Development of a Korean version of simple, intuitive descriptions for clinical use of the generic functioning domains in the ICD-11 Chapter V.

PURPOSE: To develop a Korean version of simple, intuitive descriptions (SIDs) for clinical use of the generic functioning domains in the International Classification of Disease 11th revision (ICD-11) Chapter V. METHODS: The initial Korean SID version proposal for the International Classification of Functioning, Disability, and Health (ICF) Rehabilitation set was translated following the Italian version. The remaining 17 codes were developed using original ICF descriptions; WHO Disability Assessment Schedule, Model Disability Survey, Korean Classification of Functioning, Disability, and Health; and previous studies. The final proposal for the Korean version of SIDs was selected through virtual conferences and three rounds of voting. RESULTS: This study developed SIDs for the 47 generic functioning domains in the Chapter V of ICD-11. However, the SID for 20 of the 47 codes was confirmed in vote A, for 23 codes in vote B and for the remaining 4 in the final vote. All experts agreed with the final SID proposal. CONCLUSIONS: This is the first study in South Korea to attempt the development of SIDs for ICD-11 Chapter V. Therefore, the findings of this study could be used to evaluating of disability, functioning when ICD-11 is adopted for use in Korean clinical settings.

Simple, intuitive descriptions (SIDs) highlight the core concepts of the ICF category definitions in a user-friendly manner and enhance the utility of the ICF for routine clinical practice.The 11^th revision of the International Classification of Disease (ICD-11) was developed in 2019 with the addition of Chapter V which reflects functioning domains and better explains the association between functioning and disease.In addition, Chapter V is based on ICF, so the concept of ICF must be included, and concept definition is required for use in clinical practice.This study developed a Korean version of SIDs for clinical use of the generic functioning domains in the ICD-11 Chapter V.

Method for determination of elemental impurities in metronidazole benzoate using inductively coupled plasma mass spectrometry.

The elemental impurities in pharmaceutical products have aroused widespread concern among respective supervising authorities and official pharmacopoeias since they are harmful and have no therapeutic effects. Metronidazole benzoate is used extensively to treat a variety of infections. However, impurities will inevitably be introduced in the manufacturing process of metronidazole benzoate. Hence, in this study, a sensitive method was developed for trace determination of elemental impurities in metronidazole benzoate active pharmaceutical ingredients by using inductively coupled plasma mass spectrometry in kinetic energy discrimination mode. The method was validated for system suitability, specificity, linearity, sensitivity, accuracy, and precision according to USP chapter <233> Elemental Impurities-Procedure. The method had good linearity with correlation coefficients > 0.99. The limits of detection were in the range of 0.0003-0.1411 µg/g, which was lower than the acceptable limit and indicated the high sensitivity of the method. The method was accurate with the recoveries in the range of 92%-107%. Moreover, the content of seven elemental impurities in the three batches of metronidazole benzoate active pharmaceutical ingredients by this method was originally below their limits and less than 30% of permitted daily exposure, meeting the requirement of International Council for Harmonization Q3D guidelines. Thus, this newly developed and validated method for estimating elemental impurities in metronidazole benzoate active pharmaceutical ingredients was within the permitted limit and suitable for routine use.

Informal investigation on the added value of a potential certification system for the qualification of raw materials for the production of ATMPs.

The manufacture of advanced therapy medicinal products (ATMPs) is critically impacted by the quality of the raw materials (RMs) used. Following the need expressed by stakeholders to establish a certification scheme for biological RMs used in the manufacture of ATMPs, the European Pharmacopoeia (Ph. Eur.) Cell Therapy Products Working Party (CTP WP) conducted an informal investigation with the aim of issuing a technical opinion on the feasibility of such a certification scheme. Seven RM Drug Master Files were reviewed for compliance of the RM with Ph. Eur. general chapter 5.2.12. Raw materials of biological origin for the production of cell-based and gene therapy medicinal products by members of the CTP WP who were representatives of competent authorities and experienced in the evaluation of RMs for ATMPs. This article presents the results of these case studies, including the potential benefits and concerns identified by the experts. It was concluded that it would be technically feasible, albeit challenging, to set up a certification system for RMs of biological origin against chapter 5.2.12. Although the establishment of such a scheme is currently perceived by some CTP WP members as premature, it could potentially be beneficial for all stakeholders (RM manufacturers, ATMP manufacturers and assessors).

