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1.
PLoS One ; 19(3): e0294537, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38446831

RESUMEN

Credit card fraud is a significant problem that costs billions of dollars annually. Detecting fraudulent transactions is challenging due to the imbalance in class distribution, where the majority of transactions are legitimate. While pre-processing techniques such as oversampling of minority classes are commonly used to address this issue, they often generate unrealistic or overgeneralized samples. This paper proposes a method called autoencoder with probabilistic xgboost based on SMOTE and CGAN(AE-XGB-SMOTE-CGAN) for detecting credit card frauds.AE-XGB-SMOTE-CGAN is a novel method proposed for credit card fraud detection problems. The credit card fraud dataset comes from a real dataset anonymized by a bank and is highly imbalanced, with normal data far greater than fraud data. Autoencoder (AE) is used to extract relevant features from the dataset, enhancing the ability of feature representation learning, and are then fed into xgboost for classification according to the threshold. Additionally, in this study, we propose a novel approach that hybridizes Generative Adversarial Network (GAN) and Synthetic Minority Over-Sampling Technique (SMOTE) to tackle class imbalance problems. Our two-phase oversampling approach involves knowledge transfer and leverages the synergies of SMOTE and GAN. Specifically, GAN transforms the unrealistic or overgeneralized samples generated by SMOTE into realistic data distributions where there is not enough minority class data available for GAN to process effectively on its own. SMOTE is used to address class imbalance issues and CGAN is used to generate new, realistic data to supplement the original dataset. The AE-XGB-SMOTE-CGAN algorithm is also compared to other commonly used machine learning algorithms, such as KNN and Light GBM, and shows an overall improvement of 2% in terms of the ACC index compared to these algorithms. The AE-XGB-SMOTE-CGAN algorithm also outperforms KNN in terms of the MCC index by 30% when the threshold is set to 0.35. This indicates that the AE-XGB-SMOTE-CGAN algorithm has higher accuracy, true positive rate, true negative rate, and Matthew's correlation coefficient, making it a promising method for detecting credit card fraud.


Asunto(s)
Algoritmos , Suplementos Dietéticos , Fraude/prevención & control , Conocimiento , Aprendizaje Automático
2.
Sensors (Basel) ; 23(3)2023 Feb 03.
Artículo en Inglés | MEDLINE | ID: mdl-36772764

RESUMEN

Adulterations of olive oil are performed by adding seed oils to this high-quality product, which are cheaper than olive oils. Food safety controls have been established by the European Union to avoid these episodes. Most of these methodologies require expensive equipment, time-consuming procedures, and expert personnel to execute. Near-infrared spectroscopy (NIRS) technology has many applications in the food processing industry. It analyzes food safety and quality parameters along the food chain. Using principal component analysis (PCA), the differences and similarities between olive oil and seed oils (sesame, sunflower, and flax oil) have been evaluated. To quantify the percentage of adulterated seed oil in olive oils, partial least squares (PLS) have been employed. A total of 96 samples of olive oil adulterated with seed oils were prepared. These samples were used to build a spectra library covering various mixtures containing seed oils and olive oil contents. Eighteen chemometric models were developed by combining the first and second derivatives with Standard Normal Variable (SNV) for scatter correction to classify and quantify seed oil adulteration and percentage. The results obtained for all seed oils show excellent coefficients of determination for calibration higher than 0.80. Because the instrumental aspects are not generally sufficiently addressed in the articles, we include a specific section on some key aspects of developing a high-performance and cost-effective NIR spectroscopy solution for fraud detection in olive oil. First, spectroscopy architectures are introduced, especially the Texas Instruments Digital Light Processing (DLP) technology for spectroscopy that has been used in this work. These results demonstrate that the portable prototype can be used as an effective tool to detect food fraud in liquid samples.


