Efecto de las metodologías analíticas en la cuantificación de bitartrato de epinefrina según la USP-43 y USP-44 / Effect of analytical methodologies on the quantification of epinephrine bitartrate according to USP-43 and USP-44

Introducción: El bitartrato de epinefrina, también conocido como epinefrina, es un ingrediente farmacéutico importante en el tratamiento de diversas enfermedades, pero su medición precisa es esencial para garantizar la seguridad del medicamento. La Farmacopea de los Estados Unidos (USP) establece los estándares para su análisis, pero la elección del método afecta la precisión de las mediciones. Este estudio investiga cómo los diferentes métodos afectan la medición del bitartrato de epinefrina según las versiones USP-43 y USP-44, que tienen implicaciones significativas para la calidad y la regulación de los medicamentos en el campo. Método: Se eligieron el método volumétrico y el método cromatográfico para comparación. Se utilizaron muestras de epinefrina bitartrato de alta pureza que cumplían con los estándares de la USP-43 y USP-44.Resultados: Los resultados obtenidos por ambos métodos se comparan entre sí y se evalúan según los límites de especificación definidos por USP-43 y USP-44. Los valores obtenidos para algunos parámetros, como la concentración y la pureza del bitartrato de epinefrina, varían considerablemente entre los distintos métodos analíticos. Conclusiones: Este estudio destaca la importancia de una cuidadosa selección del método analítico al evaluar el bitartrato de epinefrina según las directrices USP-43 y USP-44. La elección de la tecnología afecta a los resultados y, por tanto, a la calidad y seguridad de los productos farmacéuticos que contienen esta sustancia. Se recomienda validar el método en cada laboratorio y comparar los resultados con los estándares USP. (AU)

Introduction: Epinephrine bitartrate, also known as epinephrine, is an important pharmaceutical ingredient in the treatment of various diseases, but its accurate measurement is essential to ensure the safety of the drug. The United States Pharmacopeia (USP) sets the standards for its analysis, but the choice of method affects the precision of the measurements. This study investigates how different methods affect the measurements of epinephrine bitartrate based on USP-43 and USP-44, which have significant implications for drug quality and regulation in the field. Method: The volumetric method and chromatographic method were chosen for comparison. High-purity epineph-rine bitartrate samples that met USP-43 and USP-44 standards were used. Results: The results obtained by both methods are compared with and evaluated according to the specification lim-its defined by USP-43 and USP-44. The values obtained for some parameters, such as the concentration and purity of epinephrine tartrate, vary considerably between the different analytical methods. Conclusions: This study highlights the importance of carefully selecting analytical methods when evaluating epi-nephrine tartrate according to USP-43 and USP-44 guidelines. The choice of technology affects the results and, therefore, the quality and safety of the pharmaceutical products containing this substance. It is recommended to validate the method in each laboratory and compare the results with USP standards. (AU)

A study on pharmaceutical text relationship extraction based on heterogeneous graph neural networks.

Effective information extraction of pharmaceutical texts is of great significance for clinical research. The ancient Chinese medicine text has streamlined sentences and complex semantic relationships, and the textual relationships may exist between heterogeneous entities. The current mainstream relationship extraction model does not take into account the associations between entities and relationships when extracting, resulting in insufficient semantic information to form an effective structured representation. In this paper, we propose a heterogeneous graph neural network relationship extraction model adapted to traditional Chinese medicine (TCM) text. First, the given sentence and predefined relationships are embedded by bidirectional encoder representation from transformers (BERT fine-tuned) word embedding as model input. Second, a heterogeneous graph network is constructed to associate words, phrases, and relationship nodes to obtain the hidden layer representation. Then, in the decoding stage, two-stage subject-object entity identification method is adopted, and the identifier adopts a binary classifier to locate the start and end positions of the TCM entities, identifying all the subject-object entities in the sentence, and finally forming the TCM entity relationship group. Through the experiments on the TCM relationship extraction dataset, the results show that the precision value of the heterogeneous graph neural network embedded with BERT is 86.99% and the F1 value reaches 87.40%, which is improved by 8.83% and 10.21% compared with the relationship extraction models CNN, Bert-CNN, and Graph LSTM.

