• 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.

• Nuclear Medicine and Molecular Imaging
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• 제41권6호
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• pp.525-529
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• 2007

Regulation for the radiopharmaceuticals should be reasonably different from that of other drugs. Radiopharmaceuticals are always used by compounding based on the doctor's order, have short half life and very low administration dose. Its pharmacological effect is not from its chemical effect but from radiation. The background for exploratory IND (Investigational New Drug) explained by the FDA was to reduce the time and resources expended on candidate products that are unlikely to suceed, new tools are needed to distinguish earlier in the process those candidates that hold promise from those that do not. In this review, basic concept for exploratory IND and RDRC guideline is summarized and various suggestions for improving and expediting procedure for new radiopharmaceutical development would be described.

• 대한임상약리학회:학술대회논문집
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• 대한임상약리학회 2002년도 제11차 추계학술대회
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• pp.47-54
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• 2002

• 대한약학회:학술대회논문집
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• 대한약학회 2005년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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• pp.162-163
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• 2005

• Journal of Pharmaceutical Investigation
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• 제10권3호
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• pp.51-77
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• 1980

A comparison of worldwide drug registration requirements on scientific data required by the different regulatory authorities for the investigational new drug and new drug application for human uses was briefly reviewed and as one of administrative processings on review and evaluation of applications, the functions of scientific advisory committees were reviewed.

• 한국수의병리학회지
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• 제1권2호
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• pp.91-96
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• 1997

General steps in the discovery and development of novel drugs in the United States are presented. The first step is the discovery of novel drugs. Brief histories and mechanisms of a few novel drugs in the American market are outlined. In this presentation preclinical animal toxicologic studies (drug safety evaluateion) are emphasized in regard to drug development. When preclinical animal studies have defined the toxicity and the doses at which it occurs an Investigational new Drug Application (IND) is submitted to the Food and Drug Administration (FDA) An IND notifies the FDA the intention to begin testing a novel drug in human subjects.

• 대한예방한의학회지
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• 제18권1호
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• pp.23-41
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• 2014

Objective : The purpose of this study was to lay the groundwork for understanding the details and scope of the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and new drugs from natural products that are present in the medical field and the medical industry. Possible solutions are proposed in the end. Method : I analyzed the changes in definition of medicinal products since 1945 that have been used in relevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New Drug Application and Investigational New Drug Application). Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceutical industry, such as the establishment of dualistic medical and pharmaceutical System and the introduction of the substance patent. Due to those changes, boundaries of Western medicinal products and health food expanded, while those of herbal medicine products relatively downscaled. Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs from Natural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceutical System.

• 보건의료산업학회지
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• 제14권1호
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• pp.55-65
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• 2020

Objectives: To provide guidance for agency planning by identifying barriers faced by Korean pharmaceutical companies in global regulatory affairs. Methods: A questionnaire survey on global regulatory affairs was administered by email to personnel at Korean pharmaceutical companies. From a total of 60, 28 responses were collected. Respondents' companies were classified as small-sized or large-sized, based on whether their annual sales amounted to KRW 100 billion. Results: Small-sized companies were experiencing greater difficulties in receiving drug approvals from advanced countries, particularly during the Investigational New Drug (IND) and Good Manufacturing Practice (GMP) processes. Conclusions: Support measures to specifically help small-sized companies enter more advanced markets and further improved global regulatory guidelines that can meet large-sized companies' expectations are needed. Moreover, domestic and global regulatory standards should be harmonized to benefit both groups.

• 대한한의학회지
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• 제31권3호
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• pp.1-7
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• 2010

Objectives: To introduce to TKM scientific dose conversion methods of human to animal or animal to human for new drug investigations. Methods: We searched guidelines of the FDA and KFDA, and compared them with references for drug-dose conversion from various databases such as PubMed and Google. Then, we analyzed the potential issues and problems related to dose conversion in safety documentation of new herbal drugs based on our experiences during Investigational New Drug (IND) applications of TKM. Results: Dose conversion from human to animal or animal to human must be appropriately translated during new drug development. From time to time, investigators have some difficulty in determining the appropriate dose, because of misunderstandings of dose conversion, especially when they estimate starting dose in clinical or animal studies to investigate efficacy, toxicology and mechanisms. Therefore, education of appropriate dose calculation is crucial for investigators. The animal dose should not be extrapolated to humans by a simple conversion method based only on body weight, because many studies suggest the normalization method is based mainly on body surface area (BSA). In general, the body surface area seems to have good correlation among species with several parameters including oxygen utilization, caloric expenditure, basal metabolism, blood volume and circulating plasma protein. Likewise, a safety factor should be taken into consideration when deciding high dose in animal toxicology study. Conclusion: Herein, we explain the significance of dose conversion based on body surface area and starting dose estimation for clinical trials with safety factor.

• Biomolecules & Therapeutics
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• 제25권5호
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• pp.461-470
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• 2017

Anticoagulant drugs, like vitamin K antagonists and heparin, have been the mainstay for the treatment and prevention of venous thromboembolic disease for many years. Although effective if appropriately used, traditional anticoagulants have several limitations such as unpredictable pharmacologic and pharmacokinetic responses and various adverse effects including serious bleeding complications. New oral anticoagulants have recently emerged as an alternative because of their rapid onset/offset of action, predictable linear dose-response relationships and fewer drug interactions. However, they are still associated with problems such as bleeding, lack of reversal agents and standard laboratory monitoring. In an attempt to overcome these drawbacks, key steps of the hemostatic pathway are investigated as targets for anticoagulation. Here we reviewed the traditional and new anticoagulants with respect to their targets in the coagulation cascade, along with their therapeutic advantages and disadvantages. In addition, investigational anticoagulant drugs currently in the development stages were introduced.