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FDA Research

03:32 EDT 24th June 2018 | BioPortfolio

Use of prescription drugs among women diagnosed with epithelial ovarian cancer in Denmark.

Epithelial ovarian cancer patients often suffer from chronic diseases requiring drug treatment. We assessed temporal patterns of drug use among ovarian cancer patients MATERIAL AND METHODS: We identified all post-menopausal women with epithelial ovarian cancer in Denmark 2005-2012 and a comparison cohort of age-matched women without cancer. We calculated rates of new drug treatment and total drug ...

The World Health Organization - Community Empowerment Model in Addressing Food Insecurity in Low-Income African-American Women: A Review of the Literature.

Numerous researchers have examined the serious consequences of food insecurity and food deserts affecting the nutritional health of poor or low-income African-American women and their families. Food insecurity is defined as having limited or uncertain capacityfor acquiring sufficient, safe, and nutritious food at all times to meet one's dietary needs, while food deserts refer to economically and s...

Medical Devices; Neurological Devices; Classification of the Percutaneous Nerve Stimulator for Substance Use Disorders. Final order.

The Food and Drug Administration (FDA or we) is classifying the percutaneous nerve stimulator for substance use disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the percutaneous nerve stimulator for substance use disorders' classification. We are taking this action because we ha...

Medical Devices; General and Plastic Surgery Devices; Classification of the Non-Absorbable, Hemostatic Gauze for Temporary Internal Use. Final order.

The Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non-absorbable, hemostatic gauze for temporary internal use's classification. We are taking this action because ...

Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices. Final rule.

The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo class...

Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test Systems. Final order.

The Food and Drug Administration (FDA or we) is classifying Lynch syndrome test systems into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Lynch syndrome test systems' classification. We are taking this action because we have determined that classifying the device into class II (spe...

Tuning the Diels-Alder Reaction for Bioconjugation to Maleimide Drug-Linkers.

The thiol-maleimide linkage is widely used for antibody-drug conjugate (ADC) production; however, conjugation of maleimide-drugs could be improved by simplified procedures and reliable conjugate stability. Here, we report the evaluation of electron-rich and cyclic dienes that can be appended to antibodies and reacted with maleimide-containing drugs through the Diels-Alder (DA) reaction. Drug conju...

Interactions of artefenomel (OZ-439) with milk during digestion: insights into digestion-driven solubilization and polymorphic transformations.

Milk has been used as a vehicle for the delivery of antimalarial drugs during clinical trials to test for a food effect and artefenomel (OZ439) showed enhanced oral bioavailability with milk. However, the nature of the interaction between milk and OZ439 in the gastrointestinal tract remains poorly understood. To understand the role of milk digestion on the solubilization of OZ439 and polymorphism,...

Tuning Spatial Profiles of Selection Pressure to Modulate the Evolution of Drug Resistance.

Spatial heterogeneity plays an important role in the evolution of drug resistance. While recent studies have indicated that spatial gradients of selection pressure can accelerate resistance evolution, much less is known about evolution in more complex spatial profiles. Here we use a stochastic toy model of drug resistance to investigate how different spatial profiles of selection pressure impact t...

The intranasal gels of Box-Behnken experimental design for preparation and optimization of selegiline hydrochloride.

Selegiline hydrochloride (SL) is chosen as an adjunct for the control of clinical signs of Parkinsonian patients. The aim of the present work is to develop and optimize thermosensitive gels using Pluronic (F-127) for enhancing transport of SL into the brain through the nasal route. SL gels were prepared using a cold method and the Box-Behnken experimental design methodology. Drug (SL), gelling age...

Chloroquine and nanoparticle drug delivery: A promising combination.

Clinically approved cancer therapies include small molecules, antibodies, and nanoparticles. There has been major progress in the treatment of several cancer types over recent decades. However, many challenges remain for optimal use of conventional and nanoparticle-based therapies in oncology including poor drug delivery, rapid clearance, and drug resistance. The antimalarial agent chloroquine has...

Administration of a co-crystal of tramadol and celecoxib in a 1:1 molecular ratio produces synergistic antinociceptive effects in a postoperative pain model in rats.

Drug combination for the treatment of pain is common clinical practice. Co-crystal of Tramadol-Celecoxib (CTC) consists of two active pharmaceutical ingredients (APIs), namely the atypical opioid tramadol and the preferential cyclooxygenase-2 inhibitor celecoxib, at a 1:1 molecular ratio. In this study, a non-formulated 'raw' form of CTC administered in suspension (referred to as ctc) was compared...

Synergy between chemical permeation enhancers and drug permeation across the tympanic membrane.

Chemical permeation enhancers (CPEs) can enable antibiotic flux across the tympanic membrane. Here we study whether combinations of CPEs (sodium dodecyl sulfate, limonene, and bupivacaine hydrochloride) are synergistic and whether they could increase the peak drug flux. Synergy is studied by isobolographic analysis and combination indices. CPE concentration-response (i.e. trans-tympanic flux of ci...

