International Nomenclature Research Articles

An Analysis of Moldova's Agri-food Products Competitiveness on the EU Market

Abstract The paper presents the competitive advantages and disadvantages of Moldova's agri-food products and its potential on the EU market. In this context, the changes in the agri-food trade structure and pattern trade flows are analyzed. In the given research secondary data provided by the National Bureau of Statistics is used. The study analyzestime series from the period 2001-2014. The analysis includes data of the 24 groups of commodities belonging to agricultural and food products according to the international nomenclature for the classification of products Harmonized Sections 2012 in two digits (HS 01-24). For assessing the competitiveness of the Moldova's agri-food products on the EU market the RTA index is calculated. The obtained results reveal which commodities chapters are competitive, which do not have revealed trade advantages and to those which have some potential and its competitiveness could be improved.

Biosimilars: A consideration of the regulations in the United States and European union

Biosimilars are defined as biological products that are highly similar to a reference product, notwithstanding minor differences in clinically inactive components. Biosimilars show no clinically meaningful differences in safety, purity, and potency of the product in comparison to the reference product. With the ever looming patent expiry of some major high cost biologics, biosimilar production is becoming ever more lucrative to companies. Europe (EU) set the precedent, followed by the United States (US) in early 2012, for the approval process for biosimilars. Therefore, the purpose of this paper is to explore the nature of the regulatory processes in the US and EU and to determine the requirements of each in the approval process of a biosimilar. The current Food and Drug Administration (FDA) and European Medicines Agency's (EMA) guidance documents for biosimilars were reviewed revealing a need for further clarifications, as well as specifically addressing Celltrion's and Sandoz's application for approval for the biosimilars infliximab and filgrastim, respectively. Currently, the FDA and EMA focus on comparability in terms of the clinical, pharmacokinetic (PK)/pharmacodynamic (PD), preclinical, biological activity, and physiochemical characterization results, as well as requiring a robust and consistent manufacturing process. Both the EU and US have prepared guidance documents for biosimilars that will result in biotherapeutics that are as safe and efficacious as the innovator product but the necessity exists to globally harmonize international nonproprietary naming nomenclature and clarify how the concept of pharmacovigilance, extrapolation, and interchangeability will be handled and regulated in the future.

Regulations of Cosmetics across the Globe

Background: Cosmetics are products meant for cleaning, perfuming, beautifying, promoting attractiveness or altering the appearance on application to human body, without involving any physiological activity. In general, the term cosmetic includes a vast range of products mainly used for external care of the human body. To safeguard consumer’s health, each country has its guidance or regulations for cosmetic products. These regulations are legal tools for simplifying and reducing administrative work and ambiguities. Methods: We undertook a structured search of regulations available for cosmetic products in major countries. All countries have been selected basis their well developed and highly recommended regulations and guidance documents. All regulations have been studied and presented here in a comparative manner for their regulatory framework for cosmetics in Canada, United States, European Union and India. All information was collected from mentioned countries regulatory databases maintained and updated by authority of these countries and appropriate review literatures available online. Results: Regulations and guidelines have been studied thoroughly and appropriate information was included in the review through regulatory Authority website available on the internet. Majority of regulatory information for Canada, United States, European Union and India were available at website maintained by their respective authorities. In addition few review articles have been also consulted for introductory part of the manuscript. As per respective country regulations, Import, manufacture and sale procedures of cosmetics must be compliant with legislative regulatory system of respective country. Health Canada regulations on cosmetic products are mentioned in Food and Drugs Act and the Cosmetics Regulations. Cosmetics Notification, essential minimum labeling for consumers are few basic requirements that must be followed by manufacturers for Canadian market. Except for colour additives, United States, Food and Drug Administration (FDA) do not require cosmetic products and ingredients premarket approval. However, manufacturers are always advised to carry out necessary tests and establish safety of their product and all ingredients used in the preparation. New European Community Cosmetics Regulation 1223/2009 has replaced earlier Cosmetics Directive 76/768/EEC and other national provisions that were applicable to cosmetics. The Objective of new Regulation is to have a harmonized rule for all EU member countries. In India, cosmetics are regulated under the scope of Drugs and Cosmetics (D&C) Act 1940 and Rules 1945. Conclusion: The finding of this review is to conclude the comparative regulatory framework for cosmetic products with respect to applicable acts, regulations, ingredients, heavy metals, labeling, notification procedures etc. for different countries. Despite of many differences among these regulations, the availability of quality products in market is the prime objective of each country’s laws and regulations. Keywords: Code of federal regulations, cosmetic notification form, cosmetics, drugs and cosmetics act & rules, international nomenclature for cosmetic ingredients, principal display panel, product information file, responsible person.