Avicenna's pharmacopeia for the treatment of animal bites.

Envenomation is a common medical problem. The Canon of Medicine written by Avicenna is one of the reliable sources of Persian medicine. The present study aims to identify Avicenna's clinical pharmacology approach and the pharmacopeia used for the treatment of animal envenomations and also to evaluate the related data in light of the current medicine. The Canon of Medicine was searched using related Arabic keywords for the contents about the treatment of animal bites. A literature search was conducted in scientific databases including PubMed, Scopus, Google Scholar, and Web of Science to obtain relevant data. Avicenna recommended one hundred and eleven medicinal plants for the treatment of bites of vertebrate and invertebrate venomous animals including snakes, scorpions, spiders, wasps, and centipedes. He mentioned different methods of administrating these drugs including oral drugs, lotions, sprayed drugs, slow-dissolving tablets in the mouth, and enemas. Moreover, he paid special attention to pain relief in addition to specific treatments for animal bites. In the Canon of Medicine, Avicenna recommended several medicinal plants alongside analgesics for the management and treatment of animal envenomations. The current research elucidates the clinical pharmacology and pharmacopeia of Avicenna for the treatment of animal envenomations. Further research is encouraged to evaluate the efficacy of these therapeutic agents for the treatment of animal bites.

Recorrido histórico por la farmacopea de los estados unidos mexicanos. Un orgullo de la profesión farmacéutica mexicana / Historical review through the mexican united states pharmacopeia. A pride for the mexican pharmaceutical profession

Con su actual estructura la Farmacopea de los Estados Unidos Mexicanos (FEUM), ha elaborado 35 publicaciones, comenzando por las publicaciones rectoras que son la 5ª. edición en 1988, la 6ª. en 1994, la 7ª en el 2000, la 8ª en el 2004, en el 2008 la 9ª, en el 2011 la 10ª, la 11ª en 2014 y la 12ª en 2018, en 2022 se lanzó la Farmacopea de los Estados Unidos Mexicanos 13ª edición y el suplemento 13.1. en 2023. La Farmacopea Mexicana es una de las más completas del mundo, integrada por la publicación rectora que se dedica a los medicamentos alopáticos, biológicos y biotecnológicos, una publicación especializada en productos naturales, la “Farmacopea Herbolaria” que en 2021 generó la versión 3.0, la “Farmacopea Homeopática”, que en 2023 generó la versión 4.0 y el “Suplemento para Establecimientos dedicados a la venta y suministro de Medicamentos y demás Insumos para la Salud”. Su 1ª edición es de 1998 y explica las actividades del Profesional Farmacéutico en estos Establecimientos. En 2018 se publicó la 6ª edición. Una última publicación, relevante y única en el mundo, es el “Suplemento para Dispositivos Médicos”. Un Suplemento especializado que cuenta ya con alrededor de las mil quinientas páginas y que en 2023, se publicó la versión 5.0. Complementa a las publicaciones, la generación de alrededor de 100 sustancias de referencia que se utilizan para la verificación del cumplimiento de las monografías Farmacopeicas. En este artículo se presenta el recorrido histórico, de la época prehispánica, posterior a la conquista, posterior a la independencia y de la época actual, así como las modificaciones legales que han permitido alcanzar estos objetivos , bajo el trabajo y supervisión de los profesionales farmacéuticos mexicanos. (AU)

With its current structure, the Pharmacopeia of the United Mexican States (FEUM) has produced 35 publications, beginning with the leading publications, which are the 5th. Edition in 1988, the 6th. In 1994, the 7th in 2000, the 8th in 2004, the 9th in 2008, the 10th in 2011, the 11th in 2014, the 12th in 2018 and in 2022 the 13th edition and in 2023 was launched the supplement 13.1. The Mexican Pharmacopeia is one of the most complete in the world, made up the main publication dedicated to allopathic, biological and biotechnological medicines, additionally an publication specialized in natural products, the “Herbal Pharmacopeia” that in 2021 published the 3th Edition, the “Homeopathic Pharmacopeia”, which in 2023 published the 4th Edition, and the “Supplement for Establishments dedicated to the sale and supply of Medicines and other Health Supplies”. Its 1st Edition is from 1998 and explains the activities of the Pharmaceutical Professional in these Establishments. In 2018 the 6th Edition was published. One last publication, relevant and unique in the world, is the “Supplement for medical Devices”. A specialized publication that already has around 1500 pages. In 2023 was published the version 5th. Additionally to the different publication, the generation of around 100 reference substances are used to verify the compliance with Pharmacopoeia monographs. This article presents the historical review, from the pre-Hispanic era, after the conquest, after independence and the current years, as well as the legal modifications that have allowed these results to be achieved, under the scientific work and financial supervision of the Mexican pharmaceutical profession. (AU)