Asunto(s)
Aceites de Plantas , Espectroscopía Infrarroja Corta , Aceite de Oliva/análisis , Aceites de Plantas/análisis , Espectroscopía Infrarroja Corta/métodos , Contaminación de Alimentos/análisis , Fraude/prevención & control , Aceite de Girasol
3.
J Phys Chem Lett ; 13(4): 1090-1098, 2022 Feb 03.
Artículo en Inglés | MEDLINE | ID: mdl-35080405

RESUMEN

Multifunctional probes with high utilization rates have great value in practical applications in various fields such as cancer diagnosis and therapy. Here we have synthesized two organic molecules based on merocyanine. They can self-assemble in water to form ∼1.5 nm nanoparticles. Both of them have good application potential in fluorescent anticounterfeit printing ink and pH detection. More importantly, they have excellent mitochondrial targeting ability, intracellular red light and near-infrared dual-channel imaging ability, strong antiphotobleaching ability, and in vivo and in vitro near-infrared imaging capabilities, showing superior chemotherapy capabilities and biocompatibility in the 4T1 tumor-bearing mouse model.


Asunto(s)
Antineoplásicos/uso terapéutico , Benzopiranos/uso terapéutico , Indicadores y Reactivos/uso terapéutico , Indoles/uso terapéutico , Nanopartículas/uso terapéutico , Neoplasias/tratamiento farmacológico , Animales , Antineoplásicos/química , Apoptosis/efectos de los fármacos , Benzopiranos/química , Línea Celular Tumoral , Fraude/prevención & control , Humanos , Concentración de Iones de Hidrógeno , Indicadores y Reactivos/química , Indoles/química , Tinta , Potencial de la Membrana Mitocondrial/efectos de los fármacos , Ratones , Mitocondrias/efectos de los fármacos , Nanopartículas/química , Neoplasias/metabolismo , Especies Reactivas de Oxígeno/metabolismo
4.
Food Chem ; 352: 129422, 2021 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-33714164

RESUMEN

The fatty acid, squalene, and phytosterols, coupled to chemometrics were utilized to detect the adulteration of camellia oil (CAO) with palm superolein (PAO), refined olive oil (ROO), high oleic- sunflower oil (HO-SUO), sunflower oil (SUO), corn oil (COO), rice bran oil (RBO), rice oil (RIO), peanut oil (PEO), sesame oil (SEO), soybean oil (SOO), and rapeseed oil (RAO). CAO was characterized with higher triterpene alcohols, thus differentiated from other vegetable oils in principle component analysis (PCA). Using partial least squares-discriminant analysis (PLS-DA), CAO adulterated with PAO, ROO, HO-SUO, SUO, COO, RBO, RIO, PEO, SEO, SOO, RAO (5%-100%, w/w), could be classified, especially higher than 92.31% of the total discrimination accuracy, at an adulterated ratio above 30%. With less than 22 potential key markers selected by the variable importance in projection (VIP), the optimized PLS models were confirmed to be accurate for the adulterated level prediction in CAO.


Asunto(s)
Camellia/química , Ácidos Grasos/análisis , Fraude/prevención & control , Cromatografía de Gases y Espectrometría de Masas , Informática , Fitosteroles/análisis , Aceites de Plantas/química , Análisis Discriminante , Contaminación de Alimentos/análisis , Análisis de los Mínimos Cuadrados , Análisis de Componente Principal
5.
Food Chem ; 347: 128959, 2021 Jun 15.
Artículo en Inglés | MEDLINE | ID: mdl-33465688

RESUMEN

Laoshan green teas plucked in summer and autumn were measured by high performance liquid chromatography-diode array detector (HPLC-DAD). After baseline correction, the fingerprints data were resolved by multivariate curve resolution-alternating least squares (MCR-ALS) and a total of 57 components were acquired. Relative concentrations of these components were afterwards applied to distinguish plucking seasons using principal component analysis (PCA), support vector machines (SVM) and partial least squares-discriminant analysis (PLS-DA). For both SVM and PLS-DA models, the total recognition rates of training set, cross-validation and testing set were 100%, 91.3% and 100%, respectively. Besides, three variable selection methods were employed to determine characteristic components for the authentication of summer and autumn teas. Results showed that PLS-DA model based on three characteristic components selected by VIP possesses identical predictive ability as the original model. This study demonstrated that our proposed strategy is competent for the authentication of plucking seasons of Laoshan green tea.