Globular layer silicates of the glauconite–illite composition in Upper Proterozoic and Lower Cambrian rocks

The paper presents the generalized results of structural and crystal-chemical study of globular dioctahedral 2 : 1 layer silicates of the glauconite–illite composition (45 samples) taken from the Lower Cambrian sequences of North Siberia (Olenek Uplift); Riphean, Vendian, and Lower Cambrian sequences of East Siberia; Upper Riphean sequences of the South Urals and Srednii Peninsula; and Vendian–Cambrian boundary rocks of the Podolian Dniester region (Ukraine). Monomineral fractions of grains were studied using modern chemical and physical methods: X-ray analysis, oblique-texture electron diffraction (OTED), scanning electron microscopy (SEM), classical chemical and microprobe analyses, IR and Mossbauer spectroscopy, and others. Simulation of the experimental diffraction patterns of glycolated specimens (Sakharov et al., 1999) allowed us to determine the degree of expandability (4–13%), type of expandable layers (16.85 A, smectite and 13.2 A, vermiculite), their proportions in twoand three-component mixed-layers, unit cell parameters b (9.02–9.11 A) and csinβ (9.94–10 A) of mica layers, as well as the degree of short-range order in the alternation of layers of different types (R = 0, 2, 3). The classification of low-charge (layer charge ≈ 0.6–0.85 per f.u.) dioctahedral 2: 1 layer silicates is given with account taken of the recommendations of the International Nomenclature Committee on Micas and Clay Minerals (IMA NC, AIPEA NC) (Reider et al., 1998; Guggenheim et al., 2006). Based on the crystal-chemical data on 79 samples obtained in (Ivanovskaya et al., 2012) and in the present paper, it is shown that the globular micaceous varieties are represented by a continuous isomorphic series ranging from illites through Fe-illite and Al-glauconite to glauconites (VIAl/(VIFe3+ + VIAl) = 0.81–0.91, 0.60–0.78, 0.51–0.59, and 0.11–0.50, respectively). Following (Kossovskaya and Drits, 1971; Drits et al., 2013), we distinguish Fe-illites (VIAl/(VIFe3+ + VIAl) = 0.6–0.8) and retain the term Alglauconite for mineral varieties with the Al index KAl = VIAl/(VIFe3+ + VIAl) between 0.51 and 0.59. The structural characteristics (unit cell parameters b, csinβ, and others) and IR spectroscopic data on illite, Fe-illite, Al-glauconite, and glauconite are compared. Special attention is given to samples with elevated Mg contents found in these groups of mineral varieties. Since compositional variations of the studied glauconite–illite minerals fall beyond the fields accepted for these minerals by IMA NC and AIPEA NC, the existing classifications for low-charge dioctahedral micaceous micas may need to be revised.

Contribution to interplay between a delamination test and a sensory analysis of mid-range lipsticks.

Lipstick is currently one of the most sold products of cosmetics industry, and the competition between the various manufacturers is significant. Customers mainly seek products with high spreadability, especially long-lasting or long wear on the lips. Evaluation tests of cosmetics are usually performed by sensory analysis. This can then represent a considerable cost. The object of this study was to develop a fast and simple test of delamination (objective method with calibrated instruments) and to interplay the obtained results with those of a discriminative sensory analysis (subjective method) in order to show the relevance of the instrumental test. Three mid-range lipsticks were randomly chosen and were tested. They were made of compositions as described by the International Nomenclature of Cosmetic Ingredients (INCI). Instrumental characterization was performed by texture profile analysis and by a special delamination test. The sensory analysis was voluntarily conducted with an untrained panel as blind test to confirm or reverse the possible interplay. The two approaches or methods gave the same type of classification. The high-fat lipstick had the worst behaviour with the delamination test and the worst notation of the intensity of descriptors with the sensory analysis. There is a high correlation between the sensory analysis and the instrumental measurements in this study. The delamination test carried out should permit to quickly determine the lasting (screening test) and in consequence optimize the basic formula of lipsticks.

