Orthomedico Inc.
| Booth No. | 2-303 |
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We support FFC system-related scientific evidence acquisition and notification submission, as well as online market research.
Our professional group of PhD, Pharmacists, Clinical laboratory technicians, Nutritionists, and Biostatisticians support product data acquisition and publication! We can provide support from market research, exploration of food functions using genome analysis technology, planning and implementation of human studies, notification of functional food products, and planning sales promotion opportunities for your products.
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| Product / Service |
Clinical trial conduction upon request Clinical trial design for evidence-based food safety assessment Support for dossier notification as Foods with Function Claims Market research service using health and medical data Exploring food functions using genome analysis technology |
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| URL | https://www.orthomedico.tokyo/ |
Presentaion
| Date | 10月23日 12:00～12:20 | Location | PI |
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| Title | Support for Obtaining a "Rational Basis" for Products with Functianal Features | ||
| Detail | For a product to be labeled as having a particular "performance" or "effect", there must be a rational basis to support the claim. Such rationales include (1) results from tests and surveys, or (2) opinions of specialists, professional associations and institutes, as well as academic literature. In this presentation, we will introduce the methodology of testing, surveying and academic writing to obtain a "rational basis". | ||
| Date | 10月23日 13:00～13:20 | Location | PI |
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| Title | Approaches to Safety Evaluation of Novel Foods in Overseas | ||
| Detail | Major overseas countries have established systems for granting health claims to food products, and it is necessary to understand the food regulations of each country when developing products for the global market. In this presentation, we will focus on the safety evaluation approach in particular in the procedures for health claim substantiation in the US, EU, China, and ASEAN, etc. | ||
| Date | 10月23日 15:00～15:20 | Location | PI |
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| Title | Rationale for Target Sample Size for Safety Assessment in Clinical Trials | ||
| Detail | It is essential to design a clinical trial for safety assessment with an appropriate number of participants. However, the guidelines for "Foods for Specified Health Use" and "Food with Functional Claims" vaguely describe the study design for safety assessment, making it difficult to understand what kind of study should be conducted. In this presentation, we will propose a rationale for the number of participants and the method for its calculation. | ||
| Date | 10月23日 15:30～15:50 | Location | PI |
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| Title | Diversity of Safety Assessment in Clinical Trials | ||
| Detail | Although there are guidelines for the items and duration of safety asseement in clinical trials of food products, the number of participants to be studied is not clearly prescribed. In this presentation, we will introduce various definitions in food safety and the scale of clinical trials required for such evaluation. | ||
| Date | 10月24日 12:00～12:20 | Location | PI |
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| Title | Trend of Global Functional Food Research from the Aspect of Trial Registration | ||
| Detail | In the study of functional foods, depending on the results of safety and efficacy studies, the course of research and development can be impacted in many ways, in which the results are reflected in product labelling and health claims. In this presentation, we will analyze and review the Japanese trial registry, UMIN-CTR, and the international version, ClinicalTrials.gov, to predict future trends and areas of potential growth. | ||
| Date | 10月24日 13:30～13:50 | Location | PI |
|---|---|---|---|
| Title | Diversity of Safety Assessment in Clinical Trials | ||
| Detail | Although there are guidelines for the items and duration of safety asseement in clinical trials of food products, the number of participants to be studied is not clearly prescribed. In this presentation, we will introduce various definitions in food safety and the scale of clinical trials required for such evaluation. | ||
| Date | 10月24日 15:30～15:50 | Location | PI |
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| Title | Bias Risk Assessment in Systematic Reviews | ||
| Detail | A systematic review (SR) is a method of scientific evidence evaluation using multiple relevant references and can be considered as one of the best forms of evidence. However, the quality of SR as an evidence depends on the high risk of bias in the clinical trials being evaluated. In this presentation, we will introduce the factors that can increase the risk of bias in SR. | ||
| Date | 10月24日 16:00～16:20 | Location | PI |
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| Title | Proposal for Clinical Trials Based on Meta-analysis | ||
| Detail | Once a food clinical trial confirms a significant difference in the primary outcome, it is rarely followed by another similar confirmatory trial. This leaves many trials with insufficient statistical power. Retesting can improve statistical power, whereas meta-analyses can strengthen the evidence. In this presentation, we will focus on the possible methods to achieve these objectives. | ||
| Date | 10月25日 14:00～14:50 | Location | PI |
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| Title | Safety Assessment of Novel Food Ingredients Using Gene Expression Analysis Technologies | ||
| Detail | As research on the relationship between gene expression and repression mechanisms and life phenomena progresses, various genes responsible for different life phenomena have been identified. It is a well-known fact that food components and nutrients affect gene expression, and many reports have studied such relationship. In this presentation, we will explain how gene expression analysis technology is used for the safety assessment of novel food ingredients. | ||
| Date | 10月25日 15:00～15:50 | Location | PI |
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| Title | Insight concerning Safety and Efficacy Evaluation for Food with Functional Claims | ||
| Detail | A regular diet is important for maintaining good health, and the use of health foods is also an option to achieve so. While a variety of health foods are being marketed, it is essential that high-quality clinical trials are always conducted to evaluate the safety and health functions of those foods. In this presentation, we will introduce the methods to evaluate the safety and health function of food products. | ||