• Title/Summary/Keyword: Trials

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Safety, High Quality, Confidence of Kaneka CoQ10

  • Fujii, Kenji
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 2006.11a
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    • pp.139-145
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    • 2006
  • Kaneka Corporation (Kaneka) has been manufacturing CoQ10 under GMP regulation since 1977. Kaneka has a sophisticated quality control system and has been supplying high quality CoQ10 materials to the worldwide customers (Kaneka CoQ10) for about 30 years. Kaneka CoQ10 is characterized by a lot of safety data, which are derived from clinical trials with healthy volunteers (single-dose and 4-week multi-dose safety studies), animal studies (13-week sub-chronic study in dogs and 52-week chronic study in rats), three types of mutagenicity test, six type of skin irritation test (for cosmetics), and others. The risk assessment of CoQ10 was performed by Council for Responsible Nutrition (USA). They reviewed many of available clinical data including clinical trials using Kaneka Q10, and concluded that the upper level for supplements (ULS) of CoQ10 is 1,200 mg/day (Hathcock and Shao. 2006, Regulatory Toxicology and Pharmacology, 45, 282 - 288).

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Maximum Tolerated Dose Estimation by Stopping Rule and SM3 Design in a Phase I Clinical Trial (제 1상 임상시험에서 멈춤 규칙과 SM3 디자인을 이용한 최대허용용량 추정법)

  • Kim, Byoungchan;Kim, Dongjae
    • The Korean Journal of Applied Statistics
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    • v.27 no.1
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    • pp.13-20
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    • 2014
  • Phase I Clinical Trials estimate a Maximum Tolerated Dose(MTD). In this paper, an MTD estimation method applied stopping rule is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the Continual Reassessment Method(CRM) method using a Monte Carlo simulation study.

Liposome-Mediated Cancer Gene Therapy: Clinical Trials and their Lessons to Stem Cell Therapy

  • Lee, Jung-Hoon;Lee, Min-Jae
    • Bulletin of the Korean Chemical Society
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    • v.33 no.2
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    • pp.433-442
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    • 2012
  • The promise of stem cell therapy for various clinical applications seems getting realistic. An increasing number of researchers, from virtually every discipline of natural sciences, are flocking into this new world. Only ten years ago, gene therapy was the medicine for the 21st century. The possibility was endless. Although the science itself underlying gene therapy was very young, the field was exploding under the optimism that this new medicine would revolutionize both the basic and clinical sciences. For many reasons, the initial target was cancer. Here, we will focus on the results of cancer gene therapy clinical trials using liposome or nonviral gene carrier, hoping that the lesson from here will be a guideline for the new generation of cell-based therapies.

Pros and Cons of Various Research Designs in Clinical Psychiatry (정신과 연구에서 다양한 임상연구방법의 장단점)

  • Ha, Ra Yeon;Cho, Hyun-Sang
    • Korean Journal of Biological Psychiatry
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    • v.19 no.4
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    • pp.159-163
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    • 2012
  • An appropriate research design for hypotheses and purposes leads to a good quality of research results. In this review article, we summarized the types of research methods and described the characteristics of clinical trials. Research designs are categorized into observational studies and experimental ones, depending on data collecting methods. In an observational study, there are cross-sectional, cohort and case-control studies. Parallel groups design and crossover trial studies are representative designs in a randomized controlled trial study, a kind of experimental study. Clinical researchers should understand the characteristics of clinical research designs including advantages and disadvantages and choose the suitable design according to their study purposes and the nature of collected data or subjects.

The Effect of Uncertainty in Sea Trial Measurement System on Speed-Power Performance

  • Seo, Dae-Won;Noh, Jackyou
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.26 no.3
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    • pp.269-276
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    • 2020
  • Sea trial tests are necessary to verify speed-power performance, and are an import contract between ship owners and shipyards. The International Organization for Standardization (ISO) published ISO 15016:2015, which specifies the correlation method between model and full-scale ships. The results of sea trials have been questioned because of the uncertainty of speed and power measurements, especially when sea conditions differ from ideal calm water conditions. In this paper, such uncertainties were investigated by utilizing the standard speed-power trial analysis procedure defined in ISO 15016:2015 through Monte Carlo simulations. It was found that the expanded uncertainty of the delivered power (PDid) at 95 % confidence interval (k = 2) was ±1.5 % under 75 % MCR conditions.

Response Evaluation of Chemotherapy for Lung Cancer

  • Hwang, Ki-Eun;Kim, Hak-Ryul
    • Tuberculosis and Respiratory Diseases
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    • v.80 no.2
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    • pp.136-142
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    • 2017
  • Assessing response to therapy allows for prospective end point evaluation in clinical trials and serves as a guide to clinicians for making decisions. Recent prospective and randomized trials suggest the development of imaging techniques and introduction of new anti-cancer drugs. However, the revision of methods, or proposal of new methods to evaluate chemotherapeutic response, is not enough. This paper discusses the characteristics of the Response Evaluation Criteria In Solid Tumor (RECIST) version 1.1 suggested in 2009 and used widely by experts. It also contains information about possible dilemmas arising from the application of response assessment by the latest version of the response evaluation method, or recently introduced chemotherapeutic agents. Further data reveals the problems and limitations caused by applying the existing RECIST criteria to anti-cancer immune therapy, and the application of a new technique, immune related response criteria, for the response assessment of immune therapy. Lastly, the paper includes a newly developing response evaluation method and suggests its developmental direction.