Asunto(s)
Cromatografía Líquida de Alta Presión , Análisis de los Alimentos/métodos , Informática , Té/química , Análisis Discriminante , Fraude/prevención & control , Análisis de los Mínimos Cuadrados , Análisis de Componente Principal , Estaciones del Año
6.
Food Chem ; 345: 128815, 2021 May 30.
Artículo en Inglés | MEDLINE | ID: mdl-33333358

RESUMEN

It was aimed to compare the performances of two spectroscopic methods, fluorescence and mid-infrared spectroscopy, in terms of their adulteration detection and estimation of several chemical properties for various cold pressed seed oils. Spectroscopic profiles, fatty acid, free fatty acid and total phenol contents of pumpkin seed, grape seed, black cumin oil, and sesame seed oils were determined and these oils were mixed with sunflower oil at 1-50% (v/v). Both spectroscopic techniques provided comparable results for determination of adulteration of each oil type and the most successful prediction was obtained for pumpkin seed oil at levels >%1. Combined data set of oils resulted in successful quantification of their free fatty acid value, total phenol and major fatty acids contents with both spectroscopic methods regardless of oil type. Both techniques could be used as reliable, fast and environmentally friendly alternatives in the analyses of different types of seed oils.


Asunto(s)
Análisis de los Alimentos/métodos , Aceites de Plantas/química , Espectrometría de Fluorescencia , Espectrofotometría Infrarroja , Calidad de los Alimentos , Fraude/prevención & control
7.
PLoS One ; 15(2): e0229181, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32053689

RESUMEN

Fritillariae cirrhosae bulbus is a famous type of traditional Chinese medicine used for cough relief and eliminating phlegm. The medicine originates from dried bulbs of five species and one variety of Fritillaria. Recently, immature bulbs from other congeneric species, such as F. ussuriensis, have been sold as adulterants of Fritillariae cirrhosae bulbus in medicine markets owing to the high price and limited availability of the genuine medicine. However, it is difficult to accurately identify the bulbs from different original species of Fritillariae cirrhosae bulbus and its adulterants based on traditional methods, although such medicines have different prices and treatment efficacies. The present study adopted DNA barcoding to identify these different species and compared the discriminatory power of super, universal, and specific barcodes in Fritillaria. The results revealed that the super-barcode had strong discriminatory power (87.5%). Among universal barcodes, matK provided the best species resolution (87.5%), followed by ITS (62.5%), rbcL (62.5%), and trnH-psbA (25%). The combination of these four universal barcodes provided the highest discriminatory power (87.5%), which was equivalent to that of the super-barcode. Two plastid genes, ycf1 and psbM-psbD, had much better discriminatory power (both 87.5%) than did other plastid barcodes, and were suggested as potential specific barcodes for identifying Fritillaria species. Phylogenetic analyses indicated that F. cirrhosa was not a "good" species that was composed of multiple lineages, which might have affected the evaluation of the discriminatory ability. This study revealed that the complete plastid genome, as super barcode, was an efficient and reliable tool for identifying the original species of Fritillariae cirrhosae bulbus and its adulterants.


Asunto(s)
Código de Barras del ADN Taxonómico , Fraude/prevención & control , Fritillaria/clasificación , Fritillaria/genética , Variación Genética , Genoma de Plastidios/genética , Filogenia
8.
Sci Rep ; 10(1): 2974, 2020 02 19.
Artículo en Inglés | MEDLINE | ID: mdl-32076084

RESUMEN

The Chinese cordyceps, a complex of the fungus Ophiocordyceps sinensis and its species-specific host insects, is also called "DongChongXiaCao" in Chinese. Habitat degradation in recent decades and excessive harvesting by humans has intensified its scarcity and increased the prices of natural populations. Some counterfeits are traded as natural Chinese cordyceps for profit, causing confusion in the marketplace. To promote the safe use of Chinese cordyceps and related products, a duplex PCR method for specifically identifying raw Chinese cordyceps and its primary products was successfully established. Chinese cordyceps could be precisely identified by detecting an internal transcribed spacer amplicon from O. sinensis and a cytochrome oxidase c subunit 1 amplicon from the host species, at a limit of detection as low as 32 pg. Eleven commercial samples were purchased and successfully tested to further verify that the developed duplex PCR method could be reliably used to identify Chinese cordyceps. It provides a new simple way to discern true commercial Chinese cordyceps from counterfeits in the marketplace. This is an important step toward achieving an authentication method for this Chinese medicine. The methodology and the developmental strategy can be used to authenticate other traditional Chinese medicinal materials.