Standardisation of the FAERS database: a systematic approach to manually recoding drug name variants

The US Food and Drug Administration Adverse Event Reporting System (FAERS), one of the world's largest spontaneous reporting systems, is difficult to use because of report duplication and a lack of standardisation in the recording of drug names. Unresolved data quality issues may distort statistical analyses, rendering the results difficult to interpret when detecting and monitoring adverse effects of pharmaceutical products. The aim of this study was to develop and implement a data cleaning protocol to identify and resolve drug nomenclature issues. The key 'data treatment' plan involved standardising drug names held in the FAERS database. Four million five hundred and six thousand five hundred and seventy-seven. Individual Safety Reports submitted to the FAERS between 1 January 2003 and 31 August 2012 were included for this study. OpenRefine was used to standardise drug name variants in the database such that they were consistent with international non-proprietary nomenclature defined by the World Health Organisation Anatomical Therapeutic Chemical classification. Drug variants where generic constituents could not be confidently determined, undecipherable drug names and non-medicinal products were retained verbatim. After the standardisation process, more than 16 611 916 drug entries were cleaned to their relevant international non-proprietary name. The cleaned drug table comprised 71 858 drug name variants and includes both standardised and original terms. Ninety-nine per cent of drug names was standardised using this method. The millions of reports enclosed in the FAERS contain valuable information that is of interest to pharmacovigilance, toxicology and post-marketing surveillance researchers. With the standardisation of the drug nomenclature, the database can be better utilised by research groups around the world.

Characterization of the Glycosyltransferase Gene UGT78H2 from Blackberry and Docking with Flavonoid Molecules

Glycosylation plays a pivotal role in determining the diversities of plant small molecules.Glycosyltransferases are ubiquitous proteins involved in such reactions. However,the exact mechanisms of sugar donor or acceptor substrate recognition are still to be elusive. We reported the isolation of a new glycosyltransferase gene from blackberry plants( Rubus spp.),nominated as UGT78H2( Gen Bank Accession No. : KM061379) by the international UDP Glucosyltransferase Nomenclature Committee. The full length of the gene contained an open reading frame of 1 380 nucleotides,encoding a 50. 6 k D polypeptides of 459 amino acids. By further analysis,the deduced enzyme was a typical family-1 glucosyltransferase with the plant secondary product glucosyltransferase signature motif in the C terminal. Phylogenetic trees revealed the clustering of UGT78H2 in the F node together with other Arabidopsis thaliana GTs,inferring the possible catalysis activity toward flavonoid compounds. Amino acids of UGT78H2 shared most,but only 88% identity to the Rh UF3GT( UGT78H1) in Rose hybrid when aligned to other glycosyltransferases. Most abundant transcripts of the gene were observed in the immature blackberry fruits,a stage when little anthocyanins were produced.Additionally,transcription levels decreased dramatically with the maturation of fruits. We used the Medicagotruncatula UGT78G1( PDB: 3HBF) as a template to homologically model the protein of UGT78H2 that was subsequently docked with 12 common flavonoid molecules. UGT78H2 was predicted to be a glucosyltransferase having maximum binding affinity towards quercetin,tangeritin and epicatechin.

A Discussion on Non-coking Coal Pricing Systems Adopted in Different Countries

Coal is a critical input for power, fertilizer, iron and steel (I&S) and the cement sector. At times up to 75 per cent of the power generated in India is coal fired.1 Besides being used on a large scale as domestic and eateries fuel, coal also plays an important role in paper, brick kiln and chemical industries. Except for I&S, every other consumer uses coal primarily for its inherent thermal properties, that is, heat generated during combustion. That precisely is the reason why in international nomenclature, the terminology non-coking coal has been replaced by thermal coal. Apart from combustible material, coal also contains noncombustible impurities and is represented essentially by its ash content. Ash is the solid incombustible residue obtained after burning the coal. Moisture content is another negative quality parameter of coal. It could be either inherently present in coal or could get added during mining, cleaning, transport, stock-piling, etc. Coal price and pricing and its socio-economic impact have become a major subject of concern and therefore for debate in recent times. For the first time in the modern history of India, coal has become an important political issue. Coal consumers in India believe that total moisture content in the coal used by them quite often is rather unreasonably high. All other negative quality parameters of coal, physical or chemical in nature, are in some or the other way associated with the ash content and ash composition of coal.