[Analysis and suggestions on harvest period standards of plant medicinal materials in 2020 edition of Chinese Pharmacopoeia].

The improvement of the harvest period standards is critical in the quality control of Chinese medicinal materials. The present study statistically analyzed the harvest period standards of plant medicinal materials in the 2020 edition of Chinese Pharmacopoeia(Vol.Ⅰ) and put forward the existing problems and suggestions based on herbal records and modern research to provide references for the improvement of the standards. According to the statistical analysis, in 499 types of plant medicinal materials, harvest period standards are recorded under 486 types, accounting for 97.4%, and are lacking in the remaining. Only one medicinal material(Stellariae Radix) is recorded with the standard of the harvest year. The standards of the harvest season and phenological period are recorded under 233 types, accounting for 46.7%. For 237 types, only harvest season is specified, accounting for 47.5%, and for 15 types, only harvest phenological period is specified, accounting for 3.0%. Among 222 types mainly derived from cultivation and 51 types from wild resources and cultivation, only 11 types are recorded with harvest period of cultivated products. Only Stellariae Radix is recorded with the harvest period standards for the wild and cultivated products separately. The harvest period standards of plant medicinal materials with different medicinal parts have certain rules to follow. The main problems about the harvest period standards are discovered. Specifically, no harvest period standards are recorded under 13 types of plant medicinal materials. Almost all perennial cultivated medicinal materials are not recorded with harvest year standard. No phenological period standard is found under 250 types of plant medicinal materials. There is no clear distinction between the harvest period standards of cultivated and wild products. The evidence for harvest period standards of 26 types of plant medicinal materials that can be harvested all year round is insufficient. As a result, it is proposed to strengthen basic research in response to the above-mentioned problems and improve the harvest period standards as soon as possible to ensure the quality of Chinese medicinal materials.

Analysis and suggestions on harvest period standards of plant medicinal materials in 2020 edition of Chinese Pharmacopoeia / 中国中药杂志

The improvement of the harvest period standards is critical in the quality control of Chinese medicinal materials. The present study statistically analyzed the harvest period standards of plant medicinal materials in the 2020 edition of Chinese Pharmacopoeia(Vol.Ⅰ) and put forward the existing problems and suggestions based on herbal records and modern research to provide references for the improvement of the standards. According to the statistical analysis, in 499 types of plant medicinal materials, harvest period standards are recorded under 486 types, accounting for 97.4%, and are lacking in the remaining. Only one medicinal material(Stellariae Radix) is recorded with the standard of the harvest year. The standards of the harvest season and phenological period are recorded under 233 types, accounting for 46.7%. For 237 types, only harvest season is specified, accounting for 47.5%, and for 15 types, only harvest phenological period is specified, accounting for 3.0%. Among 222 types mainly derived from cultivation and 51 types from wild resources and cultivation, only 11 types are recorded with harvest period of cultivated products. Only Stellariae Radix is recorded with the harvest period standards for the wild and cultivated products separately. The harvest period standards of plant medicinal materials with different medicinal parts have certain rules to follow. The main problems about the harvest period standards are discovered. Specifically, no harvest period standards are recorded under 13 types of plant medicinal materials. Almost all perennial cultivated medicinal materials are not recorded with harvest year standard. No phenological period standard is found under 250 types of plant medicinal materials. There is no clear distinction between the harvest period standards of cultivated and wild products. The evidence for harvest period standards of 26 types of plant medicinal materials that can be harvested all year round is insufficient. As a result, it is proposed to strengthen basic research in response to the above-mentioned problems and improve the harvest period standards as soon as possible to ensure the quality of Chinese medicinal materials.