Asunto(s)
Cordyceps/genética , Medicamentos Falsificados/análisis , Medicamentos Herbarios Chinos/análisis , Fraude/prevención & control , Reacción en Cadena de la Polimerasa , Animales , Cordyceps/química , Medicamentos Falsificados/química , Medicamentos Falsificados/economía , ADN de Hongos/aislamiento & purificación , Medicamentos Herbarios Chinos/economía , Medicamentos Herbarios Chinos/normas , Complejo IV de Transporte de Electrones/genética , Fraude/economía , Genes Fúngicos/genética , Genes de Insecto/genética , Proteínas de Insectos/genética , Insectos/genética , Insectos/microbiología
9.
Anal Chim Acta ; 1088: 89-98, 2019 Dec 11.
Artículo en Inglés | MEDLINE | ID: mdl-31623720

RESUMEN

The principle of chromatographic fingerprint is that certain diagnostic metabolites should be always distributed in a given plant and currently, it has been widely accepted as a promising means for medicinal plant authentication. Moreover, the chemical profile is the only evidence to clarify the ingredients of those consumable plant products, e.g. traditional Chinese medicine (TCM) prescriptions. Herein, efforts were made to describe the diagnostic metabolome of medicinal plant or TCM prescription using a binary code sequence. Forty-five well-known medicinal plants along with six relevant prescriptions were employed for concept illustration and proof. Each plant was subjected to chemical characterization, and diagnostic metabolites of all plants were gathered into a chemical pool containing 595 compounds. A robust method enabling the detection of all 595 constituents was then developed using LC coupled to scheduled multiple reaction monitoring. Analyst™ software was responsible for automatically judging the presence (defined as "1") or absence (defined as "0") of each analyte with a defined signal-to-noise threshold (S/N > 100). After converting each medicinal plant to a binary sequence consisting of 595 codes, an in-house database was built by involving all sequences. The potentials of sequence library retrieval towards plant authentication, preliminary chemical characterization, and deformulation of TCM prescriptions were demonstrated after that the diagnostic metabolome of each test sample was translated to a binary code sequence. Above all, binary code is a flexible tool for diagnostic metabolite sequencing of medicinal plants, and it should be an alternative tool of DNA barcoding towards plant authentication.


Asunto(s)
Metabolómica/métodos , Plantas Medicinales/química , Plantas Medicinales/metabolismo , Métodos Analíticos de la Preparación de la Muestra , Composición de Medicamentos , Prescripciones de Medicamentos , Fraude/prevención & control , Límite de Detección , Medicina Tradicional China
10.
J Pharm Biomed Anal ; 164: 713-724, 2019 Feb 05.
Artículo en Inglés | MEDLINE | ID: mdl-30472590

RESUMEN

Popularity of natural-based preparations supporting the sexual potency significantly increased in recent years, which also led to the increase of illegal use of phosphodiesterase type 5 inhibitor (PDE-5) in sexual performance enhancement products. In this study, a rapid U-HPLC‒HRMS/MS method has been developed to simultaneously determine 59 PDE-5 inhibitors and their analogues. Within the development of sensitive method for analysis of 59 PDE-5 inhibitors and their analogues, both sample preparation procedure, as well as separation / detection conditions have been optimized. Extraction efficiency of particular extraction solvents, influence of different mobile phase additives on target analytes separation, as well as impact of various settings of mass analyzer on sensitivity of detection were examined. Data were collected in the 'full MS/data dependent MS/MS' acquisition mode (full MS-dd-MS/MS). Before the U-HPLC‒HRMS/MS method was used for analysis of real samples, proper validation had been conducted. The precision of the method expressed as the relative standard deviation (RSD) was ≤4.2% and ≤5.2% at spiking concentrations 5 µg/g and 0.25 µg/g, respectively. The limits of quantification were in the range 0.25 - 0.05 µg/g and the recovery ranged between 71 and 90%. The optimized method was successfully applied for analysis of 64 real samples, and 10 of them were proved to contain both registered or unregistered synthetic PDE-5 inhibitors. Additionally, the acquired U-HPLC‒HRMS/MS fingerprints were demonstrated to serve as an efficient tool for revealing of other type of possible fraud in products labeling. Retrospective mining of markers of herbs declared on dietary supplements packaging allowed to assess the trueness / untruth in the declaration of medical herbs composition.


