval pathway that allows sponsors to use existing public data in lieu of conducting studies; thus, potentially o...

Pharmacodynamic analysis of eribulin safety in breast cancer patients using real-world post-marketing surveillance data.

Post-marketing surveillance is useful to collect safety data in real-world clinical settings. In this study, we firstly applied the post-marketing real-world data on a mechanistic model analysis for neutropenic profiles of eribulin in patients with recurrent or metastatic breast cancer (RBC/MBC). Demographic and safety data were collected using an active surveillance method from eribulin-treated RBC/MBC patients. Changes in neutrophil counts over time were analyzed using a mechanistic pharmacodynamic model....

Relationship of Eating Patterns and Metabolic Parameters, and Teneligliptin Treatment: Interim Results from Post-marketing Surveillance in Japanese Type 2 Diabetes Patients.

Healthy eating is a critical aspect of the prevention and management of type 2 diabetes (T2DM). Disrupted eating patterns can result in poor glucose control and increase the likelihood of diabetic complications. Teneligliptin inhibits dipeptidyl peptidase-4 activity for 24 h and suppresses postprandial hyperglycemia after all three daily meals. This interim analysis of data from the large-scale post-marketing surveillance of teneligliptin (RUBY) in Japan examined eating patterns and their relationship with...

Using real world data to extrapolate evidence from randomized controlled trials.

Randomized controlled trials provide evidence for regulatory agencies, shape clinical practice, influence formulary decisions and have important implications for patients. However, many patient groups that are major consumers of drugs are underrepresented in randomized trials. We review 3 methods to extrapolate evidence from trial participants to different target populations following market approval and discuss how these could be implemented in practice to support regulatory and health technology assessmen...

The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?

Enormous progress has been made globally in the use of evidence derived from patients' clinical information as they access their routine medical care. The value of real-world data lies in their complementary nature compared with data from randomised controlled trials: less detailed information on drug efficacy but longer observational periods and larger, more heterogeneous study populations reflecting clinical practice because individuals are included who would not usually be recruited in trials. Real-world...

Contemporary Aspects of Marketing in Clinical Trials Including Segments of IT and Technology Transfer.

The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies.

Safety and performance of current abuse deterrent formulations.

Prescription opioid abuse is now an epidemic that has forced the government and industries to take initiatives. These include developing abuse-deterrent formulations (ADFs), issuing regulatory guidances, and allocating massive budgets to ensure the of safety and effectiveness of these medications. Areas covered: This review covers the regulatory guidance on evaluation and labeling of the branded and generic ADFs. It also includes the relevant patents and technologies, the in-vitro, in-vivo, the post-marketi...

Global Development of Anticancer Therapies for Rare Cancers, Pediatric Cancers, and Molecular Subtypes of Common Cancers.

Advances in genetic sequencing and other diagnostic technologies have enabled the use of precision medicine in clinical cancer care, as well as the development of novel therapies that are targeted to specific molecular drivers of cancer. Developing these new agents and making them accessible to patients requires global clinical studies and regulatory review and approval by different national regulatory agencies. Whereas these global trials present challenges for drug developers who conduct them and regulato...

Conserved regulatory state expression controlled by divergent developmental gene regulatory networks in echinoids.

Evolution of the animal body plan is driven by changes in developmental gene regulatory networks (GRNs), but how networks change to control novel developmental phenotypes remains in most cases unresolved. Here we address GRN evolution by comparing the endomesoderm GRN in two echinoid sea urchins, and , with at least 268 million years of independent evolution. We first analyzed the expression of twelve transcription factors and signaling molecules of the GRN in embryos, showing that orthologous regulatory...

Strengthening Health Products Regulatory Systems to Enhance Access to Quality Health Products in the Asia-Pacific.

Asia-Pacific is a region of fast growing opportunity for biomedical research and marketing of new health products by pharmaceutical and medical device companies. While national regulatory authorities have the responsibility to ensure timely access to innovative, effective, and safe therapies, many face capacity and resource constraints that limit their ability to guarantee a robust regulatory system capable of licensing and monitoring novel medicines and medical devices, and tackling substandard and falsifi...

First-year success in a nursing baccalaureate plan of study: A descriptive research study.

Predicting students' aptitude for post-secondary success remains a widely studied topic. This descriptive study explored demographic variables contributing to success in quantitative courses required by the nursing degree plan. Identification of an "at risk" student profile may inform interventions with which to support attainment of an academic degree.

Children's home and school neighbourhood exposure to alcohol marketing: Using wearable camera and GPS data to directly examine the link between retailer availability and visual exposure to marketing.

Neighbourhood alcohol availability has been associated with alcohol consumption by children, despite children rarely acquiring alcohol from retailers. This study explores one potential reason for this finding, by evaluating the relationships between neighbourhood alcohol availability and children's actual exposure to alcohol marketing.


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