• 대한약학회:학술대회논문집
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• 대한약학회 2000년도 NEW STRATEGY FOR DRUG DEVELOPMENT IN POST-GENOMIC ERA(대한약학회)
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• pp.273.2-274
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• 2000

• Near Infrared Analysis
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• 제1권2호
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• pp.29-33
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• 2000

The identification step of raw drug materials is an indispensible procedure in the GMP manufacturing process within the pharmaceutical industry. However, wet chemistry methods for identification of drug materials, used by the various Pharmacopeia are time-consuming and expensive steps. In this paper, near-infrared spectroscopy (NIRS) has been developed for identifying eleven drug substances including calcium pantothenate, cefaclor, cefoperazone, cephradine, dextromethorphan, ehtambutol, nicotinamide, pyrozinamide, tramadol, vitamin C, and vitamin E. Also the aim of ths work is to consturct a new algorithm for calibration model using soft independence modeling of class analogy (SIMCA) with Malinowskis Indicator Function (IND), which is used for finding the number of principal components of each class of the SIMACA model. The use of NIR technique with pattern recognition to qualify raw materials can make it possible to monitor process in real time as well as to control all procedures in the pharmaceutical industry. As the result, the samples identified of 183 different batches from 11 different compounds were separated clearly by SIMCA with 2nd derivative spectra in the NIR region of 1100∼2400 nm.

• Journal of Pharmaceutical Investigation
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• 제26권4호
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• pp.315-321
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• 1996

It has been indicated that problems associated with insulin iontophoresis are low bioavailability, slow absorption rate and the use of high dosage. Pretreatment of skin as a method of solving these problems was used in alloxan-induced diabetic white rabbits. Skins were treated with skin needle, electric razor, knife razor and scotch tape. Transport data shows that insulin delivery was enhanced significantly by the treatment which disrupt the barrier properties of stratum corneum. The data also shows that insulin absorption lasted for several hours after the cessation of iontophoresis. The degree of skin treatment was estimated by measuring the electrical resistance of skin. When the skins were treated with skin needle and electric razor, the standard deviations of resistance were small, which suggests the possibility of uniform delivery of insulin. The dermal responses after the invasive delivery were evaluated in accordance with OECD Guideline. It seems that electrical resistance of the skin correlate well with the dermal irritation.

• 대한약학회:학술대회논문집
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• 대한약학회 2001년도 Proceedings of the Pharmaceutical Society of Korea
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• pp.238.1-238.1
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• 2001

• Bulletin of the Korean Chemical Society
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• 제13권2호
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• pp.208-210
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• 1992

• 한국콘텐츠학회논문지
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• 제15권8호
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• pp.473-480
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• 2015

본 연구는 우리나라 코스닥 제약회사를 대상으로 내 외부금융이 연구개발투자(R&D)에 미치는 영향을 분석하였다. 실증분석을 위한 표본은 2009년부터 2013년까지 상장된 기업들 중 코스닥 제약회사를 대상으로 하였으며 사용된 전체 표본은 5개년 자료로써 212개 관측치를 가진 불균형패널자료이다. 본 연구에 사용된 주요 변수들 중 개별기업 별 재무자료는 상장회사 협의회의 TS-2000, 금융감독원 전자공시 시스템의 각 기업 사업보고서, NICE신용평가정보의 KISVALUE-III 등의 자료를 통해 직접 수집하였으며, 패널분석을 위해 STATA 12.0을 사용하였다. 연구결과, 첫째 내부금융(유동비율)은 연구개발투자에 긍정적인 영향을 미쳤다. 둘째, 외부금융(부채비율)은 연구개발투자에 부정적인 영향을 미쳤다. 본 연구는 자본시장에서 정보의 비대칭으로 인해 외부금융보다 내부금융이 더 선호됨을 알 수 있다. 즉, 제약기업의 연구개발투자 활성화를 위해 내부금융의 관리 및 정부의 정책적 지원이 필요함을 보여준다.

• 의료법학
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• 제13권2호
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• pp.79-113
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• 2012

This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

• 산경연구논집
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• 제3권1호
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• pp.25-29
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• 2012

The purpose of this study is to examine the development of the pharmaceutical distribution industry. The pharmaceutical industry is are expected to suffer a heavy blow when the Free Trade Agreement (FTA) is introduced, despite its best efforts. Therefore, adequate solutions must be found. Section II introduces the Korean pharmaceutical distribution system and its current situation; Section III explores the distribution system's strengths and weaknesses. Section IV, identifies the problem and possible solutions for the Korean pharmaceutical distribution system; Section V summarizes and concludes this paper and acknowledges its limitations. Finally, this paper has a clear limitation. The lack of objective information and scientific analysis due to the data being based on interviews with company representatives is its most significant shortcoming. However, it offers implications for new directions for future research.

• 대한약학회:학술대회논문집
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• 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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• pp.398.3-399
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• 2002

Quality control by analytical ability with a certain level of precision and accuracy is important. This is true especially in pharmaceutical industries. for a failure in quality control can result in a failure in drug medication. in turn. sometimes a heavy damage to patient's health condition andlor the worst damage to company's reputation. On this backgroun, Kyungki KFDA prepared test pharmaceutical products, which were distributed to 114 pharmaceutical companies in kyungin Province in year 2000. (omitted)

• 한국환경보건학회지
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• 제42권1호
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• pp.34-40
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• 2016

Objectives: This study aims to examine the concentration, diversity, and antibiotic characteristics of penicillin G resistant enterobacteria present in pharmaceutical effluent. Methods: Water sampling was performed from a pharmaceutical company in Gyeonggi-do Province, Korea in March 2015. Water samples were plated in triplicate on tryptic soy agar plates with 32 mg/L of penicillin G. Penicillin G resistant enterobacteria were selected from the effluent and were subjected to 16S rRNA analysis for penicillin G resistant species determination. Identified resistant strains were tested for resistance to various antibiotics. Results: Penicillin G resistant enterobacteria were present at 6.2% as to culturable heterotrophic bacteria. Identified penicillin G resistant enterobacteria exhibited resistance to more than 10 of the antibiotics studied. These resistant bacteria are gram negative and are closely related to pathogenic species. Conclusion: Multi-antibiotic resistant bacteria in the effluent suggest a need for disinfection and advanced oxidation processes for pharmaceutical effluents.