• Title/Summary/Keyword: Drug evaluation

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Guideline for Bioequivalence Studies of Controlled Release Products (서방성 제제의 생물학적동등성시험을 위한 가이드라인)

  • Seo, Hyun-Ok;Kim, So-Hee;Ahn, Mee-Ryung;Ahn, Choong-Yul;Park, Hye-Jin;Oh, Eun-Kyung;Lee, Eun-Ju;Kim, Bo-Yeon;Kim, Min-Jeong;Woo, Na-Ry;Seo, Hee-Won;Chung, Soo-Youn
    • Journal of Pharmaceutical Investigation
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    • v.40 no.1
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    • pp.63-66
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    • 2010
  • The "Guidance Document for Bioequivalence Study" was revised for adding to bioequivalence studies of controlled-release products after meal(Korea Food & Drug Administration Notification #2008-22, 2008.5.7). The bioequivalence study design for controlled-release products is $2{\times}2$ crossover under fast and fed condition in respect. For studies of controlled-release products under fed study, the same high-fat diet should be taken within 20 minutes in at least a 10-hour fasting state. The drug products should be administered 30 minutes after the meal started. A high-fat(more than 35 percent of total caloric content of the meal) and high-calorie(over 900 calories) meal is recommended as a test meal for fed BE studies.

Survey and Classification of Pharmaceutical Excipients (국내 의약품 첨가제 정보체계 연구)

  • Park, In-Sook;Park, Sang-Aeh;Kim, Eun-Jung;Park, Hyo-Min;Hong, Chong-Hui;Jnng, Joo-Yeon;Kim, Ho-Jung;Lee, Ji-Hyun;Han, Eui-Sik;Kang, Shin-Jung;Lee, Sun-Hee
    • Journal of Pharmaceutical Investigation
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    • v.36 no.4
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    • pp.239-243
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    • 2006
  • Due to the development of new dosage forms and the improvement or pharmaceutics, the pharmaceutical excipients have become more specified and diverse, and the reclassification on them became necessary. Also with the increasing interests on the kinds and usage amount, related provisions, and evaluation of the pharmaceutical excipients, the systemic and effective control of them was in its demand. Therefore, in this research, we provided the following information on excipients: the type, amount and specification. In order to provide the information, we investigated, analysed and summarized the excipients that are approved by KFDA and published $\ulcorner$Handbook of Pharmaceutical Excipients$\lrcorner$). This handbook is expected to be used as a reference in the development of the pharmaceutics and evaluation in them. As the importance of excipients in pharmaceutics are increasing, IPEC which consist of IPEC-America, IPEC-Europe and JPEC, PDG and ICH have tried to make an international harmonization on excipient. This current status was not an exception to Korea, therefore, the result of this research is expected to make a progress in the evaluation on the excipients to an advanced level.

Culture of rabbit chondrocytes on the HA-agarose scaffold for artificial cartilage

  • Hong, Sung-Ran;Nguyen, Lan-Anh;Kwon, O-Hee;Shin, In-Soo;Kim, Soon-Nam;Man, Choong-Hong;Lee, Ki-Hong;Oh, Ho-Jung;Yoo, Si-Hyung;Kang, Hye-Na;Choi, Seoung-Eun;Lee, Seok-Ho;Hong, Seoung-Hwa;Lee, Young-Moo
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.366.1-366.1
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    • 2002
  • Emerging medical technologies for effective and lasting repair of articular cartilage include delivery of cells or cell-seeded scaffolds to a defective site to initiate de novo tissue regeneration. In this respect. the availability of an appropriate biomaterial scaffold is crucial to allow chondrocyte growth and cartilaginous matrix deposition in a three-dimensional geometry. Hyaluronic acid (HA) molecules are anchored to the chondrocyte membrane via receptors, such as CD44. (omitted)

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Dependence Potential of Tramadol: Behavioral Pharmacology in Rodents

  • Cha, Hye Jin;Song, Min Ji;Lee, Kwang-Wook;Kim, Eun Jung;Kim, Young-Hoon;Lee, Yunje;Seong, Won-Keun;Hong, Sa-Ik;Jang, Choon-Gon;Yoo, Han Sang;Jeong, Ho-Sang
    • Biomolecules & Therapeutics
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    • v.22 no.6
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    • pp.558-562
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    • 2014
  • Tramadol is an opioid analgesic agent that has been the subject of a series of case reports suggesting potential for misuse or abuse. However, it is not a controlled substance and is not generally considered addictive in Korea. In this study, we examined the dependence potential and abuse liability of tramadol as well as its effect on the dopaminergic and serotonergic systems in rodents. In animal behavioral tests, tramadol did not show any positive effects on the experimental animals in climbing, jumping, and head twitch tests. However, in the conditioned place preference and self-administration tests, the experimental animals showed significant positive responses. Taken together, tramadol affected the neurological systems related to abuse liability and has the potential to lead psychological dependence.

A GC analytical method of phthalates in plasticized blood component preparations

  • Chang, Soo-Hyun;Jang, Seung-Jae;Choi, Don-Woong;Kim, Mi-Jeong;Kim, Hee-Sung;Jung, Ki-Sook;Chang, Seung-Yeup
    • Proceedings of the PSK Conference
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    • 2003.04a
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    • pp.276.3-277
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    • 2003
  • A simple, accurate GC analytical technique for the determination of phthalates. commonly used as plasticizers during the manufacturing process of PVC bags, in blood component preparations was developed and validated. The blood component preparations were extracted with n-hexane. The n-hexane layer was evaporated to dryness and the residue was dissolved in 1 $m\ell$ of n-hexane and analyzed by GC and GC/MS. (omitted)

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EFFICACY EVALUATION OF THE WHITENING COSMETICS USING MELANOGENESIS INHIBITION ASSAY COSMETICS IN B-16 MELANOMA CELL

  • S. J. Yang;S. J. Jang;Park, S. S.;J. Y. Jang;K. H. Son;Lee, J. P.;Lee, K. S.;M. Y. Heo;Kim, Y. O.
    • Proceedings of the SCSK Conference
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    • 2003.09b
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    • pp.544-544
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    • 2003
  • We investigated the inhibitory effect of whitening materials with growth factor or alone on melanomas derived from Human (B-16) and mouse (SK-MEL-31) using melanin content. Melanin content was determined by the absorbance value at 470nm per cells. we used the growth factors known as activators of Adenylate cyclase, Protein kinase C and tyrosine kinase pathway separately. In addition, we compared the action of UV-induced with non-biological growth factor with whitening materials in melanomas derived from Human and mouse. The results showed that the aspect of inhibitory effect of whitening materials on B16 and SK-MEL-31 was not different. And, the action of each growth factor involved in the differentiation and proliferation of melanoma on the inhibition of melanogenesis in B-16 and SK-MEL-31 using whitening agents showed no difference. Also, The action of UV -induced and non-biological growth factors didn't exhibit different pattern on the effect of whitening agent in B-16 and SK-MEL-31.

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