PubMed Journals Articles About "Southern Clinical Regulatory" RSS

02:50 EDT 19th October 2018 | BioPortfolio

Southern Clinical Regulatory PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Southern Clinical Regulatory articles that have been published worldwide.

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We have published hundreds of Southern Clinical Regulatory news stories on BioPortfolio along with dozens of Southern Clinical Regulatory Clinical Trials and PubMed Articles about Southern Clinical Regulatory for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Southern Clinical Regulatory Companies in our database. You can also find out about relevant Southern Clinical Regulatory Drugs and Medications on this site too.

Showing "Southern Clinical Regulatory" PubMed Articles 1–25 of 33,000+

Research Misconduct in FDA-Regulated Clinical Trials: A Cross-sectional Analysis of Warning Letters and Disqualification Proceedings.

The US Food and Drug Administration (FDA) ensures that clinical trials meet regulatory and ethical standards through inspections of researchers, also known as clinical investigators. Inspections with significant regulatory/ethical violations may result in regulatory actions, such as a warning letter or a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE). Objectives included the standardization of regulatory violation themes cited by the FDA for novel analysis of publis...

Low HDL-C levels are associated with cervicocerebral atherosclerotic stenosis in Southern Chinese patients with large artery atherosclerotic ischemic stroke.

The aim of this study is to investigate the association of HDL-C with CCAS, as well as its intracranial or extracranial location in the Southern Chinese population.

The North-South divide: substance use risk, care engagement, and viral suppression among hospitalized HIV-infected patients in 11 U.S. cities.

Regional variability in HIV care engagement remains underexplored. Multiple logistic models compared HIV-outcomes for participants from five Southern (n=557) and six Non-Southern sites (n=670). Southern participants had less viral suppression (aOR=0.59; 95%CI=0.43-0.82) and higher likelihood of CD4+

Research Deviations in FDA-Regulated Clinical Trials: A Cross-Sectional Analysis of FDA Inspection Citations.

The US Food and Drug Administration (FDA) ensures clinical trials meet regulatory/ethical standards through inspections. If FDA Investigators observe potential violations of regulatory requirements during an inspection, a firm will receive a Form FDA 483, Inspectional Observations. Violations cited have resulted in the death of human research subjects, prosecution of research personnel, and denial of approval for new medical products. Objectives included the standardization of Violation Themes cited for ana...

Effects of Talaromyces Marneffei Infection on Mortality of HIV/AIDS Patients in Southern China: A Retrospective Cohort Study.

Talaromyces marneffei (TM) is an opportunistic infection with high morbidity among HIV/AIDS patients in Southeast Asia and Southern China. Its effects on mortality in HIV/AIDS patients has not been clearly elucidated.

Pediatric Carbon Monoxide Poisoning in Southern Israel: A Cross-Sectional Study.

This study aimed to describe the epidemiology and clinical burden of unintended carbon monoxide (CO) poisoning among children in the Negev region of southern Israel.

The Near-Term Viability and Benefits of eLabels for Patients, Clinical Sites, and Sponsors.

Current clinical trial labels are designed primarily to meet regulatory requirements. These labels have low patient and site utility, few are opened, and they have limited space and small fonts. As our world transitions from paper to electronic, an opportunity exists to provide patients with information about their investigational clinical trial product in a way that is more easily accessible, meets Health Authority requirements, and provides valuable additional information for the patient and caregiver.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights.

Although randomized controlled clinical trials provide necessary information and serve as the basis for regulatory decision making, a significant gap exists between the evidence these trials provide and what the biomedical community needs. It is recognized that a wealth of data are routinely collected outside clinical trials. Such real-world data (RWD) are not of comparable quality, it does not have similar immunity from bias and confounding as data collected in randomized clinical trials, but it might offe...

Genetic structure and sex-biased gene flow in the history of southern African populations.

We investigated the genetic history of southern African populations with a special focus on their paternal history. We reexamined previous claims that the Y-chromosome haplogroup E1b1b (E-M293) was brought to southern Africa by pastoralists from eastern Africa, and investigated patterns of sex-biased gene flow in southern Africa.

Guidelines for clinical evaluation of chronic kidney disease : AMED research on regulatory science of pharmaceuticals and medical devices.

The Variable Southern Ocean Carbon Sink.

The CO uptake by the Southern Ocean (

How Much Time Do Residents Spend on Inpatient Clinical Computing?

To evaluate the time that residents spend on clinical computing.

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).

Ethnic disparity in breast cancer survival in southern Thai women.

Breast cancer has the highest incidence in women of all cancers and its burden is expected to continue to increase worldwide, especially in middle-income countries such as Thailand. The southern region of Thailand is unique in that it is comprised of 30% Muslims, whereas the rest of Thailand is 95% Buddhist. Breast cancer incidence and survival differ between these religious groups, but the association between clinical subtype of breast cancer and survival has not yet been assessed.

