• Journal of Evidence-Based Herbal Medicine
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• v.3 no.1
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• pp.19-23
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• 2010

Gyeongsangbukdo is nation's leading producer of medicinal crop. Based on this, Gyeongbuk-specific measures for the development of oriental medicine industry is proposed. The aim is the development of oriental medicine industry and regional economic in Gyeongbuk. Production, research and development, manufacturing, distribution are constructed in industrial cluster. And each step need a quality control strictly. In production field, make the seed valley of medicinal crop and Good Agricultural Practice park. In research and development field, study on efficacy of oriental medicine with Good Laboratory Practice. In manufacturing field, make industrial park for foods, dietary supplements and drugs with Good Manufacturing Practice. In distribution field, supports advanced distribution program with Good Supply Practice.

• Toxicological Research
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• v.1 no.1
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• pp.31-41
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• 1985

The Japanese Good Laboratory Practice (GLP) Standard on Drugs was finalized as a guideline and implemented in April, 1983. This standard is intended to ensure the quality and integrity of the data from nonclinical toxicity studies submitted to the Ministry of Health and Welfare in support of applications for approval to manufacture or import new drugs or to be used in the reevaluation of previously approved drugs. The standard includes a guideline for organizational matters, personnel, facility, equipment, testing operation, documentation and conduct of studies. Principles and influences of implementation of Japanese GLP will be discussed briefly in comparison with foreign GLPs.

• Journal of Evidence-Based Herbal Medicine
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• v.1 no.1
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• pp.29-34
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• 2008

Good Laboratory Practice(GLP) is becoming more and more important in the research and development of Oriental Pharmacy(OP) and its globalization. If a OP product is to be registered as Over-the-Counter(OTC) drug and enter international markets, the safety and efficacy studies conducted according to GLP requirements is necessary. The article introduces the content of GLP requirements and the recent development of GLP. The safety and efficacy assessment for OP or herbal medicines under GLP are also covered. This paper also briefly describes the areas that should be covered by GLP regulation and the areas that do not need to follow GLP requirements.

• Journal of Korean Society of Archives and Records Management
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• v.11 no.1
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• pp.183-206
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• 2011

The research and laboratory records management is the prerequisite for quality research. Quality research assurance system can work out on the sound basis of quality research records management. It is an important task that establishing a proper research and laboratory records system for obtaining quality of research according to the rapid growth of Research and Development area in Korea and the trend of electronic laboratory notebooks. The purpose of this study is to identify issues and find a direction for solutions related to the research and laboratory records management systems. For this after analysing previous studies and current status related to the research records management and GLP(Good Laboratory Practice) is benchmarked as a best practice for quality research, some suggestions for enhancement of research records management are given as a result.

• Toxicological Research
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• v.25 no.1
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• pp.1-8
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• 2009

Validation specifies and coordinates all relevant activities to ensure compliance with good laboratory practices (GLP) according to suitable international standards. This includes validation activities of past, present and future for the best possible actions to ensure the integrity of non-clinical laboratory data. Recently, validation has become increasingly important, not only in good manufacturing practice (GMP) institutions but also in GLP facilities. In accordance with the guideline for GLP regulations, all equipments used to generate, measure, or assess data should undergo validation to ensure that this equipment is of appropriate design and capacity and that it will consistently function as intended. Therefore, the implantation of validation processes is considered to be an essential step in a global institution. This review describes the procedures and documentations required for validation of GLP. It introduces basic elements such as the validation master plan, risk assessment, gap analysis, design qualification, installation qualification, operational qualification, performance qualification, calibration, traceability, and revalidation.

• Toxicological Research
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• v.1 no.1
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• pp.43-48
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• 1985

• Toxicological Research
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• v.22 no.2
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• pp.109-116
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• 2006

Safety pharmacology studies are conducted to investigated the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above. In the International Conference on Harmonisation (ICH), the guideline 'S7A: Safety Pharmacology Studies for Human Pharmaceuticals' has been developed and reached Step 5 of the ICH process in 2001. Now the Korea Food and Drug Administration (KFDA) are going to transfer 'The Guideline for General Pharmacology' into 'The Guideline for Safety Pharmacology'. Safety pharmacology studies should be performed in compliance with Good Laboratory Practice (GLP). Thus, the present paper reviews the Japanese GLP guidelines for pharmaceuticals to help the conduct and inspection of safety pharmacology studies in compliance with GLP. We also reviewed the ICH guidelines 'S7B revised : The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals' and 'E14 : The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs' to apply our drug approval systems.

• Journal of the Korean Applied Science and Technology
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• v.41 no.2
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• pp.172-187
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• 2024

In good laboratory practice (GLP), analytical method validation prior to toxicity testing is important in terms of concentration setting and sample preparation. The testing agency performed validation of the two requested test substances using high-performance liquid chromatography (HPLC), and as a result, the analysis satisfied the criteria for specificity, system suitability, linearity, intra-day reproducibility, homogeneity, stability, concentration analysis, and quality control. The method was established and validated. However, the content of standard substances in the test report of the requesting institution was found to be 1.34 and 1.17 times higher than the results of the testing institution, confirming that deriving results through validation of analysis methods suitable for GLP is important in terms of securing reliability and stability.

• Journal of Technologic Dentistry
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• v.10 no.1
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• pp.171-175
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• 1988

A good material selection and high dental techniques shall be required in all procedure from waxing up to investing of wax patten in order to get a cast restoration with good adaptability. Generally, wax and investing material should not have any deformation property but they art not so perfact in practice. Therefore, as the one of methods to produce more perfact, less deformation property and excellent product, it is necessary to eliminate the problems which can cause a deformation in each procedure.

• The Journal of Korean Medicine
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• v.35 no.2
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• pp.28-33
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• 2014

Background: Samul-tang (Si-Wu-Tang, SMT) is a traditional herbal formula, which has been widely used to treat various diseases such as menstrual irregularity, bleeding and leucorrhea. Although many studies have investigated the pharmacological properties of SMT, its toxicity information has not yet been fully elucidated. Methods: Five Sprague Dawley (SD) rats of each sex were given a single dose (5000 mg/kg) of SMT by gavage; control rats received the vehicle only. After the single administration, mortality, clinical signs, body weight changes and gross findings were monitored for 15 days in accordance with Good Laboratory Practice (GLP) principles. Results: In a single oral dose toxicity study, there was no adverse effect on mortality, clinical sign, body weight change or gross finding in any treatment group. Conclusions: The results indicate that SMT did not induce toxic effects at a dose level up to 5000 mg/kg in rats and its median lethal dose ($LD_{50}$) was considered to be over 5000 mg/kg/day body weight for both genders.