• Title/Summary/Keyword: Application forms

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Application of SUPAC-MR in Processing Postapproval Changes to Modified Release Sold Oral Dosage Forms (경구용 서방성/지연성 성형제품의 허가 후 변경사항 관리를 위한 SUPAC-MR 응용)

  • Sah, Hong-Kee;Cho, Mi-Hyun;Park, Sang-Ae;Yun, Mi-Ok;Kang, Shin-Jung
    • Journal of Pharmaceutical Investigation
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    • v.34 no.3
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    • pp.229-254
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    • 2004
  • The objective of this study was to scrutinize the rationale of SUPAC-MR and its application in processing postapproval changes to modified release solid oral dosage forms. The types of postapproval changes that were primarily covered with SUPAC-MR included variations in the components and composition, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. SUPAC-MR defined levels of postapproval changes that the industry might make. Classification of such categories was based on the likelihood of risk occurrence and potential impact of changes upon the safety and efficacy of approved drug products. In most cases, the changes could be classified into 3 levels. It described what chemistry, manufacturing, and control tests should be conducted for each change level. The important tests specified in SUPAC-MR were batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. It then suggested what type of a filing report should be submitted to the FDA for each change level. In general, level 1 changes could be reported in an annual report, whereas level 2 and/or 3 changes could be submitted in changes-being-effected or prior approval supplements. It could be understood that the purpose of SUPAC-MR was to maintain the safety and quality of approved modified release solid oral dosage forms undergoing certain changes. At the same time, it contributed to providing a less burdensome regulatory process with the manufacturers when they wanted to make postapproval changes. European regulatory agencies also implemented SUPAC-like regulations in handling such changes to drug products. Therefore, in this study a recommendation was made for KFDA and the Korean industry to evaluate thoroughly the usefulness of these guidances and regulations in dealing with postapproval changes to modified release solid oral dosage forms.

Reconstruction on Application Category of Pharmaceutical Additives and Boundaries of Pharmaceutical Additives according to the Dosage Forms (첨가제의 배합목적 재정비와 제형에 따른 첨가제의 범위)

  • Cho, Cheong-Weon;Kim, Seung-Soo;Cho, Won-Kyung;Park, Hyo-Min;Park, In-Sook;Jung, Joo-Yeon;Chung, Sang-J.;Lee, Sun-Hee;Hwang, Sung-Joo
    • Journal of Pharmaceutical Investigation
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    • v.37 no.6
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    • pp.403-411
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    • 2007
  • The importance of pharmaceutical additives is increasing and the sorts and application categories are being classified in detail. International pharmaceutical council based on IPEC-America, IPEC-Europe and JPEC was established for specifications, safety and efficacy, approval regulations of pharmaceutical additives in 1992. Therefore, scrutinized examination of pharmaceutical additives used for already approved domestic drug was performed under the supervision of KFDA and nomenclature on application categories of pharmaceutical additives was summarized and endowed their glossary. Additionally, the boundaries of pharmaceutical additives according to the dosage forms based on the principle of the dosage forms of Korean pharmacopoeia were classified. These informations could be available for standards & experimental methods, approval, evaluation, audit of drug and contribution for national welfare.

Development of the Nursing Record Forms for Effective Home Care Nursing -Focused on Postpartum Women following a Cesarean Section and Newborns- (가정간호업무 효율성을 위한 간호활동 기록도구 개발 -제왕절개 산욕부와 신생아를 중심으로-)

  • HwangBo, Su-Ja;Yang, Jin-Hyang
    • Journal of Korean Academic Society of Home Health Care Nursing
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    • v.10 no.2
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    • pp.103-112
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    • 2003
  • Purpose: The purpose of this study was to develope nursing activities record to improve home care nursing for postpartum women following a Cesarean section and newborns. Method: This study for instrument development had three phases: first, selection of nursing activities according to intervention, second, validation of the preliminary home care nursing activities, and third. application of the home care nursing activities. The subjects for validaton were 137 home care nurses and clinical nurses in department of maternity. Result: By Fehring's method, 116 nursing activities according to 19 interventions were included in the preliminary nursing activities record. Among them, 51 critical nursing activities and 65 supporting nursing activities were chosen. During the final process of validation, 121 nursing activities were included. Conclusion: In order to have systemic standardization of this record forms, replication and application in the various home nursing area is need in the future.

