scholarly journals Nanopharmaceutics: Part I—Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU

Pharmaceutics ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 146 ◽  
Author(s):  
Eliana B. Souto ◽  
Gabriela F. Silva ◽  
João Dias-Ferreira ◽  
Aleksandra Zielinska ◽  
Fátima Ventura ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Scale Up ◽  
Intravenous Iron ◽  
Matrix Composition ◽  
Clinical Settings ◽  
The European Union ◽  
Production Methods ◽  
Good Manufacturing Practices ◽  
Copolymer Micelle

The latest advances in pharmaceutical technology are leading to the development of cutting edged approaches to produce what is now known as the “Holy Grail” of medicine—nanopharmaceutics. Over the latest decade, the pharmaceutical industry has made important contributions to the scale up of these new products. To ensure their quality, efficacy, and safety for human use, clinical trials are mandatory. Yet, regulation regarding nanopharmaceuticals is still limited with a set of guidelines being recently released with respect to compliance with quality and safety. For the coming years, updates on regulatory issues about nanopharmaceuticals and their use in clinical settings are expected. The use of nanopharmaceuticals in clinical trials depends on the approval of the production methods and assurance of the quality of the final product by implementation and verification of the good manufacturing practices (GMP). This review addresses the available legislation on nanopharmaceuticals within the European Union (EU), the GMP that should be followed for their production, and the current challenges encountered in clinical trials of these new formulations. The singular properties of nanopharmaceuticals over their bulk counterparts are associated with their size, matrix composition, and surface properties. To understand their relevance, four main clinical trial guidelines, namely, for intravenous iron-based nanopharmaceuticals, liposomal-based nanopharmaceuticals, block copolymer micelle-based nanopharmaceuticals, and related to surface coating requirements, are described here.

scholarly journals Recent Developments in Clinical Applications of Mesenchymal Stem Cells in the Treatment of Rheumatoid Arthritis and Osteoarthritis

2021 ◽  
Vol 12 ◽  
Author(s):  
Joel Jihwan Hwang ◽  
Yeri Alice Rim ◽  
Yoojun Nam ◽  
Ji Hyeon Ju
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Clinical Applications ◽  
Clinical Settings ◽  
Positive Outcomes ◽  
Joint Function ◽  
Safety And Efficacy ◽  
High Expectations ◽  
Recent Developments

Mesenchymal stem cell (MSC) therapies have been used as cell-based treatments for decades, owing to their anti-inflammatory, immunomodulatory, and regenerative properties. With high expectations, many ongoing clinical trials are investigating the safety and efficacy of MSC therapies to treat arthritic diseases. Studies on osteoarthritis (OA) have shown positive clinical outcomes, with improved joint function, pain level, and quality of life. In addition, few clinical MSC trials conducted on rheumatoid arthritis (RA) patients have also displayed some optimistic outlook. The largely positive outcomes in clinical trials without severe side effects establish MSCs as promising tools for arthritis treatment. However, further research is required to investigate its applicability in clinical settings. This review discusses the most recent advances in clinical studies on MSC therapies for OA and RA.

Measuring clinical practice: science and methods

2013 ◽  
Vol 34 (1) ◽  
pp. E3 ◽  
Author(s):  
Peter D. Angevine ◽  
Paul C. McCormick
Keyword(s):  
Clinical Trials ◽  
Clinical Data ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Treatment Options ◽  
Routine Practice ◽  
Clinical Settings ◽  
Clinical Registries ◽  
Basic Understanding

The routine practice of neurosurgery generates a large amount of clinical data. The structured, systematic capture of this information using clinical registries or other rigorously designed observational studies can yield useful evidence to help improve the care of patients. Registries in particular can be designed to measure outcomes in real-world clinical settings and to study differences in outcomes between subgroups. This information can help clinicians to advise patients regarding their treatment options. To provide valid, generalizable evidence, however, registries and other observational studies must be designed and conducted with a rigor similar to that of randomized clinical trials. Neurosurgeons with a basic understanding of the potential advantages and pitfalls of nonrandomized trials and the methods of statistical analysis will be able to assess the quality of clinical data and to incorporate the findings appropriately into their patients' care.

