• The Korean Journal of Applied Statistics
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• v.24 no.3
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• pp.495-503
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• 2011

When a patent of an innovative (brand-name) small-molecule drug expires, generic copies of the innovative drug may be marketed if their therapeutic equivalence to the innovative drug has been shown. The small-molecule drugs are considered therapeutically equivalent and can be used interchangeably if two drugs are shown to be pharmaceutically equivalent with identical active substance and bioequivalent with comparable pharmacokinetics in a crossover clinical trial. However, the therapeutic equivalence paradigm cannot be applied to biosimilars since the active ingredients of biosimilars are huge molecules with complex and heterogeneous structures, and these molecules are difficult to replicate in every detail. The European Medicine Agency(EMEA) has introduced a regulatory biosimilar pathway which mandates clinical trials to show therapeutic equivalence. In this paper, we discuss statistical considerations in the design and analysis of biosimilar cancer clinical trials.

• Transactions of Materials Processing
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• v.7 no.4
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• pp.382-392
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• 1998

Computer simulations and test trials were carried out to obtain the optimal stamping conditions of the die design of the laser welded automotive body. The stamping process including gravity deflection bead calibration binder wrap, forming and spring back was simulated and compared with the results obtained from test trials. The production variables were determined from a preliminary operation and they were investigated in the simulation and the test trials. The formability was tested under the various conditions, such as the initial position of blank, blank holding force, corner radius and the shape of drawbead. Sound products without fracture, wrinkling and excessive weldline movement were produced by applying results obtained this investigation.

• Journal of Acupuncture Research
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• v.20 no.2
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• pp.18-28
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• 2003

Objective : To research the trends of study related to osteoarthritis with acupuncture in PubMed, and to establish he hereafter direction of acupuncture for osteoarthritis. Methods : We searthed in PubMed, with osteoarthritis and acupuncture limited by abstract, human, English. Results : 1. The pattern of study was as follow: Review article(2), Clinical Trials(13), randomized controlled trials(13). bee venom acupuncture(1), electroacupuncture(1). We further estimated 15 articles. 2. The lesion of osteoarthritis & kinds of acupuncture were as follows: knee(12), hip(2), cervical vertebral(1), bee venom acupuncture(1), electroacupuncture(1). 3. Most clinical trials are related to decrease of pain, functional improvement. 4. 10 of clinical studies provide affirmative result. And they recommend acupuncture for osteoarthritis. 5. 4 of clinical studies provide negative result. And these studies are designed by sham acupuncture method.

• Journal of Acupuncture Research
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• v.24 no.1
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• pp.209-216
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• 2007

Objectives : To review and summarize the existing evidence on acupuncture treatment for cancer and cancer related symptoms. Methods: Literature searches were made through domestic and international databases. Data were extracted according to pre-defined criteria. The methodological quality was assessed using the Modified Jadad scale. Results: Seven studies were included. Two of the studies were high in methodological quality. One study concerning acupuncture treatment for cancerous dyspnea reported insignificant differences between the treatment group and placebo group. The other study concerning auricular acupuncture for cancer related pain showed significant pain relief compared with the control group. All the other studies were non-blinded or uncontrolled trials. Conclusion : The hypothesis that acupuncture may be effective for the treatment of cancer is not supported by the data in recent clinical trials. More accurately designed randomized control trials (RCT) are needed.

• Asian-Australasian Journal of Animal Sciences
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• v.8 no.4
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• pp.311-316
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• 1995

Data on available feed resources, feeding practices and nutrient adequacy of rations under small farm conditions in Sri Lanka were obtained in a baseline survey involving 104 pig farms. The results showed that a wide range of non-conventional feedstuffs are used for pig feeding under typical small farm conditions and that dietary protein quality is a major factor limiting productivity. Following the survey, two on-farm trials were conducted to evaluate cheaper, alternative feeding strategies. In trial 1, a test diet was formulated using several non-conventional feedstuffs and compared with a commercial feed that is normally fed in the farms. In trial 2, the possibility of improving growth rates by amino acid supplementation was evaluated. The results demonstrated that feed costs can be considerably lowered through these packages. Some problems inherent to on-farm livestock trials are highlighted.