Weighing according to the European Pharmacopoeia: general considerations and new general chapter 2.1.7. Balances for analytical purposes.

Weighing is a key activity in every quality control laboratory as it is one of the first steps in the preparation of samples and reagents for most analytical procedures. It is also critical because weighing errors will add up and propagate throughout the whole analysis, affecting the accuracy and precision of the reported results. A new general chapter, Balances for analytical purposes (2.1.7), has recently been published in the European Pharmacopoeia (Ph. Eur.). This new text sets out clear requirements for an instrument that is essential to every analytical procedure described within the pages of the Ph. Eur. This article explains in detail these requirements and generally reviews the other quantity-related requirements present in Ph. Eur. texts.

The enforceability of the trade and sustainable development chapters of the European Union's free trade agreements.

Since 2011, the European Union's (EU) free trade agreements (FTAs) include a Trade and Sustainable Development (TSD) chapter which provides for environmental and labour commitments. Nevertheless, the ratification and implementation of these commitments remain insufficient. It is therefore essential to analyse whether the EU has become more ambitious in enforcing the TSD chapter. To analyse the chapter's enforceability, the EU's FTAs with South Korea, Canada and Japan have been compared. The comparative analysis was based on three elements: the labour and environmental commitments, institutional mechanisms and the enforcement procedure. Concerning the latter, the ongoing EU-Korea dispute settlement case over workers' rights in South Korea is the leading example. Until the Commission reveals more assertive enforcement plans, it can be said that the EU has not become more ambitious in enforcing its TSD chapter. Since no major changes were detected in the comparative analysis, several interviewees proposed enforcement mechanisms.

Worldwide initiatives aimed to train professionals in the use of the ICD-11.

BACKGROUND: The chapter on mental disorders of the 11th revision of the International Classification of Diseases (ICD-11) has been now finalized. Training of mental health professionals in the use of the chapter is taking place worldwide. Information is provided on the ICD-11 training courses taking place recently, including that co-organized by the Naples World Health Organization (WHO) Collaborating Centre on Research and Training in Mental Health and the European Psychiatric Association; those which will be held in the next few months, such as the one co-organized by the World Psychiatric Association and the Global Mental Health Academy, to be held online from 8 to 29 November 2021; and the training course set up by the WHO Collaborating Centre on Mental Health at the Columbia University, in collaboration with the WHO Department of Mental Health and Substance Use, which can be accessed only by the members of the WHO Global Clinical Practice Network. CONCLUSION: Psychiatrists of all countries of the world are encouraged to become familiar with the ICD-11 chapter on mental disorders, which will be adopted shortly by most countries worldwide.

Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review.

The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People's Republic of China in July 2020. The current edition was officially implemented on December 30, 2020. The general chapters of the Chinese Pharmacopoeia discuss the general testing methods and guidelines, which are the common requirements and basis for the implementation of drug standards in the Chinese Pharmacopoeia. Owing to adherence to the principles of scientificity, versatility, operability, and sustainable development, there is an improvement in the general chapters of the 2020 edition over those of the previous editions. Further, the application of advanced and mature analytical techniques has expanded, the development of testing methods for exogenous pollutants in traditional Chinese medicines has been strengthened, and technical requirements are now better harmonized with international standards. The updated edition provides technical and methodological support to ensure safety, effectiveness, and control of pharmaceuticals in China and will play an important and active role in encouraging the application of advanced technologies, improving the quality control of medicines, and strengthening the means of drug regulation in China. This review provides a comprehensive introduction of the main features of and changes to the general chapters in the Chinese Pharmacopoeia 2020 edition and aims to provide reference for its correct understanding and accurate implementation.

Modifications of the U.S. food and drug administration validated method for detection of Cyclospora cayetanensis oocysts in prepared dishes: Mexican-style salsas and guacamole.