Central nervous system vasculitis according to the 2012 revise international Chapel Hill consensus conference nomenclature of vasculitides

Vasculitis can be primarily or secondarily to various underlying diseases. It frequently affects the nervous system, and neurological deficits may remain even after disease remission. Because the progression of vasculitides is usually acute to subacute, early initiation of treatment is important from the viewpoint of patients' functional status. However, early diagnosis may be difficult, particularly in patients with central nervous system vasculitis. Hence, it is important to understand the wide-ranging clinical manifestations of vasculitides. Here, we summarize the 2012 revised International Chapel Hill Consensus Conference nomenclature of vasculitides from the standpoint of central nervous system vasculitis.

Naturally toxic: natural substances used in personal care products

Nature offers an incredible diversity of chemical compounds that boast a wide array of physiological effects. Many natural substances are employed in personal care products. Which of these natural substances are hazardous ingredients? How do European legal instruments regulate natural substances with toxic effects? 1,358 natural substances appear in the ‘International Nomenclature of Cosmetic Ingredients’ (INCI list, ‘inventory …… of ingredients employed in cosmetic products’) [Commission Decision 96/335/EC], most of them are herbal products, others are of animal, fungal, or bacterial origin. Out of these, 655 natural substances are enrolled in the EU database for classification and labeling, with 56% classified as hazardous chemicals, 38% classified due to their hazards to human health (35% due to their effects on skin and eyes), and 21% due to their hazards to the environment. 53 natural substances in the INCI list are classified as carcinogens, mutagens, and substances toxic to reproduction. Many classifications are not in line with expectations from experience, such as severe classifications of substances derived from some basic food plants or lacking classification of known medical plants or plants with sensitizing potential. Classification and labeling is a trigger for the registration requirements according to REACH. It must be assumed that there are more substances that should undergo the REACH process among the 703 natural substances that do not turn up in the C&L inventory. Many natural substances used in personal care products have toxic properties. The interdisciplinary compilation and analysis of regulatory instruments concerning natural substances revealed some inconsistencies which need further analysis and urgent correction to ensure prudent handling in consumer products.

Targeting the Mitotic Catastrophe Signaling Pathway in Cancer.

Mitotic catastrophe, as defined in 2012 by the International Nomenclature Committee on Cell Death, is a bona fide intrinsic oncosuppressive mechanism that senses mitotic failure and responds by driving a cell to an irreversible antiproliferative fate of death or senescence. Thus, failed mitotic catastrophe can promote the unrestrained growth of defective cells, thereby representing a major gateway to tumour development. Furthermore, the activation of mitotic catastrophe offers significant therapeutic advantage which has been exploited in the action of conventional and targeted anticancer agents. Yet, despite its importance in tumour prevention and treatment, the molecular mechanism of mitotic catastrophe is not well understood. A better understanding of the signals that determine cell fate following failed or defective mitosis will reveal new opportunities to selectively target and enhance the programme for therapeutic benefit and reveal biomarkers to predict patient response. This review is focused on the molecular mechanism of mitotic catastrophe induction and signalling and highlights current strategies to exploit the process in cancer therapy.

Prediction of genotoxic potential of cosmetic ingredients by an in silico battery system consisting of a combination of an expert rule-based system and a statistics-based system.

Genotoxicity is the most commonly used endpoint to predict the carcinogenicity of chemicals. The International Conference on Harmonization (ICH) M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk offers guidance on (quantitative) structure-activity relationship ((Q)SAR) methodologies that predict the outcome of bacterial mutagenicity assay for actual and potential impurities. We examined the effectiveness of the (Q)SAR approach with the combination of DEREK NEXUS as an expert rule-based system and ADMEWorks as a statistics-based system for the prediction of not only mutagenic potential in the Ames test, but also genotoxic potential in mutagenicity and clastogenicity tests, using a data set of 342 chemicals extracted from the literature. The prediction of mutagenic potential or genotoxic potential by DEREK NEXUS or ADMEWorks showed high values of sensitivity and concordance, while prediction by the combination of DEREK NEXUS and ADMEWorks (battery system) showed the highest values of sensitivity and concordance among the three methods, but the lowest value of specificity. The number of false negatives was reduced with the battery system. We also separately predicted the mutagenic potential and genotoxic potential of 41 cosmetic ingredients listed in the International Nomenclature of Cosmetic Ingredients (INCI) among the 342 chemicals. Although specificity was low with the battery system, sensitivity and concordance were high. These results suggest that the battery system consisting of DEREK NEXUS and ADMEWorks is useful for prediction of genotoxic potential of chemicals, including cosmetic ingredients.