• The Korean Journal of Applied Statistics
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• v.25 no.4
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• pp.575-587
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• 2012

The effect of a new treatment is proven through the comparison of a new treatment with placebo; however, the number of parent non-inferiority trials tends to grow proportionally to the number of active controls. In a non-inferiority trial a new treatment is approved by proof that the new treatment is not inferior to an active control; however, both additional assumptions and historical trials are needed to show (through the comparison of the new treatment with the active control in a non-inferiority trial) that the new treatment is more efficacious than a putative placebo. The two different methods of using the historical data: frequentist principle method and meta-analytic method. This paper discusses the statistical methods and different Type I error rates obtained through the different methods employed.

• The Korean Journal of Applied Statistics
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• v.7 no.2
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• pp.35-51
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• 1994

For ethical and economic reasons, clinicla trials must be repeatedly monitored for evidence of treatment benefit or harm. Repeated testing at conventional critical values can substantially inflate the overal type I error rate. To maintain acceptable levels, group sequential procedures have been developed for clinical trials. This article gives a brief overview of the group sequential procedures.

• Journal of the Korean Home Economics Association
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• v.19 no.2
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• pp.1-9
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• 1981

The phenomena of memory have been shown to come out early in life and to develop drastically for early childhood. Therefore, the purpose of this study were examine the development of memory of Korean children and also to see the memory span of Korean children. the subjects in this study were 80 children (male and female each 40 children) from age 3 to age 6. These subjects were devide into two age groups (3~4 age, 5~6 age). the stimulus materials were the numbers and the words. The numbers in this study were chosen from the number problems of WISC. The 42 words which consisted of two phonemes were selected. The number of items was 3 to 9 on the first through the last trial. altogether 14 trials, 7 trials for numbers and 7 trials for words, were given to each subject. Free recall method was sued. The following conclusions could be made. 1. The memory span of Korean early childhood increased as the age of the children increased. 2. The primacy effect was appeared when the age increased. Therefore, rehearsal was appeared as the age of the Korean early childhood increased.

• Communications for Statistical Applications and Methods
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• v.22 no.4
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• pp.389-399
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• 2015

It is important not to overcalculate sample sizes for clinical trials due to economic, ethical, and scientific reasons. Kang and Kim (2014) investigated the accuracy of a well-known sample size calculation formula based on the approximate power for continuous endpoints in equivalence trials, which has been widely used for Development of Biosimilar Products. They concluded that this formula is overly conservative and that sample size should be calculated based on an exact power. This paper extends these results to binary endpoints for three popular metrics: the risk difference, the log of the relative risk, and the log of the odds ratio. We conclude that the sample size formulae based on the approximate power for binary endpoints in equivalence trials are overly conservative. In many cases, sample sizes to achieve 80% power based on approximate powers have 90% exact power. We propose that sample size should be computed numerically based on the exact power.

• The Journal of Korean Obstetrics and Gynecology
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• v.32 no.4
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• pp.87-101
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• 2019

Objectives: The purpose of this study is to investigate the effect of herbal medicine during the Western medicine therapy in adenomyosis. Methods: The author searched 5 electronic databases and search keywords were 'Adenomyosis' and 'Herbal Medicine'. We included randomized controlled clinical trials (RCTs) using herbal medicine therapy combined Western medicine for adenomyosis patients. Results: The author selected 12 studies. The systematic review of the 12 trials indicated that herbal medicine therapy integrated Western medicine therapy was more effective than Western medicine therapy alone. Conclusions: The herbal medicine therapy combined Western medicine for adenomyosis patients seems to improve pain relief and improvement of illness from this research. However, this result should be taken cautiously by unclear risk of bias. More clinical research will be needed to standardize the results of this study through herbal medicine.