Asunto(s)
Medicamentos Falsificados/análisis , Suplementos Dietéticos/normas , Fraude/prevención & control , Inhibidores de Fosfodiesterasa 5/análisis , Fitoquímicos/normas , Cromatografía Líquida de Alta Presión/métodos , República Checa , Suplementos Dietéticos/análisis , Contaminación de Medicamentos/prevención & control , Límite de Detección , Fitoquímicos/análisis , Espectrometría de Masas en Tándem/métodos
11.
PLoS One ; 13(11): e0207763, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30475878

RESUMEN

Using the Indian medicinal plant Tulsi (Holy Basil) as a case study, we have tested to what extent the discrepancy between vernacular and scientific nomenclature can be resolved, whether the presumed chemical diversity underlying the medicinal use of Tulsi has a genetic component, and whether it is possible to detect this genetic component using genetic barcoding markers. Based on four plastidic markers, we can define several haplotypes within Ocimum that are consistent across these markers. Haplotype II is congruent with O. tenuiflorum, while haplotype I extends over several members of the genus and cannot be resolved into genetically separate subclades. The vernacular subdivision of Tulsi into three types (Rama, Krishna, Vana) can only be partially linked with genetic differences-whereby Rama and Krishna Tulsi can be assigned to O. tenuiflorum, while Vana Tulsi belongs to haplotype I. This genetic difference is mirrored by differences in the profiles of secondary compounds. While developmental state and light quality modulate the amplitude to which the chemical profile is expressed, the profile itself seems to be linked with genetic differences. We finally develop an authentication assay that makes use of a characteristic single nucleotide polymorphism in one of the barcoding markers, establishing a differential restriction pattern that can be used to discriminate Vana Tulsi.


Asunto(s)
Fraude/prevención & control , Internacionalidad , Ocimum sanctum/clasificación , Código de Barras del ADN Taxonómico , Ocimum sanctum/genética , Plastidios/genética
12.
Food Chem ; 250: 89-97, 2018 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-29412933

RESUMEN

An untargeted metabolomics approach based on HRMS has been applied to Colombian green coffee to develop a discrimination model to highlight the most differential compounds. For this purpose, 41 green coffee samples of different genotypes collected from 5 regions were analysed. Samples were extracted with aqueous and organic solvents to cover a wide range of compounds. Sample extracts were randomly injected and data were pre-processed with XCMS software. PCA was used to verify quality control samples behaviour, and PLS-DA and DD-SIMCA were employed to create models for discrimination using VIP variable selection method. Thirteen different compounds correctly separate green coffee samples according to their origin, several related to the quality and health benefits of coffee. Model validation was achieved using both cross-validation and an additional set with coffee samples from different harvest year. The results reveal that UHPLC-(Q)ToF MS-based metabolomics is a suitable tool to develop food origin discrimination strategies.