Japan-Specific Key Regulatory Aspects for Development of New Biopharmaceutical Drug Products.

Japan represents the third largest pharmaceutical market in the world. Developing a new biopharmaceutical drug product for the Japanese market is a top business priority for global pharmaceutical companies while aligning with ethical drivers to treat more patients in need. Understanding Japan-specific key regulatory requirements is essential to achieve successful approvals. Understanding the full context of Japan-specific regulatory requirements/expectations is challenging to global pharmaceutical companies...

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...

Clinical and regulatory considerations for novel electrophysiology mapping systems: Lessons from FIRM.

Atrial fibrillation (AF) presents a growing clinical and public health burden for which better rhythm control therapies are needed. Focal impulse and rotor mapping (FIRM), currently marketed as part of the Topera Rotor Mapping system (Abbott Laboratories, Austin, TX), represents a potentially transformational approach to guiding the invasive treatment of AF. However, many years after its initial marketing clearance, the clinical utility of this technology remains uncertain. In this article, we review the sc...

Coexistence of regulatory B cells and regulatory T cells in tumor-infiltrating lymphocyte aggregates is a prognostic factor in patients with breast cancer.

Tumors can acquire tolerance to tumor immunity and develop enhanced proliferation. Regulatory B cells (Bregs), whose role in immune tolerance is similar to that of regulatory T cells (Tregs), appear to be involved in tumor immunity. Recently, Bregs were found to induce Tregs against tumor immunity. However, the platform for the coexistence of Bregs and Tregs in cancer patients and its clinical significance remain unclear; thus, they were evaluated in breast cancer patients.

Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines.

Licensing and decisions on public health use of a vaccine rely on a robust clinical development program that permits a risk-benefit assessment of the product in the target population. Studies undertaken early in clinical development, as well as well-designed pivotal trials, allow for this robust characterization. In 2012, WHO published guidelines on the quality, safety and efficacy of live attenuated dengue tetravalent vaccines. Subsequently, efficacy and longer-term follow-up data have become available fro...

Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities.

Mesenchymal stromal cells (MSCs) have been the subject of clinical trials for more than a generation, and the outcomes of advanced clinical trials have fallen short of expectations raised by encouraging pre-clinical animal data in a wide array of disease models. In this Perspective, important biological and pharmacological disparities in pre-clinical research and human translational studies are highlighted, and analyses of clinical trial failures and recent successes provide a rational pathway to MSC regula...

Dissemination of the Methicillin Resistance Staphylococcus Aureus Pediatric Clone (ST5-T002-IV-PVL+) as a Major Cause of Community Associated Staphylococcal Infections in Bedouin Children, Southern Israel.

Pediatric community associated methicillin resistant Staphylococcus aureus (CA-MRSA) infections are emerging worldwide. High CA-MRSA carriage rates were previously described in healthy Bedouin children. We assessed demographic, clinical and molecular characteristics of pediatric MRSA infections in southern Israel.

A potentially important role for t cells and regulatory t cells in Langerhans cell histiocytosis.

Langerhans cell histiocytosis is characterized by lesions containing inflammatory immune cells, including myeloid cells and T cells. Patient mortality remains unacceptably high and new treatment options are required. Several LCH studies have identified aberrant frequencies of T cell subsets with potential immune regulatory properties. High numbers of Foxp3 regulatory T cells and gamma-delta T cells have been reported in patients with LCH, although, the cause of their presence or their significance is not ye...

Recent Advances in Drug Development and Regulatory Science in China.

As the second largest pharmaceutical market with a great potential for future growth, China has drawn much attention from the global pharmaceutical community. With an increasing government investment in biomedical research, the domestic biopharmaceutical (biotechnological) companies in China are turning their attention to the development of innovative medicines and targeting the global market. To introduce innovative products to Chinese patients sooner, to improve the efficiency of its review and approval p...

From Design to the Clinic: Practical Guidelines for Translating Cardiovascular Nanomedicine.

Cardiovascular diseases (CVD) account for nearly half of all deaths in Europe and almost 30% of global deaths. Despite the improved clinical management, cardiovascular mortality is predicted to rise in the next decades due to the increasing impact of aging, obesity and diabetes. The goal of emerging cardiovascular nanomedicine is to reduce the burden of CVD using nanoscale medical products and devices. However, the development of novel multicomponent nano-sized products poses multiple technical, ethical and...

An outbreak of severe invasive meningococcal disease due to a capsular switched Neisseria meningitidis hypervirulent strain B:cc11.

To investigate an outbreak of invasive meningococcal disease (IMD) in Southern Sardinia.

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