[Detection of Residual Solvents in Commercial Supplements Using Headspace (HS)-GC-MS].

In order to understand the actual state of residual solvents contained in commercial supplements, we performed a simultaneous analysis of residual solvents by headspace (HS)-GC-MS with reference to the Japanese Pharmacopoeia's "Residual Solvents", for 29 products selected from among commercial supplements (e.g., revitalizers, weight loss pills) that are deeply colored or contain coating agents and extract powder. As a result, benzene (class 1) was detected in eight black-colored supplements, and hexane (class 2B) was also detected in one of those products. On the other hand, methanol (class 2A) was detected in four products containing coating agents and extract powders, such as citrus peel extract. None of these residual solvents exceeded the concentration limits set by the Japanese Pharmacopoeia. Benzene was detected at 1.7 µg/g, which was near the concentration limit, in some products. As raw materials used for the manufacture of the black-colored supplements from which benzene was detected commonly included activated carbon, we analyzed the residual solvents contained in activated carbon commercially available for use as food additive and in food production and medicine. As a result, benzene was detected at high concentrations in activated carbon made from hemp (approximately 29 µg/g) and bamboo (approximately 140 µg/g).

SuperTCM: A biocultural database combining biological pathways and historical linguistic data of Chinese Materia Medica for drug development.

AIM OF THE STUDY: Botanicals used in Traditional Chinese Medicine (TCM) are a rich source for drug discovery and provide models for multi-component drug development. To facilitate the studies of the actions of TCM drugs and expand their applications, a comprehensive database is urgently required. METHODS: One online resource connects all the relevant data from multiple scientific sources and languages. Drug information from published TCM databases and the official Chinese Pharmacopoeia as well as specialized meta-websites such as Kew's Medicinal Plant Names Service was integrated on a higher level. RESULTS: Our database, SuperTCM, covers the aspects of TCM derived from medicinal plants, encompassing pharmacological recipes up to chemical compounds. It provides the information for 6516 TCM drugs (or "herbs") with 5372 botanical species, 55,772 active ingredients against 543 targets in 254 KEGG pathways associated with 8634 diseases. SuperTCM is freely available at http://tcm.charite.de/supertcm.

Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group.

Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the pharmaceutical quality environment. Globalization of the pharmaceutical industry, increasingly rapid development of novel therapies, and adoption of new manufacturing techniques have presented numerous challenges for the established regulatory framework and quality environment and are impacting the approaches utilized to ensure the quality of pharmaceutical products. Regulators, industry, and standards-setting organizations have begun to recognize the need to rely more on integrated risk-based approaches and to create more nimble and flexible standards to complement these efforts. They also increasingly have recognized that quality needs to be built into systems and processes throughout the lifecycle of the product. Moreover, the recent COVID-19 crisis has emphasized the need to adopt practices that better promote global supply chain resilience. In this paper, the USP Quality Advisory Group explores the various paradigm shifts currently impacting pharmaceutical quality and the approaches that are being taken to adapt to this new environment. Broad adoption of the Analytical Procedure Lifecycle approach, improved data management, and utilization of digital technologies are identified as potential solutions that can help meet the challenges of these quality paradigm shifts. Further discussion and collaboration among stakeholders are needed to pursue these and other solutions that can ensure a continued focus on quality while facilitating pharmaceutical innovation and development.

Discrepancies in the German Pharmacopoeia procedure for quality control of Quillaja saponin extracts.

This study focused on the evaluation of Quillaja saponin extracts with the additional quality designation DAB-which means the abbreviation of the German Pharmacopoeia (Deutsches Arzneibuch). This label suggests that Quillaja saponin extracts marked in this way are of pharmacopoeial quality and thus stand out from other Quillaja saponin extracts. The DAB ninth edition listed Quillaia saponin as a reagent. According to DAB, its quality must be checked by thin-layer chromatography (TLC), and three closely spaced zones in a defined retention factor (Rf) interval specify the saponin reagent. All the Quillaja saponin extracts obtained from different manufacturers and labeled as DAB quality complied with the TLC test. However, the analysis with high-performance liquid chromatography-quadrupole time-of-flight-mass spectrometry (HPLC-Q-ToF-MS) clearly showed additionally an intense peak pattern of Madhuca saponins in all measured samples. The TLC test for Mahua seed cake, which is the press residue from Madhuca longifolia, surprisingly showed the same three closely spaced zones in the defined Rf interval. The three zones could be identified as Mi-saponins from Madhuca after scraping and extracting them from the stationary phase of the TLC plate and subsequent measurement by HPLC-Q-ToF-MS. Therefore, the specification of the saponin reagent in DAB characterizes erroneously Madhuca saponins that are not listed as a saponin plant source for the saponin reagent.

