Sensitivity And Specificity Of In Vitro Diagnostic Device Used For Influenza Rapid Test In Taiwan,
2020
Taiwan Food and Drug Administration
Sensitivity And Specificity Of In Vitro Diagnostic Device Used For Influenza Rapid Test In Taiwan, K.-T. Wang, C.-P. Lin, Y.-Y. Fang, M.-H. Kao, D.Y.-C. Shih, C.-F. Lo, D.-Y. Wang
Journal of Food and Drug Analysis
The pandemic influenza A/H1N1 outbreak resulted in 18,449 deaths in over 214 countries. In Taiwan, the influenza rapid test, an in vitro diagnostic device (Flu-IVD), only requires documented reviews for market approval by the Taiwan Food and Drug Administration. The purpose of this study was to investigate the analytical sensitivity and specificity of Flu- IVDs used in Taiwan. Analytical sensitivity and specificity tests were performed for influenza antigens A/California/7/2009 (H1N1) virus, A/Victoria/210/2009 (H3N2) virus, B/ Brisbane/60/08 virus, and human coronavirus OC43. A total of seven domestic and 31 imported Flu-IVD samples were collected, of which, 20 samples had inadequate labeling, …
A Relative Bioavailability Study Of 500 Mg Calcium P-Aminosalicylate Film Coating Tablet In Healthy Individuals,
2020
Taiwan Food and Drug Administration
A Relative Bioavailability Study Of 500 Mg Calcium P-Aminosalicylate Film Coating Tablet In Healthy Individuals, C. Cheng, M.-L. Chen, C. Tseng, Y.-S. Uang, C.-L. Huang, K.-Y. Hsu
Journal of Food and Drug Analysis
The purpose of this study is to evaluate the only available calcium p-aminosalicylate (Ca PAS) commercial product, which is one of the most commonly prescribed non-surveillance products fromthe Bureau of National Health Insurance (BNHI) database in Taiwan. An openrandomized, balanced, two-way crossover study was designed to evaluate the relative bioavailability (F) of a 500 mg Ca PAS F.C. tablet with a 500 mg Ca PAS suspension in 13 healthy individuals. Blood samples were collected according to a planned time schedule. The plasma concentrations of PAS were measured by a validated liquid chromatography coupled with tandem mass spectrometry (LC/MS/MS) method. Pharmacokinetic …
Autophagy In Drug-Induced Liver Toxicity,
2020
Taiwan Food and Drug Administration
Autophagy In Drug-Induced Liver Toxicity, S. Chen, W.B. Melchior, Jr., Y. Wu, L. Guo
Journal of Food and Drug Analysis
Liver injury resulting from exposure to drugs and chemicals is a major health problem. Autophagy is an important factor in a wide range of diseases, such as cancer, liver disease, muscular disorder, neurodegeneration, pathogen infection, and aging, and emerging evidence indicates that autophagy makes a substantial contribution to the pathogenesis of drug- And chemical-induced liver toxicity. In this review, we summarize current knowledge on autophagy triggered by toxicants/toxins, the protective role of autophagy in liver toxicity, and the underlying molecular mechanisms. We also highlight experimental approaches for studying autophagy. Copyright © 2013, Food and Drug Administration, Taiwan.