scholarly journals Yield and nutritional quality of greenhouse lettuce (Lactuca sativa L.) as affected by genotype and production methods

Genetika ◽  
2014 ◽  
Vol 46 (3) ◽  
pp. 1027-1036 ◽  
Author(s):  
Aleksandra Govedarica-Lucic ◽  
Mirjana Mojevic ◽  
Goran Perkovic ◽  
Branka Govedarica
Keyword(s):  
Lactuca Sativa ◽  
Nutritional Quality ◽  
Bare Soil ◽  
Production Method ◽  
Nitrate Content ◽  
The European Union ◽  
Production Methods ◽  
Lactuca Sativa L ◽  
Control Variant

Greenhouse experiments were conducted in winter growing seasons in order to evaluate the effects of genotype and production methods on yield and nutritional quality of lettuce (Lactuca sativa L.). A three-year (2009-2011) study was conducted by randomized block system in a greenhouse without additional heating. The trial included three genotypes of lettuce (Archimedes RZ, Santoro RZ, Kibou RZ). Each row with these genotypes was exposed to the following variants of covering: control-planting on bare soil, mulching before sowing with PE-black foil, agro textile-covering plants after planting with agro textile (17 g), a combination of mulching + agro textile. Throughout of all the three years of the trial, it was continuously evidenced that the genotype ?Santoro RZ? had the biggest heads and the highest yield (15.33 kg 10 m-2), which leads to conclusion that the yield of lettuce is a genotype characteristics. Moreover, the nutritional value (ascorbic acid concentration) has shown that, depending on the method of production, in average, the combination of mulching + agro textile (26.77 mg 100 g-1) had the highest content while the control variant had significantly lower vitamin C content (21.10 mg 100 g-1). The three-year researches have shown that the production method and genotype significantly affect the nitrate content. An average nitrate content was 2196.33 mg kg-1 on the control variant, and 2526.24 mg kg-1 on agro textile. Leafy lettuce of genotyp ?Kibou RZ? had lower nitrate content (2176.85 mg kg-1) compared to ?Archimedes RZ? (2843.05 mg kg-1) and ?Santoro RZ? (2221.37 mg kg-1). However nitrate concentration in all treatments remained within the European Union?s permissible levels.

scholarly journals Dietary Interventions with Polyphenols in Osteoarthritis: A Systematic Review Directed from the Preclinical Data to Randomized Clinical Studies

Nutrients ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1420
Author(s):  
Evdokia Valsamidou ◽  
Aristea Gioxari ◽  
Charalampia Amerikanou ◽  
Panagiotis Zoumpoulakis ◽  
George Skarpas ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Synergistic Effects ◽  
Antioxidant Properties ◽  
Research Field ◽  
Clinical Settings ◽  
Dietary Interventions ◽  
Interesting Approach ◽  
Relationship Of

Osteoarthritis (OA) is the most common form of arthritis and a major cause of limited functionality and thus a decrease in the quality of life of the inflicted. Given the fact that the existing pharmacological treatments lack disease-modifying properties and their use entails significant side effects, nutraceuticals with bioactive compounds constitute an interesting field of research. Polyphenols are plant-derived molecules with established anti-inflammatory and antioxidant properties that have been extensively evaluated in clinical settings and preclinical models in OA. As more knowledge is gained in the research field, an interesting approach in the management of OA is the additive and/or synergistic effects that polyphenols may have in an optimized supplement. Therefore, the aim of this review was to summarize the recent literature regarding the use of combined polyphenols in the management of OA. For that purpose, a PubMed literature survey was conducted with a focus on some preclinical osteoarthritis models and randomized clinical trials on patients with osteoarthritis from 2018 to 2021 which have evaluated the effect of combinations of polyphenol-rich extracts and purified polyphenol constituents. Data indicate that combined polyphenols may be promising for the treatment of osteoarthritis in the future, but more clinical trials with novel approaches in the identification of the in-between relationship of such constituents are needed.

