Search results for "Food and drug administration"
showing 10 items of 24 documents
Nanotechnologies for Active and Intelligent Food Packaging: Opportunities and Risks
2017
This chapter focuses on providing a comprehensive review on the current development of nanotechnology in the field of active and intelligent packaging for food. Systems devoted to intelligent food packaging require easy-to-read, cheap, robust, and safe systems that are able to provide on time information. Food and Drug Administration (FDA) considers that evaluations of safety, effectiveness, public health impact, or regulatory status of nanotechnology products should consider any unique properties and behaviors that the application of nanotechnology may impart. The lack of regulatory support providing standardized risk assessments of engineered nanomaterials (ENM) through integration of haz…
Validation of STA-Liatest D-Di assay for exclusion of pulmonary embolism according to the latest Clinical and Laboratory Standard Institute/Food and …
2017
: Combined clinical pretest probability (PTP) and D-dimer testing have great diagnostic value for pulmonary embolism exclusion. To harmonize performance levels of D-dimer assays available on the market, the Clinical and Laboratory Standard Institute (CLSI) has published a guideline, endorsed by the US Food and Drug Administration (FDA). Such guideline specifies the ideal D-dimer assay characteristic and target population. This study was conducted following the CLSI guideline to upgrade the assay-intended use and obtain FDA clearance of STA-Liatest D-Di assay for pulmonary embolism exclusion in patient with low/moderate PTP. This was an international, multicenter, prospective nonrandomized, …
Clinical trials with a new atypical antipsychotic (Aripiprazole): gender specific information analysis.
2008
In 1993, the Food and Drug Administration (FDA) published a guideline for the study and evaluation of gender-related differences in clinical trials. However, the extent of the implementation of these recommendations has not been systematically reviewed.To determine the proportion of women in clinical trials of Aripiprazole, a new atypical antipsychotic, and to analyze the resulting information on a gender-specific basis.A systematic review was conducted in Medline to identify randomized trials that compared this new antipsychotic drug with placebo or with typical or atypical antipsychotics in patients diagnosed with schizophrenia. The FDA Guideline was followed for the study and evaluation …
Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly …
2016
Michele Fornaro,1,2 Marco Solmi,3–5 Giampaolo Perna,2,6 Domenico De Berardis,2,7 Nicola Veronese,5,8 Laura Orsolini,2,9 Licinia Ganança,1,10 Brendon Stubbs11,12 1New York State Psychiatric Institute, Columbia University, New York City, NY, USA; 2Polyedra Research Group®, Ascoli, 3Department of Neurosciences, University of Padua, 4Department of Mental Health, National Health Service, Padova, 5IREM Institute for Clinical Research and Education in Medicine, Padova, 6Department of Clinical Neurosciences, Hermanas Hospitalarias – Villa San Benedetto Menni Hospital, FoRiPsi, Albese con Cassano, Como, 7Department of Mental Health, Psychiatric Service of Diagn…
COX-2 inhibition and pain management: a review summary
2005
Cyclooxygenase-2 selective inhibitors have long been regarded as potent anti-inflammatory drugs for the treatment of arthritis, osteoarthritis and dysmenorrhea. The reports of cardiovascular risk and the subsequent withdrawal of rofecoxib, and recently valdecoxib, has called the therapeutic potential of coxibs into question. Currently, according to the latest decisions of the US Food and Drug Administration and European Medicines Agency, the approval of valdecoxib has been refused for 1 year due to an increased rate of cardiovascular risks and serious skin reactions. There are restrictions concerning the use of all other coxibs. The short-time use of coxibs, however, in anti-inflammatory tr…
Formulation predictive dissolution (fPD) testing to advance oral drug product development: an introduction to the US FDA funded ‘21st Century BA/BE’ …
2018
Over the past decade, formulation predictive dissolution (fPD) testing has gained increasing attention. Another mindset is pushed forward where scientists in our field are more confident to explore the in vivo behavior of an oral drug product by performing predictive in vitro dissolution studies. Similarly, there is an increasing interest in the application of modern computational fluid dynamics (CFD) frameworks and high-performance computing platforms to study the local processes underlying absorption within the gastrointestinal (GI) tract. In that way, CFD and computing platforms both can inform future PBPK-based in silico frameworks and determine the GI-motility-driven hydrodynamic impac…
A novel arousal-based individual screening reveals susceptibility and resilience to PTSD-like phenotypes in mice
2021
Translational animal models for studying post-traumatic stress disorder (PTSD) are valuable for elucidating the poorly understood neurobiology of this neuropsychiatric disorder. These models should encompass crucial features, including persistence of PTSD-like phenotypes triggered after exposure to a single traumatic event, trauma susceptibility/resilience and predictive validity. Here we propose a novel arousal-based individual screening (AIS) model that recapitulates all these features. The AIS model was designed by coupling the traumatization (24 h restraint) of C57BL/6 J mice with a novel individual screening. This screening consists of z-normalization of post-trauma changes in startle …
Detoxifying antitumoral drugs via nanoconjugation: the case of gold nanoparticles and cisplatin
2021
Nanoparticles (NPs) have emerged as a potential tool to improve cancer treatment. Among the proposed uses in imaging and therapy, their use as a drug delivery scaffold has been extensively highlighted. However, there are still some controversial points which need a deeper understanding before clinical application can occur. Here the use of gold nanoparticles (AuNPs) to detoxify the antitumoral agent cisplatin, linked to a nanoparticle via a pH-sensitive coordination bond for endosomal release, is presented. The NP conjugate design has important effects on pharmacokinetics, conjugate evolution and biodistribution and results in an absence of observed toxicity. Besides, AuNPs present unique o…
TiO2 in the food industry and cosmetics
2021
Abstract The white pigment titanium dioxide is widely used in foodstuff and cosmetics mainly because it provides whitening effect, it acts as a physical filter in sunscreen products, and due to its photocatalytic properties. As food additive, it is labeled as E171 (Europe) and INS171 (United States), and its use was approved in 1966 by the US Food and Drug Administration and in 1969 by the European Union. According to a request of the European Commission, a scientific reevaluation of the safety of TiO2 when used as food additive was recently elaborated by European Food Safety Authority ANS panel. The TiO2 photocatalytic inactivation power is widely studied in order to nonthermally decontami…
Lipid Delivery Systems for Nucleic-Acid-Based-Drugs: From Production to Clinical Applications
2019
In the last years the rapid development of Nucleic Acid Based Drugs (NABDs) to be used in gene therapy has had a great impact in the medical field, holding enormous promise, becoming “the latest generation medicine” with the first ever siRNA-lipid based formulation approved by the United States Food and Drug Administration (FDA) for human use, and currently on the market under the trade name Onpattro™. The growth of such powerful biologic therapeutics has gone hand in hand with the progress in delivery systems technology, which is absolutely required to improve their safety and effectiveness. Lipid carrier systems, particularly liposomes, have been proven to be the most su…