Effect Of Water Cooking On Antioxidant Capacity Of Carotenoid-Rich Vegetables In Taiwan,
2020
Taiwan Food and Drug Administration
Effect Of Water Cooking On Antioxidant Capacity Of Carotenoid-Rich Vegetables In Taiwan, F.-J. Kao, Y.-S. Chiu, W.-D. Chiang
Journal of Food and Drug Analysis
Carotenoid-rich green leafy vegetables including cilantro, Thai basil leaves, sweet potato leaves, and choy sum were selected to evaluate the effects of water cooking or boiling on their total carotenoid content (TCC), total phenolic content (TPC), and total antioxidant capacity (TAC). The percentage inhibition of peroxidation (%IP), Trolox equivalent antioxidant capacity (TEAC), and metal-chelating effect were used to evaluate TAC. The results indicated that TCC reached the maximum after boiling cilantro, Thai basil leaves, and sweet potato leaves for 10 minutes, 5 minutes, and 5 minutes, respectively, and choy sum remained almost unchanged after 30 minutes of boiling. Boiling cilantro …
Tetrodotoxin And Paralytic Shellfish Poisons In Gastropod Species From Vietnam Analyzed By Highperformance Liquid Chromatography And Liquid Chromatography-Tandem Mass Spectrometry,
2020
Taiwan Food and Drug Administration
Tetrodotoxin And Paralytic Shellfish Poisons In Gastropod Species From Vietnam Analyzed By Highperformance Liquid Chromatography And Liquid Chromatography-Tandem Mass Spectrometry, H.-C. Jen, Nguyen T. Anh-Tuyet, Y.-J. Wu, T. Hoang, O. Arakawa, W.-F. Lin, D.-F. Hwang
Journal of Food and Drug Analysis
notorious neurotoxins that induce serious food poisoning incidents in the Southeast Asia region. The aim of this study was to investigate whether TTX and PSP toxins are important issues of seafood safety. Paralytic toxicity was observed in mice exposed to 34 specimens from five species of gastropods using a PSP bioassay. Five species of gastropods, Natica vitellus, Natica tumidus, Oliva hirasei, Oliva lignaria, and Oliva annulata, were collected from the coastal seawaters in Nha Trang City, Vietnam, between August 2007 and October 2007. The average lethal potency of gastropod specimens was 90 ± 40 (mean ± standard deviation) mouse units …
Forced Degradation Behavior Of Epidepride And Development Of A Stability-Indicating Method Based On Liquid Chromatography-Mass Spectrometry,
2020
Taiwan Food and Drug Administration
Forced Degradation Behavior Of Epidepride And Development Of A Stability-Indicating Method Based On Liquid Chromatography-Mass Spectrometry, W.-H. Chen, Y.-Y. Lin, Y. Chang, K.-W. Chang, Y.-C. Shia, K.-T. Liu
Journal of Food and Drug Analysis
A reversed-phase high performance liquid chromatography (RP-HPLC) and LC-tandem mass spectrometry (LC-MS/MS) method was applied to study the forced degradation behavior and stability of epidepride. 123I radioisotope-labeled epidepride, ((-)-N-[[(2S)-1-ethylpyrrolidin-2-yl]methyl]-5-iodo-2,3-dimethoxybenzamide) is a radio-tracer with a very high affinity for dopamine D2 receptors in the brain and has been used as an imaging agent for single-photon emission computed tomography (SPECT). HPLC studies were performed using 127I-epidepride (the non-radioactive compound), instead of 123I-epidepride, with an RP-18 column using a mobile phase consisting of methanol, acetonitrile, and ammonium acetate (pH 7.0, 10 mM). The eluent flow rate and the wavelength for HPLC detection were …
Genotoxicity Of Titanium Dioxide Nanoparticles,
2020
Taiwan Food and Drug Administration
Genotoxicity Of Titanium Dioxide Nanoparticles, T. Chen, J. Yan, Y. Li
Journal of Food and Drug Analysis
Titanium dioxide nanoparticles (TiO2-NPs, < 100 nm) are increasingly being used in pharmaceuticals and cosmetics due to the unique properties derived from their small sizes. However, their large surface-area to mass ratio and high redox potential may negatively impact human health and the environment. TiO2-NPs can cause inflammation, pulmonary damage, fibrosis, and lung tumors and they are possibly carcinogenic to humans. Because cancer is a disease involving mutation, there are a large number of studies on the genotoxicity of TiO2-NPs. In this article, we review the results that have been reported in the literature, with a focus on data generated from the standard genotoxicity assays. The data include genotoxicity results from the Ames test, in vitro and in vivo Comet assay, in vitro and in vivo micronucleus assay, sister chromatid exchange assay, mammalian cell hypoxanthine-guanine phosphoribosyl transferase gene assay, the wing somatic mutation and recombination assay, and the mouse phosphatidylinositol glycan, class A gene assay. Inconsistent results have been found in these assays, with both positive and negative responses being reported. The in vitro systems for assessing the genotoxicity of TiO2-NPs have generated a greater number of positive results than the in vivo systems, and tests for DNA and chromosome damage have produced more positive results than the assays measuring gene mutation. Nearly all tests for measuring the mutagenicity of TiO2-NPs were negative. The current data indicate that the genotoxicity of TiO2-NPs is mediated mainly through the generation of oxidative stress in cells.