Phamacognostical and Pharmaceutical Evaluation of Chandrashakaladi Vataka - A herbal formulation

2016 ◽  
Vol 1 (3) ◽  
Author(s):  
Dr. Akash S Changole ◽  
Mandip Goyal ◽  
Harish CR
Keyword(s):  
Classical Method ◽  
Raw Materials ◽  
Herbal Medicines ◽  
Vital Role ◽  
Published Data ◽  
Herbal Formulation ◽  
Physico Chemical ◽  
Good Manufacturing Practices ◽  
Solvent Systems

Background: Quality control and the standardization of herbal medicines involve steps like standard source and quality of raw materials, good manufacturing practices and adequate analytical screening. These practices play a vital role in guaranting the quality and stability of herbal preparations. Chandrashakaladi Vataka is an Ayurvedic herbal formulation mentioned to be beneficial in Kushtha. Till date no published data is available on its analytical profile. Aim: To develop the Pharmacognostical and Phyto-chemical profile of Chandrashakaladi Vataka. Material and Methods: Chandrashakaladi Vataka was prepared as per classical method and analytical findings were recorded. Samples were subjected to organoleptic analysis, physico-chemical analysis and HPTLC examination by optimizing the solvent systems. Results and Conclusions: Pharmacognostical profile of Chandrashakaladi Vataka was established. Loss on drying, Ash value, Acid insoluble extract, Methanol soluble extract, Chandrashakaladi Vataka was found within prescribed limits. HPTLC profile of Chandrashakaladi Vataka revealed 12 spots at 254 nm and 13 spots at 366 nm.

Prerequisites to support high-quality clinical trials in children and young people

2020 ◽  
pp. archdischild-2019-318677
Author(s):  
Steven Hirschfeld ◽  
Florian B Lagler ◽  
Jenny M Kindblom
Keyword(s):  
Clinical Trials ◽  
Healthcare Delivery ◽  
Paediatric Population ◽  
Ecosystem Functions ◽  
Healthcare Delivery System ◽  
High Quality ◽  
Children And Young People ◽  
The Right ◽  
Support Decision Making

Children have the right to treatment based on the same quality of information that guides treatment in adults. Without the proper evaluation of medicinal products and devices in paediatric clinical trials that are designed to meet the rigorous standards of the competent authorities, children are discriminated from advances in medicine. There are regulatory, scientific and ethical incentives to address the knowledge gap regarding efficacy and safety of medicines in the paediatric population. High-quality clinical trials involving children of all ages can generate data that will ultimately close the knowledge gaps and support decision making.For clinical trials that enrol children, the needs are specialised and often resource intensive. Prerequisites for successful paediatric clinical trials are personnel with training in both paediatrics and neonatology and expertise in clinical trials in these populations. Moreover, national and international networks for efficient collaboration, dissemination of information, and sharing of resources and expertise are also needed, together with competent, efficient and high-quality local infrastructure with effective processes. Monitoring and oversight bodies with the relevant competence, including expertise in paediatrics, is also an important prerequisite for paediatric clinical trials. Compromise in any of these components will compromise the downstream results.This paper discusses the structures and competences needed in order to perform effective, high-quality paediatric clinical trials with the ultimate goal of better medicines and treatments for children. We propose a model of examining the process as a series of components that each has to be optimised, then all the components are actively optimised to function together as an ecosystem, and the resulting ecosystem functions well with the general research system and the healthcare delivery system.

scholarly journals A standardized framework for testing the performance of sleep-tracking technology: step-by-step guidelines and open-source code

SLEEP ◽  
2020 ◽  
Author(s):  
Luca Menghini ◽  
Nicola Cellini ◽  
Aimee Goldstone ◽  
Fiona C Baker ◽  
Massimiliano de Zambotti
Keyword(s):  
Open Source ◽  
Validation Studies ◽  
Large Scale ◽  
Analytical Framework ◽  
Clinical Settings ◽  
Large Scale Data ◽  
Fast Pace ◽  
Epoch Analysis ◽  
Tracking Devices