Although multiple outbreak clusters of Cyclospora cayetanensis have been traced back to consumption of dishes in Mexican-style restaurants, the FDA Bacteriological Analytical Manual (BAM) does not currently provide methods to detect C. cayetanensis in dishes that contain multiple produce ingredients, such as salsas and guacamole. These complex food matrices also may contain high levels of fats, which can interfere with the detection. Several modifications to the BAM Chapter 19b method (washing produce, DNA extraction, and a TaqMan real-time PCR assay targeting the 18S rRNA gene of C. cayetanensis) were assessed with the goal to detect as few as 5 oocysts of C. cayetanensis in 25 g samples of commercial salsa/pico de gallo, guacamole, and salsa verde. Both freshly prepared and frozen versions of these foods were seeded with 5, 10 and 200 oocysts. For salsa samples, using a gentler washing step than recommended by BAM, we achieved detection of 5 oocysts in the samples (81.8%, n = 11). Increasing the amount of Alconox® in the wash solution to 1%, rather than the 0.1% used in BAM, and adjusting the DNA extraction protocol to process large wash pellets, enabled detection of 5 oocysts in guacamole. To reach the desired level of detection in salsa verde, two types of modifications were necessary: gentler washing and DNA extraction modifications. The use of these same method modifications on previously frozen food samples, provided levels of detection similar to those achieved with fresh dishes. Our modifications enabled robust and reproducible detection of C. cayetanensis in multi-ingredient Mexican dishes, detecting as few as 5 oocysts in 25 g samples. Validating and deploying effective methods to detect C. cayetanensis in high risk fresh produce and prepared dishes are critically important for prevalence studies and outbreak investigations of this parasite.

Development of the general chapters of the Chinese Pharmacopoeia 2020 edition:A review / 药物分析学报

The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People's Republic of China in July 2020.The current edition was officially implemented on December 30,2020.The general chapters of the Chinese Pharmacopoeia discuss the general testing methods and guidelines,which are the common re-quirements and basis for the implementation of drug standards in the Chinese Pharmacopoeia.Owing to adherence to the principles of scientificity,versatility,operability,and sustainable development,there is an improvement in the general chapters of the 2020 edition over those of the previous editions.Further,the application of advanced and mature analytical techniques has expanded,the development of testing methods for exogenous pollutants in traditional Chinese medicines has been strengthened,and technical requirements are now better harmonized with international standards.The updated edition provides technical and methodological support to ensure safety,effectiveness,and control of pharmaceuticals in China and will play an important and active role in encouraging the application of advanced technolo-gies,improving the quality control of medicines,and strengthening the means of drug regulation in China.This review provides a comprehensive introduction of the main features of and changes to the general chapters in the Chinese Pharmacopoeia 2020 edition and aims to provide reference for its correct understanding and accurate implementation.

Procedures and timetable for proposals to amend Chapter F of the International Code of Nomenclature for algae, fungi, and plants.

Procedures for preparing and submitting proposals to amend or enhance Chapter F of the International Code of Nomenclature for algae, fungi, and plants are provided. Such proposals will be considered by the Fungal Nomenclature Session of the XII International Mycological Congress to he held in Amsterdam in 2022. A timetable is laid out for the submission of proposals, due by 31 December 2021, their publication in IMA Fungus, the appearance of the 'Synopsis of proposals" and the conduct of the pre-Congress guiding vote.

Assessment of Commercial DNA Cleanup Kits for Elimination of Real-Time PCR Inhibitors in the Detection of Cyclospora cayetanensis in Cilantro.

ABSTRACT: Inhibited reactions have occasionally been observed when cilantro samples were processed for the detection of Cyclospora cayetanensis using quantitative real-time PCR (qPCR). Partial or total inhibition of PCR reactions, including qPCR, can occur, leading to decreased sensitivity or false-negative results. If inhibition occurs, this implies the need for additional purification or cleanup treatments of the extracted DNA to remove inhibitors prior to molecular detection. Our objective was to evaluate the performance of five commercial DNA cleanup kits (QIAquick purification kit from Qiagen [kit 1], OneStep PCR inhibitor removal by Zymo Research [kit 2], NucleoSpin genomic DNA cleanup XS from Macherey-Nagel [kit 3], DNA IQ system by Promega [kit 4], and DNeasy PowerPlant pro kit from Qiagen [5]) to minimize qPCR inhibition using the U.S. Food and Drug Administration-validated Bacteriological Analytical Manual (BAM) Chapter 19b method for detection of C. cayetanensis in cilantro samples containing soil. Each of the five commercial DNA cleanup kits evaluated was able to reduce the qPCR internal amplification control cycle threshold values to those considered to be normal for noninhibited samples, allowing unambiguous interpretation of results in cilantro samples seeded at both a high oocyst level (200 oocysts) and a low oocyst level (10 oocysts). Of the five kits compared, kits 1, 2, and 3 did not show significant differences in the detection of C. cayetanensis, while significantly higher cycle threshold values, indicating lower recovery of the target DNA, were observed from kits 4 and/or 5 in samples seeded with 200 and 10 oocysts (P < 0.05). This comparative study provides recommendations on the use of commercial cleanup kits which could be implemented when inhibition is observed in the detection of C. cayetanensis in cilantro samples using the BAM Chapter 19b method.