Raman Spectroscopy In The Analysis Of Food And Pharmaceutical Nanomaterials,
2020
Taiwan Food and Drug Administration
Raman Spectroscopy In The Analysis Of Food And Pharmaceutical Nanomaterials, Y.-S. Li, J.S. Church
Journal of Food and Drug Analysis
Raman scattering is an inelastic phenomenon. Although its cross section is very small, recent advances in electronics, lasers, optics, and nanotechnology have made Raman spectroscopy suitable in many areas of application. The present article reviews the applications of Raman spectroscopy in food and drug analysis and inspection, including those associated with nanomaterials. Brief overviews of basic Raman scattering theory, instrumentation, and statistical data analysis are also given. With the advent of Raman enhancement mechanisms and the progress being made in metal nanomaterials and nanoscale metal surfaces fabrications, surface enhanced Raman scattering spectroscopy has become an extra sensitive method, which is …
Reactive Oxygen Species-Related Activities Of Nano-Iron Metal And Nano-Iron Oxides,
2020
Taiwan Food and Drug Administration
Reactive Oxygen Species-Related Activities Of Nano-Iron Metal And Nano-Iron Oxides, H. Wu, J.-J. Yin, W.G. Wamer, M. Zeng, Y.M. Lo
Journal of Food and Drug Analysis
Nano-iron metal and nano-iron oxides are among the most widely used engineered and naturally occurring nanostructures, and the increasing incidence of biological exposure to these nanostructures has raised concerns about their biotoxicity. Reactive oxygen species (ROS)-induced oxidative stress is one of the most accepted toxic mechanisms and, in the past decades, considerable efforts have been made to investigate the ROS-related activities of iron nanostructures. In this review, we summarize activities of nano-iron metal and nano-iron oxides in ROS-related redox processes, addressing in detail the known homogeneous and heterogeneous redox mechanisms involved in these processes, intrinsic ROS-related properties of iron nanostructures …
Electron Spin Resonance Spectroscopy For The Study Of Nanomaterial-Mediated Generation Of Reactive Oxygen Species,
2020
Taiwan Food and Drug Administration
Electron Spin Resonance Spectroscopy For The Study Of Nanomaterial-Mediated Generation Of Reactive Oxygen Species, W. He, Y. Liu, W.G. Wamer, J.-J. Yin
Journal of Food and Drug Analysis
Many of the biological applications and effects of nanomaterials are attributed to their ability to facilitate the generation of reactive oxygen species (ROS). Electron spin resonance (ESR) spectroscopy is a direct and reliable method to identify and quantify free radicals in both chemical and biological environments. In this review, we discuss the use of ESR spectroscopy to study ROS generation mediated by nanomaterials, which have various applications in biological, chemical, and materials science. In addition to introducing the theory of ESR, we present some modifications of the method such as spin trapping and spin labeling, which ultimately aid in the …
Introduction To The Special Issue: Nanomaterials - Toxicology And Medical Applications,
2020
Taiwan Food and Drug Administration
Introduction To The Special Issue: Nanomaterials - Toxicology And Medical Applications, P.P. Fu
Journal of Food and Drug Analysis
[No abstract available]
Neurotoxicity Of Nanoscale Materials,
2020
Taiwan Food and Drug Administration
Neurotoxicity Of Nanoscale Materials, A. Karmakar, Q. Zhang, Y. Zhang
Journal of Food and Drug Analysis
Nanotechnology has been applied in consumer products and commercial applications, showing a significant impact on almost all industries and all areas of society. Significant evidence indicates that manufactured nanomaterials and combustion-derived nanomaterials elicit toxicity in humans exposed to these nanomaterials. The interaction of the engineered nanomaterials with the nervous system has received much attention in the nanotoxicology field. In this review, the biological effects of metal, metal oxide, and carbon-based nanomaterials on the nervous system are discussed from both in vitro and in vivo studies. The translocation of the nanoparticles through the blood-brain barrier or nose to brain via the …