[Changes in Test Methods for Internationalization in the Japanese Pharmacopoeia (Part 2): Establishment of a Quantitative Method for Lorazepam Using HPLC Analysis].

The Japanese Pharmacopoeia (JP) is an official normative publication that is referred to, for establishing the authenticity and properties and maintaining the quality of pharmaceutics in Japan. Partial amendments are periodically made to these guidelines to keep up with the progress of science and technology, and the international harmonization is revised every 5 years. Thus, "Internationalization of the JP" is one of the more important issues to address for the revision of the JP. For example, the incorporation of the test methods that have been used in other pharmacopeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP), into the JP is a useful approach. In light of this, we have recently reported changes in test methods in the 17th JP, "Establishment of a quantitative test method for clonidine hydrochloride from using a potentiometric titration method to using HPLC". As a part of our ongoing research to change test methods for internationalization, we selected lorazepam. Lorazepam is analyzed using a potentiometric titration method as listed in the 17th JP; however, both the USP and EP use HPLC for quantitative analysis of this drug. In this study, we synthesized the related impurities of lorazepam listed in the USP and the EP and determined their purities using quantitative NMR. The separation conditions of these compounds, including lorazepam, were examined using HPLC and simultaneous analyses were performed. In addition, lorazepam extracted from the tablets was analyzed using conditions similar to those used for the analysis of the related impurities.

Was William Harvey's commitment to experimentation reflected in his clinical practice?

The physician and physiologist Dr William Harvey is known for having discovered that the heart pumps arterial blood round the whole body and receives venous blood from the periphery, which it forwards to the lungs for reoxygenation. Harvey's discovery was based on anatomical and physiological evidence and experiments using ligatures of varying tensions. As a clinician, however, Harvey does not appear to have appreciated the value of experiments in assessing treatment effects. Although he criticised Galenic views about the clinical value of experience and authority in the absence of accompanying empirical evidence, two handwritten prescriptions that he wrote for his friend and future biographer John Aubrey provide evidence that he conformed with Galenic theory when it came to drug therapy in clinical practice. This was consistent with his senior position in the College of Physicians, whose Pharmacopoeia Londinensis was based on Galenic principles, an appreciation of which was required for entry into the College. Harvey's prescriptions reflect this and open a window onto 17th-century therapeutic practice and the personal elements on which such practice was sometimes based.

[Changes in Test Methods for Internationalization in the Japanese Pharmacopoeia (Part 1): Establishment of a Quantitative Test Method for Clonidine Hydrochloride Using HPLC Analysis].

The Japanese Pharmacopoeia (JP) is an official normative guide for maintaining the authenticity of properties and qualities of medicine in Japan. The JP is revised every 5 years, and partial amendments are made from time to time to keep abreast with progress in science and technology and international harmonization. We are conducting a related study on the elimination of toxic reagents from the JP. The elimination of toxic reagents is an important study in relation to the five pillars of the revision of the 18th JP, "Improvement in quality by proactively introducing the latest knowledge and technological advances". In addition, "Internationalization of the JP" is an important issue to be addressed during revision of the JP. Considering international harmonization of the JP, it is important to incorporate the test methods that have been used in other pharmacopoeia, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP) in the JP. To achieve the above, herein, we selected clonidine hydrochloride, which is listed in the 17th JP. A potentiometric titration method is used as a quantitative method for clonidine hydrochloride in the 17th JP; in contrast, a HPLC method is utilized in the USP and the EP. In this study, we synthesized impurities of clonidine hydrochloride and determined their purities using quantitative NMR. In addition, the complete separation conditions of these compounds by HPLC were examined, and simultaneous analysis was performed.