Nutritional Lipidomics in Alzheimer's Disease.

Lipids constitute almost 60% of the brain's dry weight, and they are thought to be involved in inflammation, neurotransmission and synaptic plasticity. The brain mostly contains sphingolipids, glycerophospholipids and cholesterol which are abundant in myelin and neuronal membranes. The recent rise of the promising area of lipidomic data can be used as a diagnosing tool at the early stages of Alzheimer's disease allowing novel therapeutic targets. In this review, altered lipid metabolites as well as the impact of diet in the progress of Alzheimer's disease (AD) are analyzed.

A Proposed Revision of the International Classification of Diseases, 11th Revision, Chapter 26.

In 2019, the World Health Assembly approved the International Classification of Diseases, 11th Revision (ICD-11), which included a traditional medicine chapter. This means that traditional medicine (TM) is incorporated into the mainstream medicine of the world. For TM to contribute to human health, the role of ICD-11, chapter 26 (ICD-11-26), is important. Since the ICD-11-26 is "a union set of harmonized traditional medicine conditions of the Chinese, Japanese, and Korean classifications," it is advisable to supplement the essential patterns while maintaining the already adopted patterns. The ICD-11-26 was originated from the World Health Organization International Standard Terminologies on Traditional Medicine in the Western Pacific Region (WHO-IST), and the WHO-IST is the world's most authoritative TM standard terminology system with an emphasis on traditional and conventional expression. In addition, it includes patterns that are widely used in TM clinical practice and have representative prescriptions at the same time. Therefore, future revisions of ICD-11-26 should make WHO-IST the main reference. Based on this spirit, this proposed revision is a modification of ICD-11-26's structure, order, and expression (English translation) with more essential patterns.

Development and Revision of the General Principles of Physical and Chemical Analysis in the Chinese Pharmacopoeia 2020 Edition Volume / 中国药学杂志

OBJECTIVE: To provide references for the correct understanding and accurate implementation of the physical and chemical analysis general chapters of the Chinese Pharmacopoeia 2020 Edition volume . METHODSE: The principles, processes, and main considerations of the development of the physical and chemical analysis general chapters of the Chinese Pharmacopoeia 2020 edition volume IV are introduced, and the content and main characteristics are summarized and analyzed. RESULTS: According to the goals and key tasks of the Chinese Pharmacopoeia 2020 edition, the principles of scientificity, versatility, operability, gradual and sustainable development, and harmonization with international standards, the physical and chemical analysis committee of the Chinese Pharmacopoeia commission carry out the development of the physical and chemical analysis general chapters of the Chinese Pharmacopoeia 2020 edition volume . Further expand the application of advanced and mature analytical techniques, strengthen the applicability of analytical methods and the development of the external pollution control methods for Chinese medicinal materials, and improve the harmonization of analytical techniques and impurity control requirements with international technical requirements. CONCLUSION: The physical and chemical analysis general chapters of Chinese Pharmacopoeia 2020 edition volume provide method and technical support to ensure the safety, effectiveness and controllable quality of China's pharmaceuticals, and play an important and positive role in encouraging the application of advanced analytical technology, strengthening drug regulatory measures, and enhancing the international influence of the Chinese Pharmacopoeia.

Theory and practice of pharmacopoeial control of quality of drugs and excipients X. Number of parallel determinations, processing of results and their use in the assessment of the content of active substances and excipients in the European Pharmacopoeia (Ph. Eur.).