Mechanistic Characterization Of Titanium Dioxide Nanoparticle-Induced Toxicity Using Electron Spin Resonance,
2020
Taiwan Food and Drug Administration
Mechanistic Characterization Of Titanium Dioxide Nanoparticle-Induced Toxicity Using Electron Spin Resonance, M. Li, J.-J. Yin, W.G. Wamer, Y.M. Lo
Journal of Food and Drug Analysis
Titanium dioxide nanoparticles (TiO2 NPs) are one of the most widely used nanomaterials that have been manufactured worldwide and applied in different commercial realms. The well-recognized ability of TiO2 to promote the formation of reactive oxygen species (ROS) has been extensively studied as one of the important mechanisms underlying TiO2 NPs toxicity. As the "gold standard" method to quantify and identify ROS, electron spin resonance (ESR) spectroscopy has been employed in many studies aimed at evaluating TiO2 NPs safety. This review aims to provide a thorough discussion of current studies using ESR as the primary method to unravel the mechanism …
Molecular Toxicity Mechanism Of Nanosilver,
2020
Taiwan Food and Drug Administration
Molecular Toxicity Mechanism Of Nanosilver, D. Mcshan, P.C. Ray, H. Yu
Journal of Food and Drug Analysis
Silver is an ancient antibiotic that has found many new uses due to its unique properties on the nanoscale. Due to its presence in many consumer products, the toxicity of nanosilver has become a hot topic. This review summarizes recent advances, particularly the molecular mechanism of nanosilver toxicity. The surface of nanosilver can easily be oxidized by O2 and other molecules in the environmental and biological systems leading to the release of Ag+, a known toxic ion. Therefore, nanosilver toxicity is closely related to the release of Ag+. In fact, it is difficult to determine what portion of the toxicity …
Assessment Of The Toxic Potential Of Graphene Family Nanomaterials,
2020
Taiwan Food and Drug Administration
Assessment Of The Toxic Potential Of Graphene Family Nanomaterials, X. Guo, N. Mei
Journal of Food and Drug Analysis
Graphene, a single-atom-thick carbon nanosheet, has attracted great interest as a promising nanomaterial for a variety of bioapplications because of its extraordinary properties. However, the potential for widespread human exposure raises safety concerns about graphene and its derivatives, referred to as graphene-family nanomaterials. This review summarizes recent findings on the toxicological effects and the potential toxicity mechanisms of graphene-family nanomaterials in bacteria, mammalian cells, and animal models. Graphene, graphene oxide, and reduced graphene oxide elicit toxic effects both in vitro and in vivo, whereas surface modifications can significantly reduce their toxic interactions with living systems. Standardization of terminology and the …
Using A Holistic Approach To Assess The Impact Of Engineered Nanomaterials Inducing Toxicity In Aquatic Systems,
2020
Taiwan Food and Drug Administration
Using A Holistic Approach To Assess The Impact Of Engineered Nanomaterials Inducing Toxicity In Aquatic Systems, X. He, W.G. Aker, J. Leszczynski, H.-M. Hwang
Journal of Food and Drug Analysis
In this report, we critically reviewed selected intrinsic physicochemical properties of engineered nanomaterials (ENMs) and their role in the interaction of the ENMs with the immediate surroundings in representative aquatic environments. The behavior of ENMs with respect to dynamic microenvironments at the nanoebioeeco interface level, and the resulting impact on their toxicity, fate, and exposure potential are elaborated. Based on this literature review, we conclude that a holistic approach is urgently needed to fulfill our knowledge gap regarding the safety of discharged ENMs. This comparative approach affords the capability to recognize and understand the potential hazards of ENMs and their …