Ensuring public trust in digital therapeutics: a pharmacopeial perspective.

DISCLOSURES: No funding supported the writing of this commentary. The author is employed by US Pharmacopeia. This article was requested by JMCP as a response to the companion Viewpoints article "Decision Makers Need an Approach to Determine Digital Therapeutic Product Quality, Access, and Appropriate Use" by Parcher and Coder (see page 536). Digital Therapeutics Alliance, which is mentioned in this article, is a member of the USP Convention.

Recent updates from the BNF (BNF 81).

The BNF is jointly published by the Royal Pharmaceutical Society and BMJ. BNF is published in print twice a year and interim updates are issued and published monthly in the digital versions. The following summary provides a brief description of some of the key changes that have been made to BNF content since the last print edition (BNF 80) was published.

Medicinal plants from the 14th edition of the Russian Pharmacopoeia, recent updates.

ETHNOPHARMACOLOGICAL RELEVANCE: Herbal medicine in Russia has a long history starting with handwritten herbalist manuscripts from the Middle Ages to the officinal Pharmacopoeia of the 21st century. The "herbophilious" Russian population has accumulated a lot of knowledge about the beneficial effects of local medicinal plants. Yet, for a long time, Russian traditional and officinal herbal medicine was not well known to the international audience. In our previous comprehensive review, we discussed the pharmacological effects of specific plants included in the 11th edition of the Pharmacopoeia of the USSR, which was also for a while used in Russia. The 14th edition of the Russian Federation's State Pharmacopoeia was implemented in 2018. AIM OF THE REVIEW: The aims of the present review are: (i) to trace the evolution of medicinal plant handling from handwritten herbalist manuscripts to Pharmacopoeias; (ii) to describe the modern situation with regulatory documents for herbal medicinal products and their updated classification; (iii) to summarize and discuss the pharmacology, safety, and clinical data for new plants, which are included in the new edition of the Pharmacopoeia. METHODS: New medicinal plants included in the 14th edition of the Russian Federation's State Pharmacopoeia were selected. We carefully searched the scientific literature for data related to traditional use, pharmacological, clinical application, and safety. The information was collected from local libraries in Saint-Petersburg, the online databases E-library.ru, Scopus, Web of Science, and the search engine Google scholar. RESULTS: Investigating the evolution of all medicinal plants referred to in the Russian Pharmacopoeias led us to the identification of ten medicinal plants that were present in all editions of civilian Russian Pharmacopoeias starting from 1778. In the 14th edition of the modern Russian Pharmacopoeia, medicinal plants are described in 107 monographs. Altogether, 25 new monographs were included in the 14th edition, and one monograph was excluded in comparison to the 11th edition. Some of the included plants are not endemic to Russia and do not have a history of traditional use, or on the other hand, are widely used in Western medicine. For 15 plants, we described the specificity of their application in Russian traditional medicine along with the claimed dosages and indications in officinal medicine. The pharmacology, safety, and clinical data are summarized and assessed for nine plants, underlining their therapeutic potential and significance for global phytopharmacotherapy. CONCLUSIONS: In this review, we highlight the therapeutical potential of new plants included in the modern edition of the Russian Pharmacopoeia. We hope that these plants will play an imperative role in drug development and will have a priority for future detailed research.

An investigation of the pharmacological applications used for the Ancient Egyptian systemic model 'ra-ib' compared with modern Traditional Chinese Medicine.