In the European Pharmacopoeia (Ph. Eur.) there is no prescribed number of parallel determinations of the content of active substances and excipients. The authors suggest adding at least three determinations. The results of parallel determinations suggest to test for outliers before using test based on the ratio of the range of results (p = 0.95) and not to compare individual results with the tolerance limits given in Ph. Eur., but with their arithmetic mean. Furthermore, they propose to extend the Chapter 5.3. of the European Pharmacopoeia so as to be applicable not only to bioassays, but also to chemical, physicochemical and physical assays and tests, starting with the content of active substances and excipients.

The Human Variome Project country node of Argentina in the first two years of activity: past, present and future / El nodo Argentino del Proyecto Varioma Humano en los primeros dos años de actividad: pasado, presente y futuro

The Human Variome Project (HVP) is an international effort aiming systematically to collect and share information on all human genetic variants. It has been working for years in collaboration with local scientific societies by establishing systems to collect every genetic variant reported in a country and to store these variants within a database repository: LOVD (Argentinian chapter: ar.lovd.org). Formally established in 2017 in the Argentinian Node, up to June 2019 we collected more than 25,000 genetic variants deposited by 17 different laboratories. Nowadays the HVP country nodes represent more than 30 countries. In Latin America there are four country nodes: Argentina, Brazil, Mexico and Venezuela; the first two interacted recently launching the LatinGen database. In the present work we want to share our experience in applying the HVP project focusing on its organization, rules and nomenclature to reach the goal of sharing genetic variants and depositing them in the Leiden Open Variation Database. Contributing laboratories are seeking to share variant data to gain access all over the country. It is one of our goals to stimulate the highest quality by organizing courses, applying current nomenclature rules, sponsoring lectures in national congresses, distributing newsletter to serve the Argentinian genomics community and to stimulate the interaction among Latin America countries.

El Proyecto Varioma Humano (HVP) es un esfuerzo internacional que tiene como objetivo recopilar y compartir sistemáticamente información sobre todas las variantes genéticas humanas. Hemos estado trabajando durante tres años en colaboración con sociedades científicas locales, mediante el establecimiento de sistemas para recolectar todas las variantes genéticas reportadas en el país y almacenarlas dentro de la base de datos LOVD (capítulo argentino: ar.lovd.org). En el año 2017 fue establecido formalmente el Nodo Argentino del HVP, habiéndose recolectado más de 25.000 variantes genéticas depositadas por 17 laboratorios diferentes hasta junio de 2019. Hoy en día existen al menos 30 nodos del HVP, correspondientes a diferentes países. En América Latina hay cuatro nodos: Argentina, Brasil, México y Venezuela; Los dos primeros interactuaron recientemente lanzando la base de datos LatinGen. En el presente trabajo queremos compartir nuestra experiencia en la aplicación del proyecto HVP centrándonos en su organización, reglas y nomenclatura para alcanzar el objetivo de compartir variantes genéticas y depositarlas en la base de datos de variaciones abiertas de Leiden (LOVD). Es uno de nuestros objetivos estimular la más alta calidad mediante la organización de cursos, aplicación de las reglas de nomenclatura actuales, patrocinio de conferencias en congresos nacionales, distribución de boletines informativos para la comunidad de genómica argentina, y estimulación de la interacción entre los países de América Latina.

Chapter F of the International Code of Nomenclature for algae, fungi, and plants as approved by the 11th International Mycological Congress, San Juan, Puerto Rico, July 2018.

A revised version of Chapter F of the International Code of Nomenclature for algae, fungi, and plants is presented, incorporating amendments approved by the Fungal Nomenclature Session of the 11th International Mycological Congress held in San Juan, Puerto Rico in July 2018. The process leading to the amendments is outlined. Key changes in the San Juan Chapter F are (1) removal of option to use a colon to indicate the sanctioned status of a name, (2) introduction of correctability for incorrectly cited identifiers of names and typifications, and (3) introduction of option to use name identifiers in place of author citations. Examples have been added to aid the interpretation of new Articles and Recommendations, and Examples have also been added to the existing Art. F.3.7 concerning the protection extended to new combinations based on sanctioned names or basionyms of sanctioned names (which has been re-worded), and to Art. F.3.9 concerning typification of names accepted in the sanctioning works.