Theranostic Nanomedicine For Cancer Detection And Treatment,
2020
Taiwan Food and Drug Administration
Theranostic Nanomedicine For Cancer Detection And Treatment, Z. Fan, P.P. Fu, H. Yu, P.C. Ray
Journal of Food and Drug Analysis
Cancer is the second leading cause of death in the USA according to the American Cancer Society. In the past 5 years, "theranostic nanomedicine", for both therapeutics and imaging, has shown to be "the right drug for the right patient at the right moment" to manage deadly cancers. This review article presents an overview of recent developments, mainly from the authors' laboratories, along with potential medical applications for theranostic nanomedicine including basic concepts and critical properties. Finally, we outline the future research direction and possible challenges for theranostic nanomedicine research. Copyright © 2014, Food and Drug Administration, Taiwan. Published by …
Mechanisms Of Nanotoxicity: Generation Of Reactive Oxygen Species,
2020
Taiwan Food and Drug Administration
Mechanisms Of Nanotoxicity: Generation Of Reactive Oxygen Species, P.P. Fu, Q. Xia, H.-M. Hwang, P.C. Ray, H. Yu
Journal of Food and Drug Analysis
Nanotechnology is a rapidly developing field in the 21st century, and the commercial use of nanomaterials for novel applications is increasing exponentially. To date, the scientific basis for the cytotoxicity and genotoxicity of most manufactured nanomaterials are not understood. The mechanisms underlying the toxicity of nanomaterials have recently been studied intensively. An important mechanism of nanotoxicity is the generation of reactive oxygen species (ROS). Overproduction of ROS can induce oxidative stress, resulting in cells failing to maintain normal physiological redox-regulated functions. This in turn leads to DNA damage, unregulated cell signaling, change in cell motility, cytotoxicity, apoptosis, and cancer initiation. …
Cell Microenvironment Stimuli-Responsive Controlled-Release Delivery Systems Based On Mesoporous Silica Nanoparticles,
2020
Taiwan Food and Drug Administration
Cell Microenvironment Stimuli-Responsive Controlled-Release Delivery Systems Based On Mesoporous Silica Nanoparticles, C.-L. Zhu, X.-W. Wang, Z.-Z. Lin, Z.-H. Xie, X.-R. Wang
Journal of Food and Drug Analysis
To develop novel tumor cell microenvironment stimuli-responsive smart controlled-release delivery systems is one of the current common interests of materials science and clinical medicine. Meanwhile, mesoporous silica nanoparticles as a promising drug carrier have become the new area of interest in the field of biomedical application in recent years because of their unique characteristics and abilities to efficiently and specifically entrap cargo molecules. This review describes the more recent developments and achievements of mesoporous silica nanoparticles in drug delivery. In particular, we focus on the stimuli-responsive controlled-release systems that are able to respond to tumor cell environmental changes, such as …
Effects Of Drying On Caffeoylquinic Acid Derivative Content And Antioxidant Capacity Of Sweet Potato Leaves,
2020
Taiwan Food and Drug Administration
Effects Of Drying On Caffeoylquinic Acid Derivative Content And Antioxidant Capacity Of Sweet Potato Leaves, T.L. Jeng, C.C. Lai, T.C. Liao, S.Y. Lin, J.M. Sung
Journal of Food and Drug Analysis
Caffeoylquinic acid (CQA) derivatives are known to possess antioxidative potential and have many beneficial effects on human health. The present study compared the CQA contents and antioxidant activities of aerial parts of sweet potato plants. The effects of drying methods (freeze drying, and drying at 30°C, 70°C, and 100°C) on these two parameters of the first fully expanded leaves were also assessed. The results indicated that the CQA derivatives were detectable in leaves, stem, and flowers of sweet potato plants (varied from 39.34 mg/g dry weight to 154.05 mg/g dry weight), with the leaves (particularly expanding and first fully expanded …