Drug adulteration of food supplements: A threat to public health in the European Union?

Food supplements have been playing an increasingly important role in the consumers' awareness nowadays. They are widespread and - according to popular belief - healthier and safer than synthetic drugs. In the European Union (EU) food supplements are classified as foodstuffs and thus not subjected to any specific safety assessments prior to commercialisation. With the growing popularity of food sup...

Prioritization before risk assessment: The viability of uncertain data on food contact materials.

The shortage of data on non-intentionally added substances (NIAS) present in food contact material (FCM) limits the ability to ensure food safety. Recent strategies in analytical method development allow investigating NIAS by using chemical exploration; but this has not been sufficiently investigated in risk assessment context. Here, exploration is applied on two paperboard FCM samples followed by...

Facile synthesis and characterization of tailor-made pectin-gellan gum-bionanofiller composites as intragastric drug delivery shuttles.

Olive oil-entrapped diethanolamine-modified high-methoxyl pectin (DMP)-gellan gum (GG)-bionanofiller composites were developed for controlled intragastric delivery of metformin HCl (MFM). DMP had a degree of amidation of 48.7% and was characterized further by FTIR, XRD and DSC analyses. MFM-loaded composites were subsequently accomplished by green synthesis via ionotropic gelation technique using ...

CDK4/6 inhibitors in breast cancer therapy: Current practice and future opportunities.

Dysregulation of the cyclin dependent kinase pathway in luminal breast cancer creates a new therapeutic opportunity for estrogen receptor positive breast cancer. Initial pan-CDK inhibitors were associated with extensive toxicities but in recent years, the development of potent specific CDK inhibitors with favorable tolerability has driven renewed interests in this class of targeted therapies. Palb...

Toxicology study for magnetic injection of prednisolone into the rat cochlea.

This paper investigates the safety of a novel 'magnetic injection' method of delivering therapy to the cochlea, in a rodent model. In this method of administration, a magnetic field is employed to actively transport drug-eluting iron oxide-core nanoparticles into the cochlea, where they then release their drug payload (we delivered the steroid prednisolone). Our study design and selection of contr...

Optimization of nanostructured lipid carriers for Zidovudine delivery using a microwave-assisted production method.

An adapted methodology for obtaining lipid nanoparticles that only uses the microwave reactor in the synthesis process was developed. The method has the following features: one-pot, one-step, fast, practical, economical, safe, readiness of scaling-up, lack of organic solvents and production of nanoparticles with low polydispersity index (PDI) (below 0.3). This new method was applied for the develo...

Understanding the health and wellbeing challenges of the food banking system: A qualitative study of food bank users, providers and referrers in London.

In the UK, food poverty has been associated with conditions such as obesity, malnutrition, hypertension, iron deficiency, and impaired liver function. Food banks, the primary response to food poverty on the ground, typically rely on community referral and distribution systems that involve health and social care professionals and local authority public health teams. The perspectives of these key st...

Effect of food microstructure on growth dynamics of Listeria monocytogenes in fish-based model systems.

Traditionally, predictive growth models for food pathogens are developed based on experiments in broth media, resulting in models which do not incorporate the influence of food microstructure. The use of model systems with various microstructures is a promising concept to get more insight into the influence of food microstructure on microbial dynamics. By means of minimal variation of compositiona...

Acute Opioid-Induced Myoclonic Reaction after Use of Fentanyl as an Anesthetic Drug for an Emergency Cesarean Section.

Myoclonus is an abnormal involuntary movement that has been previously reported with administration of high doses of opioids for prolonged periods of time. In this case, however, we report an acute myoclonic reaction and review the literature on the possible causative pathophysiology. We report the case of a 24-year-old woman who was admitted for postdated cesarean section. She started to have abn...

Mitoxantrone induces apoptosis in osteosarcoma cells through regulation of the Akt/FOXO3 pathway.

The outcome of chemotherapy for osteosarcoma have improved during the past decade and more patients have access to combination chemotherapy, but there has been no significant clinical progress in the patient survival rate. Recently, forkhead-box O3 (FOXO3) was identified as a pivotal transcription factor responsible for the transcriptional regulation of genes associated with suppression of cancer....

Aptamers: novelty tools for cancer biology.

Although the term 'cancer' was still over two thousand years away of being coined, the first known cases of the disease date back to about 3000BC, in ancient Egypt. Five thousand years later, still lacking a cure, it has become one of the leading causes of death, killing over half a dozen million people yearly. So far, monoclonal antibodies are the most successful immune-therapy tools when it come...

Lower Blood Alcohol Concentration among HIV-Positive versus HIV-Negative Individuals Following Controlled Alcohol Administration.

Although it has been purported that HIV-positive individuals may experience a greater degree of intoxication than HIV-negative individuals following acute alcohol consumption, no research to date has empirically tested this supposition. The present investigation entailed a randomized controlled experiment to identify whether the administration of a weight-specified dose of alcohol would lead to di...

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