Development of QSAR models using artificial neural network analysis for risk assessment of repeated-dose, reproductive, and developmental toxicities of cosmetic ingredients.

Use of laboratory animals for systemic toxicity testing is subject to strong ethical and regulatory constraints, but few alternatives are yet available. One possible approach to predict systemic toxicity of chemicals in the absence of experimental data is quantitative structure-activity relationship (QSAR) analysis. Here, we present QSAR models for prediction of maximum "no observed effect level" (NOEL) for repeated-dose, developmental and reproductive toxicities. NOEL values of 421 chemicals for repeated-dose toxicity, 315 for reproductive toxicity, and 156 for developmental toxicity were collected from Japan Existing Chemical Data Base (JECDB). Descriptors to predict toxicity were selected based on molecular orbital (MO) calculations, and QSAR models employing multiple independent descriptors as the input layer of an artificial neural network (ANN) were constructed to predict NOEL values. Robustness of the models was indicated by the root-mean-square (RMS) errors after 10-fold cross-validation (0.529 for repeated-dose, 0.508 for reproductive, and 0.558 for developmental toxicity). Evaluation of the models in terms of the percentages of predicted NOELs falling within factors of 2, 5 and 10 of the in-vivo-determined NOELs suggested that the model is applicable to both general chemicals and the subset of chemicals listed in International Nomenclature of Cosmetic Ingredients (INCI). Our results indicate that ANN models using in silico parameters have useful predictive performance, and should contribute to integrated risk assessment of systemic toxicity using a weight-of-evidence approach. Availability of predicted NOELs will allow calculation of the margin of safety, as recommended by the Scientific Committee on Consumer Safety (SCCS).

A cosmeceutical formulation based on boswellic acids for the treatment of erythematous eczema and psoriasis.

BackgroundBoswellic acids (BAs) show anti-inflammatory properties in a variety of inflammatory diseases, including rheumatoid arthritis, osteoarthritis, and asthma. A topical administration route is currently used to deliver active compounds in psoriatic and eczematous patients. In this double-blind study we compare a novel BA formulation (containing Bosexil®, INCI [International Nomenclature of Cosmetic Ingredients]: lecithin, Boswellia serrata resin extract) with a placebo formulation. A third arm of the trial received a formulation of Vaccinium myrtillus seed oil, previously demonstrated as an effective local treatment for psoriatic lesions.MethodsPatients with psoriasis or erythematous eczema were randomly assigned, in a 1:1:1 ratio, to Bosexil®, V. myrtillus seed oil, or placebo. In order to evaluate the effects of treatment, the changes of scales and erythema from diagnosis to the end of treatment were scored in psoriatic patients, while changes in itch and erythema were analyzed for erythematous eczema patients. Psoriasis Area Severity Index and Eczema Area and Severity Index scores were also calculated.ResultsIn patients with psoriasis, scales and erythema improved both with Bosexil® and the V. myrtillus seed oil treatment in comparison with placebo. In particular, the treatment with Bosexil® formulation improved scales (70% of cases) and erythema (50% of cases) without any case of worsening. In patients with eczema, the administration of placebo did not result in any improvement in 90% of cases, and in the remaining 10% worsened both itch and erythema. Bosexil® formulation improved both itch (60% of cases) and erythema (60% of cases) without any case of worsening. V. myrtillus seed oil improved itch and erythema in 66.7% and 77.8% of patients, respectively.ConclusionA topical formulation of Bosexil® may be promising for the treatment of psoriasis and erythematous eczema. Long-term studies are recommended to evaluate the adherence to this topical treatment and its clinical benefits in real life.

The frontal branch of the facial nerve: can we define a safety zone?

