• Proceedings of the PSK Conference
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• 2000.10a
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• pp.206.2-206.2
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• 2000

• Proceedings of the PSK Conference
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• 2003.10a
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• pp.22-24
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• 2003

This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)

• Proceedings of the Korean Society of Applied Pharmacology
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• 2002.07a
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• pp.198-198
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• 2002

• The Korean Journal of Applied Statistics
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• v.15 no.2
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• pp.281-296
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• 2002

On the new medical system separating the prescription and dispensing of the drug, the qualification of pharmacist in substitution of prescribed medicine was restricted, except bioequivalence-certified drugs. Also, Korean Food and Drug Association(KFDA) revised the bioequivalence regulation on August, 2001 Among many changes from old guideline, impressive one is the statistical consideration. Specially, to estimate and analyze bioequivalence measures, AUC and $C_{max}$, the log-transformed model is recommended and the equivalence interval is modified from $\pm$20 rule to [In(0.8),In(1.25)] one. This meaningful act is very hope-for because it is statistically reasonable and is agreed with worldwide bioequivalence guideline, including USA, EU, Japan and Canada. In this paper, we introduce the new regulation of assessing bioequivalence, announced at August, 2001, mainly on statistical view points. Key points for the new regulation are discussed and the minimum sample size based on simulation studies are proposed.

• Proceedings of the Korean Society of Applied Pharmacology
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• 2007.11a
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• pp.117-126
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• 2007

Cosmetics have mild activity on the human body, and intended to be used for cleaning, beautifying the human body, and also keeping healthy skin or hair, promoting attractiveness or altering the appearance. Functional cosmetics, in other words cosmeceuticals, are restricted for following functions: 1) Whiten the skin tone by preventing deposition of melanin pigmentation or lightening of the color of melanin of skin, 2) alleviate or improve wrinkles of the skin, and 3) protect the skin from the ultra violet rays from the sun. According to the functions of the functional cosmetics, skin whitening products, anti-wrinkle products, and suntan & sunscreen products are manufactured. In order to manufacture and import the functional cosmetics in Korea, the approval process in KFDA is necessary. The review process in KFDA is performed based on The Korea Food and Drug Administration Notification 2007-44, "The Regulation of Reviewing the Functional Cosmetics" (June 29, 2007). Only after the approval of KFDA, functional cosmetics are allowed to advertise to the consumers for their functionality.

• Environmental Mutagens and Carcinogens
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• v.26 no.2
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• pp.53-58
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• 2006

Normally, environmental toxicants are classified as endocrine disruptors if they interfere with regulation of cellular function by endogeneous steroids through inhibition of receptor binding and/or transcriptional activation. So, many studies have been performed about agonist/antagonist of hormone receptor to study mechanisms of endocrine disruptors. If toxicants affect steroid biosynthesis and/or degradation and alter hormone homeostasis, these also are classified as endocrine disruptors. But there are not many studies of the mechanisms of endocrine disruptors on the basis of alteration of steroid biosynthesis and/or degradation. Isolation and culture of Leydig cells from testis is one of methods for the steroidogenesis screening assays to evaluate a substance for altering steroidogenesis. Leydig cells were harvested using the method described by Klinefelter with modifications. Leydig cells were purified by perfusion of testis and incubation ($34^{\circ}C$, 80cycles/minute, 20 minutes) with collagenase (0.25 mg/kg), centrifugal elutriation, percoll gradient centrifugation and BSA multidensity gradient centrifugation. To confirm if this method is one of appropriate tools to evaluate a substance for altering steroidogenesis, ketoconazole, positive control was administered to purified Leydig cells. Ketoconazole ($10^{-8}M$ and above) significantly reduced testosterone production in purified Leydig cells. From above results, we suggest that this method for steroidogenesis screening assay appears to be a appropriate tool to detect suspected compounds for altering steroidogenesis.

• Toxicological Research
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• v.17
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• pp.185-188
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• 2001

Genetically modified foods and food additives are derived from organisms that have been inserted foreign genetic materials by recombinant DNA techniques to improve the quality or any other pur-poses. The problems such as toxicity, allergenicity and antibiotics resistance in the safety of genetically modified foods are usually concerned. In Korea, the safety of foods is ensured by the Food Sanitation Act. Although there is no specific provision regarding the genetically modified foods in it, any foods that might cause negative effect(s) on public health or human life are prohibited to sell in the market. In order to systematically evaluate safety of genetically modified foods, the Korea Food and Drug Administration (KFDA) promulgated "Guidelines regarding review of safety assessment data for genetically modified foods and food additives (KFDA Notification 1999-46)". The objectives of these guidelines are to ensure safety of genetically modified foods and food additives. In order to evaluate the safety of genetically modified foods. KFDA operates a special expert committee composed by experts from government, universities, research institutes. and consumer's unions. Recently. manufacturers and consumers are interested in the issues on safety and labeling of genetically modified foods, because of increment of imported genetically modified crops and processed foods. Since government and consumers unions have different viewpoints, their positions regarding the issue are different each other. Therefore, the regulation of labeling on genetically modified foods is prepared and should be enforced at July 2000 in Korea. in Korea.

• The Korean Journal of Nuclear Medicine
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• v.38 no.2
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• pp.140-142
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• 2004

As a molecular imaging is the most up-to-date technology in Nuclear Medicine, it has complicate ethical and regulatory problems. For animal experiment, we have to follow institutional animal care committee. for clinical experiment, we have to get approval of Institutional Review Board according to Helsinki declaration. In addition, approval from Korea Food and Drug Administration (KFDA) is essential for manufacturing and commercialization. However, too much regulation would suppress development of new technology, which would result in the loss of national competitive power. In addition, most new radioactive ligands for molecular imaging are administered to human at sub-pharmacological and sub-toxicological level. In conclusion, a balanced regulation is essential for the safety of clinical application and development of new technology.

• Journal of Biomedical Engineering Research
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• v.31 no.2
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• pp.129-133
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• 2010

Intense pulsed light(IPL) is a photo-therapeutic medical device using xenon lamps with optical characteristics of incoherence, defocusing, and polychromatic. IPL has been recognized as a representative medical therapeutic device with growth of domestic skin care market. However, there is no standard regulation manual and guideline to evaluate the safety and performance of IPL. International Electrotechnical Commission(IEC) is being statued "Technical Report IEC TR 60825-16" which is a guidelines for the safe use of intense light source equipment on humans and animals. In this study, a standard Korea Food & Drug Administration (KFDA) regulation for the safety and performance of IPL was suggested by developing minimal evaluation methods for optical parameters of IPL such as output energy density, pulse mode, spot size, wavelength and uniformity of output light. We expect that this study may be a step to statue a standard regulation manual and guideline for IPLs used in domestic.

• Journal of Pharmacopuncture
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• v.11 no.3
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• pp.93-97
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• 2008

Objective: This study was done to investigate the safety of Fel Ursi pharmacopuncture solution manufactured with freezing dryness method to use eye drop. Methods: The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Fel Ursi pharmacopuncture solution was medicated in the left eye of the rabbits, the author observed eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Results: 1. After Fel Ursi pharmacopuncture solution was medicated in the left eye of the rabbits, there wasn't physical problem at 9 rabbits. 2. After Fel Ursi pharmacopuncture solution was medicated in the left eye of the rabbits, there wasn't eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Conclusions: I suggested that Fel Ursi pharmacopuncture solution didn't induced eye irritation in rabbits.