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Thus, a negative result in this ROS assay would indicate a very low probability of phototoxicity, whereas a positive result would be a flag for follow-up assessment. Upon international harmonization activities supported by several agencies and industrial groups, ROS assay was successfully adopted as International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) S10 guideline (2014) and Organisation for Economic Co-operation and Development (OECD) test guideline 495 (2019).The role of pharmaceutical education in primary health care for self-medication needs recognition. Hence, we conducted a survey on quality assurance of foods/pharmaceuticals at 75 pharmaceutical schools in Japan, as part of a project for the Subcommittee of Clinical Pharmacy and Pharmaceutical Sciences, Science Council of Japan. The set of questions in the survey focused on two subjects, one set was related to the lectures on "foods with health claims" (I) and the other set was on quality assessment of pharmaceuticals (II). For each subject, we asked whether there were lectures on these subjects and whether all items were covered. We also asked for the title of lectures, major field of experts in charge, and class standing. We received a response from 60 schools. Thirty-two schools had lectures on subject I in which all seven items were covered. GSK8612 However, "regulatory sciences", "borderline of pharmaceuticals to non-pharmaceuticals", and "quality assurance of foods" were not explained in 22, 12, and 15 schools, respectively. Twenty-six schools had lectures on subject II in which all six items were covered. However, "definition of quality", "quality assurance", "classification of pharmaceuticals", and "Chemistry, Manufacturing and Control" were not explained in 12, 11, 12, and 29 schools, respectively. The high rate of insufficient explanation for some of the items in subject I and II may be due to the lack of description about them in the "Model Core Curriculum for Pharmacy Education". We conclude that including these items in the curriculum can have important implications for pharmaceutical education.The author believes that the three pillars of pharmaceutical sciences (PS) in Japan are drug development science, medical pharmacy, and quality management science. Of these, the most PS-like science is quality management science, both historically and presently. Considering the balance of safety and efficacy is the basis of PS. The definition of "quality" is the degree to which a set of inherent properties of a product, system, or process fulfills requirements in Q9 of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). In our society, pharmaceutical science graduates including pharmacists, are active participants, not only in the pharmaceutical industry, including a pharmacy, but also in the food industry, especially for quality assurance and quality control. This report presents a focused overview of quality in health foods, foods with health claims, and pharmaceutical products and discusses the importance of a curriculum focusing on quality assurance, control, and management in pharmaceutical education.General views on three aspects were discussed. The first aspect is regulatory categories, which can range from "soft to hard", an expression using the English and Japanese translation of the French term, "drogue douce" (soft drug). This categorization starts with "so-called health foods" and extends to Foods with Health Claims [Foods with Nutrient Functional Claims (FNFC); Foods with Functional Claims (FFC); Foods for Specified Health Uses (FOSHU)], OTC drugs, and ethical drugs. "The Basic Policy for New Drug Approval" (1967) made a distinction between OTC and prescription drugs. FOSHU (1991) originally included foods for "patients", such as low allergen rice with preventive "health claims". Foods for Medical Uses (FMU) later became an independent subcategory under Foods for Special Dietary Uses. On the other hand, manufacturers of FFC can make various "health claims" on the basis of randomized controlled trial or systematic review (2015). Products in the intermediate zone between food and drug have an annual market of over 2 trillion yen (US$ 20 billion). The second aspect is the five elements, i.e., quality, safety, efficacy, information, and cost, which are derived from WHO's "The rational use of drugs" (1985). The adoption of Sustainable Development Goals (SDGs) by the UN General Assembly (2015) led to the addition of "ecology" as the sixth element, which is applicable for herbal and animal raw materials. The third aspect is quality control and quality assurance. This initially began with manufactured products and was expanded to the service fields handled by various health workers including pharmacists.IgA nephropathy is one of the leading causes of chronic kidney disease in Japan. Since the origin and mechanisms by which IgA nephropathy develops currently remain unclear, a confirmed disease diagnosis is currently only possible by highly invasive renal biopsy. With the background of the salivary microbiome as a rich source of biomarkers for systemic diseases, we herein primarily aimed to investigate the salivary microbiome as a tool for the non-invasive diagnosis of IgA nephropathy. In a comparison of salivary microbiome profiles using 16S rRNA amplicon sequencing, significant differences were observed in microbial diversity and richness between IgA nephropathy patients and healthy controls. Furthermore, recent studies reported that patients with IgA nephropathy are more likely to develop inflammatory bowel diseases and that chronic inflammation of the tonsils triggered the recurrence of IgA nephropathy. Therefore, we compared the salivary microbiome of IgA nephropathy patients with chronic tonsillitis and ulcerative colitis patients. By combining the genera selected by the random forest algorithm, we were able to distinguish IgA nephropathy from healthy controls with an area under the curve (AUC) of 0.90, from the ulcerative colitis group with AUC of 0.88, and from the chronic tonsillitis group with AUC of 0.70. Additionally, the genus Neisseria was common among the selected genera that facilitated the separation of the IgA nephropathy group from healthy controls and the chronic tonsillitis group. The present results indicate the potential of the salivary microbiome as a biomarker for the non-invasive diagnosis of IgA nephropathy.
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