Asunto(s)
Café/metabolismo , Fraude/prevención & control , Espectrometría de Masas , Metabolómica/métodos , Colombia , Humanos
14.
Artículo en Alemán | MEDLINE | ID: mdl-28929207

RESUMEN

It is the declared objective of the Falsified Medicines Directive 2011/62/EU to further improve the protection of patients from falsified pharmaceuticals. Therefore, it stipulates measures based on which falsified medicines in the supply chain can be more easily identified. This is the European legislature's reaction to an increase in falsified medicines. The EU Falsified Medicines Directive aims to create a uniform, standardized solution for protection from falsified drugs. From 9 February 2019 onward (according to the EU Regulation No. 2016/161), manufacturers may only release prescription drugs bearing two safety features into circulation and pharmacies may only dispense these drugs to patients following a successful authentication.The EU legislature demands that each EU member state establish a non-profit national medicines verification organisation (NMVO) that sets up and operates a national medicines verification system (NMVS) for the authentication of pharmaceuticals. In Germany, this is securPharm e. V., an alliance of the pharmaceutical industry, wholesalers and pharmacies. securPharm e. V. was established in 2011. Since 2013, pharmaceutical companies, wholesalers and pharmacies have been able to use the securPharm system for testing purposes. This article provides an overview of the current project progress of securPharm e. V. as of June 2017.


Asunto(s)
Medicamentos Falsificados , Industria Farmacéutica/legislación & jurisprudencia , Unión Europea , Fraude/legislación & jurisprudencia , Fraude/prevención & control , Política de Salud/legislación & jurisprudencia , Medicamentos bajo Prescripción , Tráfico de Drogas/legislación & jurisprudencia , Tráfico de Drogas/prevención & control , Alemania , Humanos , Programas Nacionales de Salud/legislación & jurisprudencia
15.
Talanta ; 164: 490-502, 2017 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-28107963

RESUMEN

Erectile dysfunction (ED) is a sexual disorder characterized by the inability to achieve or maintain a sufficiently rigid erection. Despite the availability of non-invasive oral treatment options, many patients turn to herbal alternatives. Furthermore, herbal supplements are increasingly gaining popularity in industrialized countries and, as a consequence, quality control is a highly important issue. Unfortunately, this is not a simple task since plants are often crushed and mixed with other plants, which complicates their identification by usage of classical approaches such as microscopy. The aim of this study was to explore the potential use of chromatographic fingerprinting to identify plants present in herbal preparations intended for the treatment of ED. To achieve this goal, a HPLC-PDA and a HPLC-MS method were developed, using a full factorial experimental design in order to acquire characteristic fingerprints of three plants which are potentially beneficial for treating ED: Epimedium spp., Pausinystalia yohimbe and Tribulus terrestris. The full factorial design demonstrated that for all three plant references a C8 column (250mm×4.6mm; 5µm particle size) is best suited; methanol and an ammonium formate buffer (pH 3) were found to be the best constituents for the mobile phase. The suitability of this strategy was demonstrated by analysing several self-made triturations in three different botanical matrices, which mimic the influential effects that could be expected when analysing herbal supplements. To conclude, this study demonstrates that chromatographic fingerprinting could provide a useful means to identify plants in a complex herbal mixture.


Asunto(s)
Cromatografía Líquida de Alta Presión/métodos , Suplementos Dietéticos/análisis , Fraude/prevención & control , Espectrometría de Masas
16.
Health Law Can ; 36(4): 174-90, 2016 May.
Artículo en Inglés | MEDLINE | ID: mdl-27476246

RESUMEN

This three-part paper presents practical holistic models of determining impairment and occupational disability with respect to common "own occupation" and "any occupation" definitions. The models consider physical, emotional and cognitive impairments in unison, and draw upon case law support for empirically based functional assessment of secondary cognitive symptoms arising from psychological conditions, including chronic pain disorders. Case law is presented, primarily in the context of Ontario motor vehicle accident legislation, to demonstrate how triers of fact have addressed occupational disability in the context of chronic pain; and interpreted the "own occupation" and "any occupation" definitions. In interpreting the definitions of "own occupation" and "any occupation", courts have considered various concepts, such as: work as an integrated whole, competitive productivity, demonstrated job performance vs. employment, work adaptation relative to impairment stability, suitable work, retraining considerations, self-employment, and remuneration/socio-economic status. The first segment of the paper reviews the above concepts largely in the context of pre-104 Income Replacement Benefit (IRB) entitlement, while the second segment focuses on post-104 IRB entitlement. In the final segment, the paper presents a critical evaluation of computerized transferable skills analysis (TSAs) in the occupational disability context. By contrast, support is offered for the notion that (neuro) psychovocational assessments and situational work assessments should play a key role in "own occupation" disability determination, even where specific vocational rehabilitation/retraining recommendations are not requested by the referral source (e.g., insurer disability examination).


