• Proceedings of the PSK Conference
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• 2000.10a
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• pp.273.2-274
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• 2000

• Near Infrared Analysis
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• v.1 no.2
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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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• v.26 no.4
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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.

• Proceedings of the PSK Conference
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• 2001.04a
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• pp.238.1-238.1
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• 2001

• Bulletin of the Korean Chemical Society
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• v.13 no.2
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• pp.208-210
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• 1992

• The Journal of the Korea Contents Association
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• v.15 no.8
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• pp.473-480
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• 2015

The purpose of this study is to analyze the influence of the cash flow of pharmaceutical companies on R&D investment. 143 pharmaceutical companies listed in the KOSDAQ market from 2009 to 2013. Financial statements and comments in general and internal transactions were extracted from TS-2000 of the Korea Listed Company Association (KLCA), and data related to stock price was extracted from KISVALUE-III of NICE Information Service Co., Ltd. STATA 12.0 was used as the statistical package for panel analysis. The summary of the findings and the interpretation of the significance of this are as follows: First, the current ratio (internal finance) had a positive influence on R&D investment. Second, the debt ratio (external finance) had a negative influence on R&D investment. The pharmaceutical company prefers internal funds to external funds due to the asymmetry of information in the loan markets. In other words, this shows why internal finances have a significant influence on R&D investment at pharmaceutical companies.

• The Korean Society of Law and Medicine
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• v.13 no.2
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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.

• The Journal of Industrial Distribution & Business
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• v.3 no.1
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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.

• Proceedings of the PSK Conference
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• 2002.10a
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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)

• Journal of Environmental Health Sciences
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• v.42 no.1
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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.