The temporal branch of the facial nerve, a particularly important branch in facial expression, is commonly exposed to surgical trauma. The frontal branch is the most important branch of the temporal branch in the clinical point of view. However, it does not really define in the international nomenclature. The objective of this study was to clearly identify this branch, to perform a cartography of the crossing areas of this branch; and therefore to define statistically a zone of safety within the fronto-temporal region. We used 12 fresh cadavers to perform 24 facial nerve dissections. After the identification of the facial nerve, the branches of the temporofacial trunk were identified, dissected and followed till their penetration. We measured the relationship of the frontal branch with the zygomatic arch, temporal vessels and lateral border of the orbit. We conducted a statistical study to assess the risk of injury of this branch within the temporal region. We observed an important variability in the distribution of this branch in the temporal region. We defined three zones of decreasing safety at the level of three interest landmarks: at the level of the inferior part of the zygomatic arch, we estimated an elevated risk of nerve injury (>85%) from 22.6 to 26.06 mm in front of the tragus; at the level of the superior part of the zygomatic arch, we estimated an elevated risk of nerve injury (>85%) from 27.46 to 30.43 mm in front of the tragus; at the level of the lateral border of the orbit, we estimated an elevated risk of nerve injury (>85%) from 16.20 to 19.17 mm behind this landmark. There exists no real area of anatomical safety in the temporal region. It seems, however, possible to define areas of relative safety that would be of great help for the surgeon or the morphologist wishing to approach pathologies of this region.

Melatonin in sperm biology: breaking paradigms.

Melatonin is a ubiquitous molecule, present in a wide range of organisms, and involved in multiple functions. Melatonin relays the information about the photoperiod to the tissues that express melatonin-binding sites in both central and peripheral nervous systems. This hormone has a complex mechanism of action. It can cross the cell plasma membrane and exert its actions in all cells of the body. Certain melatonin actions are mediated by receptors that belong to the superfamily of G-protein-coupled receptors (GPCRs), the MT1 and MT2 membrane. Melatonin can also bind to calmodulin as well as to nuclear receptors of the retinoic acid receptor family, RORα1, RORα2 and RZRβ. The purpose of this review is to report on recent developments in the physiological role of melatonin and its receptors. Specific issues concerning the biological function of melatonin in mammalian seasonal reproduction and spermatozoa are considered. The significance of the continuous presence of melatonin in seminal plasma with a fairly constant concentration is also discussed.

Coding 299 fetal hearts scans using one single item from ACC-CHD and IPCCC lists: Limits, results, and comparison of discordances related to professional experience

The international nomenclature of Congenital Heart Diseases (CHD) remains challenging. Classifications have been proposed such as the International Pediatric and Congenital Cardiac Code (IPCCC) and the ACC-CHD (Anatomic and Clinical Classification). We retrospectively included all consecutive fetal echocardiograms (1 cardiologist) over 6 years. Reports were independently coded with 1 single code (the most precise) by 3 pediatric cardiologists with increasing experience (junior [J], senior I [SI] and II [SII]). Discordances between doctors were compared to a gold standard code secondary fixed by SI and SII, with focus on coding difficulties and effects of professional experience using IPCCC and ACC-CHD. Among 299 scans, 7 were excluded (doubts). Coding was always possible with IPCCCC, but not achieved in 112 cases with ACC-CHD. One hundred and eighty hearts were selected. Using either IPCCC or ACC-CHD, coding with 1 item was difficult for SI and SII in 15% of cases (ACC-CHD categories 6, 9, 8). IPCCC was too exhaustive for its simple use leading to discordance. ACC-CHD was also difficult to use (learning curve, use of 1 code, complex CHD). Coding discordance using ACC-CHD main categories was higher for junior compared to seniors (J-SI, P = 0.04; J-SII, P = 0.02), without difference between seniors. Compared to the gold standard for ACC-CHD (main, sub) categories, junior concordance was lower (73.3%, 71.1%) than SI (90%, 83.3%, P < 0.005) and SII (88.3%, 87.2%, P < 0.0001). Senior concordance was stronger (75%) with ACC-CHD sub categories compared to IPCCC (65%, P = 0.028). IPCCC and ACC-CHD remain difficult for their use in clinical practice. Many functional abnormalities are not listed in the ACC-CHD but could be updated with a few more sub groups. The use of 1 code appears restrictive to well classify some complex CHD and limits our study. However, we believe that some ACC-CHD categories allow simplification with prognosis issues for further studies.