ETHNOPHARMACOLOGICAL RELEVANCE: Ancient Egyptian texts only offer glimpses into their conceptual understandings of the inner-body and illness manifestation. Explanations of how prescribed materia medica were believed to work are rare and obscure, often resulting in modern approximations for ancient terminology such as 'ra-ib'-an ancient Egyptian classification predominantly translated as 'stomach'-leading to misunderstandings of historical texts, and therefore their use of pharmacology. AIM OF THE STUDY: To investigate the ra-ib and the explanatory models of illness from the Egyptian perspective, and to explore the link between these and the prescribed selection of materia medica. To then compare the conceptual mechanics of these treatment strategies with those of another non-Western tradition-namely Traditional Chinese Medicine (TCM)-to provide further insight into potential conceptual frameworks. MATERIALS AND METHODS: We conducted a case study of a unit of Ancient Egyptian texts focusing on the ra-ib. Totalling 34 prescriptions, the first stage lexicographically analysed the texts using cognitive linguistic and translation theories to produce our new understanding. This enabled our comparison of the mechanics of materia medica usage within these texts with those found in TCM outlined by the Pharmacopoeia of the Peoples Republic of Pharmacopeia of the People's Republic of China 2015 for the relevant ingredients. RESULTS: the study demonstrated that-rather than denoting the organ 'stomach'-ra-ib instead constitutes a system running from the mouth, downward to the anus. This is best translated as 'inner thoroughfare', and changes the way in which we attempt to understand potential motivations in the selection of ingredients. By exploring common themes in the use of eleven securely translated ingredients from the Egyptian corpus and the Pharmacopoeia of the People's Republic of China-representing a modern traditional system which understands the body via a series of interconnected systems-we were able to highlight certain themes which might be 'universal' to system-based traditions; this provided new insights into the Egyptian motivations for treatment selection. CONCLUSIONS: Having gained the ancient view of the body and illness, cultural comparisons are important for providing further potential insights and clarifications of a discontinued historical healing tradition. The new understanding of the ra-ib from our study greatly changes the way in which we understand the dynamics of Egyptian ethnopharmacological source material from this period.

Development of a Logic Model for Promoting Incorporation of the Concepts of Impurity-Related ICH Guidelines into Pharmacopoeias Based on Cause and Effect Analysis.

In line with the recent globalization of the drug supply chain and promotion of the use of generic drugs worldwide, quality assurance is required for drugs globally. In particular, controlling impurities is one of the biggest areas of interest regarding pharmaceutical quality, and it is desirable that the latest scientific standards harmonized in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are not only implemented in approval applications but also incorporated in pharmacopoeias which are public standards to ensure pharmaceutical quality more widely. However, incorporation into a pharmacopoeia takes time because careful consideration is required owing to the characteristics of a pharmacopoeia that is widely used for drugs, including those already on the market. To consider a smooth approach for the incorporation, we retrospectively examined approaches to incorporate the concepts of the ICH Q3C, Q3D, and M7 guidelines covering residual solvents, elemental impurities, and mutagenic impurities which are particularly toxic impurities into the European Pharmacopoeia, United States Pharmacopeia-National Formulary, and Japanese Pharmacopoeia, with approaches to implement these guidelines into approval processes in Europe, the U.S., and Japan. We also identified barriers and facilitators to this goal via cause and effect analysis. Moreover, we developed a logic model for the smooth incorporation of the concepts of impurity-related ICH guidelines. We expect that our proposed approach will be applied as a framework to smoothly incorporate the results of international harmonization activities for controlling impurities into each pharmacopoeia.

Demonstrating the influence of HTA: INAHTA member stories of HTA impact.

A central function of health technology assessment (HTA) agencies is the production of HTA reports to support evidence-informed policy and decision making. HTA agencies are interested in understanding the mechanisms of HTA impact, which can be understood as the influence or impact of HTA report findings on decision making at various levels of the health system. The members of the International Network of Agencies for HTA (INAHTA) meet at their annual Congress where impact story sharing is one important activity. This paper summarizes four stories of HTA impact that were finalists for the David Hailey Award for Best Impact Story.The methods to measure impact include: document review; claims analysis and review of reimbursement status; citation analysis; qualitative evaluation of stakeholders' views; and review of media response. HTA agency staff also observed changes in government activities and priorities based on the HTA. Impact assessment can provide information to improve the HTA process, for example, the value of patient and clinician engagement in the HTA process to better define the assessment question and literature reviews in a more holistic and balanced way.HTA reports produced by publicly funded HTA agencies are valued by health systems around the globe as they support decision making regarding the appropriate use, pricing, reimbursement, and disinvestment of health technologies. HTAs can also have a positive impact on information sharing between different levels of government and across stakeholder groups. These stories show how HTA can have a significant impact, irrespective of the health system and health technology being assessed.