Abstract Sleep-tracking devices, particularly within the consumer sleep technology (CST) space, are increasingly used in both research and clinical settings, providing new opportunities for large-scale data collection in highly ecological conditions. Due to the fast pace of the CST industry combined with the lack of a standardized framework to evaluate the performance of sleep trackers, their accuracy and reliability in measuring sleep remains largely unknown. Here, we provide a step-by-step analytical framework for evaluating the performance of sleep trackers (including standard actigraphy), as compared with gold-standard polysomnography (PSG) or other reference methods. The analytical guidelines are based on recent recommendations for evaluating and using CST from our group and others (de Zambotti and colleagues; Depner and colleagues), and include raw data organization as well as critical analytical procedures, including discrepancy analysis, Bland–Altman plots, and epoch-by-epoch analysis. Analytical steps are accompanied by open-source R functions (depicted at https://sri-human-sleep.github.io/sleep-trackers-performance/AnalyticalPipeline_v1.0.0.html). In addition, an empirical sample dataset is used to describe and discuss the main outcomes of the proposed pipeline. The guidelines and the accompanying functions are aimed at standardizing the testing of CSTs performance, to not only increase the replicability of validation studies, but also to provide ready-to-use tools to researchers and clinicians. All in all, this work can help to increase the efficiency, interpretation, and quality of validation studies, and to improve the informed adoption of CST in research and clinical settings.

scholarly journals Percutaneous nephrostomy versus retrograde ureteral stenting for acute upper obstructive uropathy: a systematic review and meta-analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ismail Zul Khairul Azwadi ◽  
Mohd Noor Norhayati ◽  
Mohd Shafie Abdullah
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Obstructive Uropathy ◽  
Meta Analysis ◽  
Percutaneous Nephrostomy ◽  
Procedural Pain ◽  
Controlled Trials ◽  
Failure Rates ◽  
Ureteral Stenting

AbstractAcute obstructive uropathy is associated with significant morbidity among patients with any condition that leads to urinary tract obstruction. Immediate urinary diversion is necessary to prevent further damage to the kidneys. In many centres, the two main treatment options include percutaneous nephrostomy (PCN) and retrograde ureteral stenting (RUS). The purpose of this study if to compare the efficacy and safety of PCN and RUS for the treatment of acute obstructive uropathy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL, EMBASE, the World Health Organisation International Clinical Trials Registry Platform and ClinicalTrials.gov. We also searched the reference lists of included studies to identify any additional trials. We included randomised controlled trials and controlled clinical trials comparing the outcomes of clinical improvement (septic parameters), hospitalisation duration, quality of life, urinary-related symptoms, failure rates, post-procedural pain [measured using a visual analogue scale (VAS)] and analgesics use. We conducted statistical analyses using random effects models and expressed the results as risk ratio (RR) and risk difference (RD) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). Seven trials were identified that included 667 patients. Meta-analysis of the data revealed no difference in the two methods in improvement of septic parameters, quality of life, failure rates, post-procedural pain (VAS), or analgesics use. Patients receiving PCN had lower rates of haematuria and dysuria post-operatively and longer hospitalisation duration than those receiving RUS. PCN and RUS are effective for the decompression of an obstructed urinary system, with no significant difference in most outcomes. However, PCN is preferable to RUS because of its reduced impact on the patient’s post-operative quality of life due to haematuria and dysuria, although it is associated with slightly longer hospitalisation duration.

scholarly journals Effect of the Application Date of Fertilizer Containing Silicon and Potassium on the Yield and Technological Quality of Sugar Beet Roots

Plants ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 370
Author(s):  
Arkadiusz Artyszak ◽  
Dariusz Gozdowski ◽  
Alicja Siuda
Keyword(s):  
Sugar Beet ◽  
Foliar Application ◽  
Plant Protection ◽  
Plant Protection Products ◽  
Water Shortage ◽  
The European Union ◽  
Yield Increase ◽  
Time Of Application ◽  
Technological Quality

Water shortage and drought are a growing problem in Europe. Therefore, effective methods for limiting its effects are necessary. At the same time, the “field to fork” strategy adopted by the European Commission aims to achieve a significant reduction in the use of plant protection products and fertilizers in the European Union. In an experiment conducted in 2018–2020, the effect of the method of foliar fertilization containing silicon and potassium on the yield and technological quality of sugar beet roots was assessed. The fertilizer was used in seven combinations, differing in the number and time of application. The best results were obtained by treating plants during drought stress. The better soil moisture for the plants, the smaller the pure sugar yield increase was observed. It is difficult to clearly state which combination of silicon and potassium foliar application is optimal, as their effects do not differ greatly.

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