Asunto(s)
Práctica Clínica Basada en la Evidencia , Modelos Teóricos , Salud Laboral/legislación & jurisprudencia , Evaluación de Capacidad de Trabajo , Trastornos del Conocimiento/diagnóstico , Fraude/prevención & control , Seguro por Discapacidad/economía , Ontario
18.
J Med Toxicol ; 9(4): 313-7, 2013 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-24197664

RESUMEN

Chelation products can be helpful in the treatment of metal poisoning. However, many unapproved products with unproven effectiveness and safety are marketed to consumers, frequently via the internet. This paper describes the primary responsibility of the Health Fraud and Consumer Outreach Branch of the United States Food and Drug Administration to identify and address health fraud products. Efforts to prevent direct and indirect hazards to the population's health through regulatory actions are described.


Asunto(s)
Quelantes/uso terapéutico , Terapia por Quelación , Control de Medicamentos y Narcóticos/legislación & jurisprudencia , Regulación Gubernamental , Medicamentos sin Prescripción/uso terapéutico , United States Food and Drug Administration/legislación & jurisprudencia , Quelantes/efectos adversos , Quelantes/normas , Terapia por Quelación/efectos adversos , Terapia por Quelación/normas , Seguridad de Productos para el Consumidor , Fraude/prevención & control , Humanos , Internet , Medicamentos sin Prescripción/efectos adversos , Medicamentos sin Prescripción/normas , Control de Calidad , Medición de Riesgo , Factores de Riesgo , Estados Unidos
20.
Eur J Pharm Sci ; 48(3): 464-73, 2013 Feb 14.
Artículo en Inglés | MEDLINE | ID: mdl-23262056

RESUMEN

In the frame of increasingly stringent quality assessment required by the regulators, the pharmaceutical industry has to face increasingly sophisticated counterfeiting practices. Counterfeits based on deliberate copying of processes or on the infringement of current patents for generic medicines are not straightforward to detect, unless the molecular probe is the active molecule itself. In this context, impurity profiling is limited. A tool based on the determination of intramolecular isotopic profiles has been developed to provide manufacturers of APIs (Active Pharmaceutical Ingredients) with a new solution to meet this double requirement. Stable isotope analyses by NMR gives direct access to site-specific isotope content at natural abundance. In this report, it is shown how both ²H and ¹³C NMR spectrometry can provide complementary and valuable information that could be applied to link APIs to their manufacturing source. Isotopic ¹³C NMR offers additional benefits over ²H NMR in using robust adiabatic polarization transfer methods, leading to a tremendous reduction in experimental time. Two approaches are illustrated. Firstly, the use of ²H and single pulse ¹³C NMR spectra obtained on 20 commercial ibuprofen samples from different origins show that this combined strategy leads to (i) a unique intramolecular isotope identification and (ii) a preliminary classification of the samples according to the synthetic pathways of the main industrial processes. An approach employing polarization transfer methods applied to 11 commercial naproxen samples, for which ²H and single pulse ¹³C NMR spectra are not exploitable and/or are not accessible in reasonable time. The relative and partial intramolecular ¹³C distribution obtained on naproxen by applying this methodology is sufficiently informative to allow the same conclusions as for ibuprofen. The additional benefits that these approaches should bring to API manufacturers are discussed.


Asunto(s)
Antiinflamatorios no Esteroideos/química , Medicamentos Falsificados/química , Fraude/prevención & control , Ibuprofeno/química , Naproxeno/química , Tecnología Farmacéutica , Antiinflamatorios no Esteroideos/economía , Isótopos de Carbono , Química Farmacéutica , Deuterio , Ibuprofeno/economía , Espectroscopía de Resonancia Magnética , Naproxeno/economía , Análisis de Componente Principal , Control de Calidad
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