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Potentiometric Back Titration of Isoniazid in Pharmaceutical Dosage Forms Using Copper Based Mercury Film Electrode (구리수은막 전극에을 사용한 이소니아자이드의 전위차 역적정)

  • Gajendiran, M.;Nazer, M.M. Abdul Kamal
    • Journal of the Korean Chemical Society
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    • v.55 no.4
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    • pp.620-625
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    • 2011
  • A simple, rapid potentiometric back titration of Isoniazid (INH) in the presence of Rifampicin (RIF) in tablets and syrups is described. The method is based on the oxidation of INH by a known excess of copper (II) ion and the back titration of unreacted copper (II) ion potentiometrically with ascorbic acid using a lab-made Copper Based Mercury Film Electrode (CBMFE). The titration conditions have been optimized for the determination of 1.0-10.0 mg of INH in pure and dosage forms. The precision and accuracy of the method have been assessed by the application of lack-of-fit test and other statistical methods. Interference was not caused by RIF and other excipients present in dosage forms. Application of the method for INH assay in tablets and syrups was validated by comparison of the results of proposed method with that of the British Pharmacopoeia (BP) method using F- and t- statistical tests of significance.

Representation Forms of Personal Style on the Fashion Blogs (패션블로그에서 퍼스널 스타일 표현형식)

  • Suh, Sung Eun
    • Fashion & Textile Research Journal
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    • v.16 no.5
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    • pp.689-697
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    • 2014
  • This study aims to analyze the representation forms of bloggers' personal style on the fashion blogs and enlighten their values which can be actively applied to design and marketing in fashion industry. Image representation of fashion bloggers is reflected by the characteristics in the digital environment, which are the creative manipulation of expression and the production of virtual and fantastic images by taking advantage of the composite medium such as images, music, videos, articles, etc. Also real time updates in blog indicate the latest trends in terms of the representation of image as the actual currency. The study conducted case studies of 5 women's personal fashion blogs through the verification of a variety of global fashion media and blog ranking sites: Style Bubble, Style Rookie, The Cherry Blossom Girl, The Blond Salad, and Fashion Toast. Research findings are as follows. First, the application of creative design elements is indicated as symbolic items, self-made designs, DIY, and various mix and match emphasizing design elements such as color, patterns, proportion, etc. Second, the virtual representation is very highlighted on the story telling applied by film like production or digital effect. Third, the commercial application with mainly sponsored wardrobe and designer collaboration indicates promoting a updated trend as well as a specific brand or designer to make their business profits.

THE BERGMAN KERNEL FOR INTERSECTION OF TWO COMPLEX ELLIPSOIDS

  • Beberok, Tomasz
    • Bulletin of the Korean Mathematical Society
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    • v.53 no.5
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    • pp.1291-1308
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    • 2016
  • In this paper we obtain the closed forms of some hypergeometric functions. As an application, we obtain the explicit forms of the Bergman kernel functions for intersection of two complex ellipsoids {$z{\in}\mathbb{C}^3:{\mid}z_1{\mid}^p+{\mid}z_2{\mid}^q$ < 1, ${\mid}z_1{\mid}^p+{\mid}z_3{\mid}^r$ < 1}. We consider cases p = 6, q = r = 2 and p = q = r = 2. We also investigate the Lu Qi-Keng problem for p = q = r = 2.

Effect of Crystal Form(Habit) on Dissolution Rate of Aspirin and Phenacetin (결정형(Habit)이 아스피린과 페나세틴의 용출 속도에 미치는 영향)

  • Cho, Ji-Woon;Sohn, Young-Taek
    • Journal of Pharmaceutical Investigation
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    • v.20 no.2
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    • pp.65-71
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    • 1990
  • Some studies reported physicochemical factors of drugs affecting solubility and dissolution rate. However, few have been reported about pharmaceutical application of crystal forms (habits). Therefore, using acetylsalicylic acid and phenacetin as model substances, we monitored the effects of crystal forms on the dissolution rates.

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