Y-SNP analysis versus Y-haplogroup predictor in the Slovak population.

Human Y-chromosome haplogroups are important markers used mainly in population genetic studies. The haplogroups are defined by several SNPs according to the phylogeny and international nomenclature. The alternative method to estimate the Y-chromosome haplogroups is to predict Y-chromosome haplotypes from a set of Y-STR markers using software for Y-haplogroup prediction. The purpose of this study was to compare the accuracy of three types of Y-haplogroup prediction software and to determine the structure of Slovak population revealed by the Y-chromosome haplogroups. We used a sample of 166 Slovak males in which 12 Y-STR markers were genotyped in our previous study. These results were analyzed by three different software products that predict Y-haplogroups. To estimate the accuracy of these prediction software, Y-haplogroups were determined in the same sample by genotyping Y-chromosome SNPs. Haplogroups were correctly predicted in 98.80% (Whit Athey's Haplogroup Predictor), 97.59% (Jim Cullen's Haplogroup Predictor) and 98.19% (YPredictor by Vadim Urasin 1.5.0) of individuals. The occurrence of errors in Y-chromosome haplogroup prediction suggests that the validation using SNP analysis is appropriate when high accuracy is required. The results of SNP based haplotype determination indicate that 39.15% of the Slovak population belongs to R1a-M198 lineage, which is one of the main European lineages.

Do lipids influence the allergic sensitization process?

Allergic sensitization is a multifactorial process that is not only influenced by the allergen and its biological function per se but also by other small molecular compounds, such as lipids, that are directly bound as ligands by the allergen or are present in the allergen source. Several members of major allergen families bind lipid ligands through hydrophobic cavities or electrostatic or hydrophobic interactions. These allergens include certain seed storage proteins, Bet v 1–like and nonspecific lipid transfer proteins from pollens and fruits, certain inhalant allergens from house dust mites and cockroaches, and lipocalins. Lipids from the pollen coat and furry animals and the so-called pollen-associated lipid mediators are codelivered with the allergens and can modulate the immune responses of predisposed subjects by interacting with the innate immune system and invariant natural killer T cells. In addition, lipids originating from bacterial members of the pollen microbiome contribute to the outcome of the sensitization process. Dietary lipids act as adjuvants and might skew the immune response toward a TH2-dominated phenotype. In addition, the association with lipids protects food allergens from gastrointestinal degradation and facilitates their uptake by intestinal cells. These findings will have a major influence on how allergic sensitization will be viewed and studied in the future.

Proposed Lexicon for Anatomic Landmarks in Normal Posterior Segment Spectral-Domain Optical Coherence Tomography: The IN•OCT Consensus

To develop a consensus nomenclature for the classification of retinal and choroidal layers and bands visible on spectral-domain optical coherence tomography (SD-OCT) images of a normal eye. An international panel with expertise in retinal imaging (International Nomenclature for Optical Coherence Tomography [IN • OCT] Panel) was assembled to define a consensus for OCT imaging terminology. A panel of retina specialists. A set of 3 B-scan images from a normal eye was circulated to the panel before the meeting for independent assignment of nomenclature to anatomic landmarks in the vitreous, retina, and choroid. The outputs were scrutinized, tabulated, and used as the starting point for discussions at a roundtable panel meeting. The history of anatomic landmark designations over time was reviewed for the various cellular layers of the ocular structures that are visible by SD-OCT. A process of open discussion and negotiation was undertaken until a unanimous consensus name was adopted for each feature. Definitions of normal eye features showed by SD-OCT. Definitions for various layers changed frequently in the literature and were often inconsistent with retinal anatomy and histology. The panel introduced the term "zone" for OCT features that seem to localize to a particular anatomic region that lacks definitely proven evidence for a specific reflective structure. Such zones include the myoid, ellipsoid, and the interdigitation zones. A nomenclature system for normal anatomic landmarks seen on SD-OCT outputs has been proposed and adopted by the IN • OCT Panel. The panel recommends this standardized nomenclature for use in future publications. The proposed harmonizing of terminology serves as a basis for future OCT research studies.