• Journal of Pharmaceutical Investigation
• /
• 제40권spc호
• /
• pp.9-17
• /
• 2010

Polymorphism has been recognized to be a critical issue throughout the drug product development process. Most of solid phase drugs have polymorphism, which has generated a great deal of interest and the field has been evolving rapidly. Preferably, thermodynamically most stable form of a drug substance is selected to obtain consistent bioavailability over its shelf life and various storage conditions. Moreover, it has the lowest potential for conversion from one polymorphic form to another. However, metastable or amorphous forms may be used intentionally to induce faster dissolution rate for rapid drug absorption and higher efficacy. For pharmaceutical industry, polymorphism is one of the key activities in form selection process together with salt selection. This article introduces the main features in the investigation of solid form selection especially polymorphic behavior with thermodynamic backgrounds, physicochemical properties with solubility, dissolution, and mechanical properties, and characterization techniques for proper analysis. The final form can be recommended based on the physicochemical and biopharmaceutical properties and by the processability, scalability and safety considerations. Pharmaceutical scientists especially in charge of formulation need to be well aware of the above issues to assure product quality.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
• /
• 제22권2호
• /
• pp.67-73
• /
• 2011

The purpose of licensing system is to ensure that the medicines are examined for safety, efficacy and quality. Nevertheless, off-label or unlicensed drug usages in pediatric practice is widespread in Korea and worldwide. Psychotropics are one of the most commonly used off-label or unlicensed drugs. The most valid approach to face this dilemma will be to have more evidences from pediatric pharmacological studies. Clinicians, in addition, need to monitor closely their off-label or unlicensed drug prescriptions to minimize the trial and error in practice. Researchers should publish their experiences and provide guidelines. Pharmaceutical companies, regulatory authorities, and consumer organizations should endeavor altogether for the children's right to get safe and efficacious drugs as adults do. Here, the definition as well as the current status of off-label and unlicensed drug prescriptions will be introduced. Critical issues regarding the off label drugs are discussed. In addition, I will describe the present condition as to the off-label and unlicensed drugs in child and adolescent psychiatry and the authorization process of off-label drug prescription in Korea. Lastly, direction we should like to take in this field will be mentioned.

• Radiation Oncology Journal
• /
• 제36권4호
• /
• pp.265-275
• /
• 2018

Cancer is a complex multifaceted illness that affects different patients in discrete ways. For a number of cancers the use of chemotherapy has become standard practice. Chemotherapy is a use of cytostatic drugs to cure cancer. Cytostatic agents not only affect cancer cells but also affect the growth of normal cells; leading to side effects. Because of this, radiotherapy gained importance in treating cancer. Slaughtering of cancerous cells by radiotherapy depends on the radiosensitivity of the tumor cells. Efforts to improve the therapeutic ratio have resulted in the development of compounds that increase the radiosensitivity of tumor cells or protect the normal cells from the effects of radiation. Amifostine is the only chemical radioprotector approved by the US Food and Drug Administration (FDA), but due to its side effect and toxicity, use of this compound was also failed. Hence the use of herbal radioprotectors bearing pharmacological properties is concentrated due to their low toxicity and efficacy. Notably, in silico methods can expedite drug discovery process, to lessen the compounds with unfavorable pharmacological properties at an early stage of drug development. Hence a detailed perspective of these properties, in accordance with their prediction and measurement, are pivotal for a successful identification of radioprotectors by drug discovery process.

• International Journal of Stem Cells
• /
• 제17권2호
• /
• pp.113-119
• /
• 2024

This report presents guidelines for the systematic management of packaging, storage, transportation, and traceability of source cells used for organoid research. Given the important role of source cells in organoid studies, it is important to ensure the preservation of their quality and integrity throughout transportation and distribution processes. The proposed guidelines, therefore, call for a cohesive strategy through these stages to minimize the risks of contamination, deterioration, and loss-threats that significantly compromise the safety, efficacy, and efficiency of source cells. Central to these guidelines is the quality control measures that include roles and responsibilities across the entire supply chain, with recommendations specific to packaging materials, transportation facilities, and storage management. Furthermore, the need for an integrated management system is emphasized, spanning from source cell collection to the final application. This system is crucial for maintaining the traceability and accountability of source cells, facilitating the sharing, distribution, and utilization on a global scale, and supporting to advance organoid research and development.

• Genomics & Informatics
• /
• 제8권1호
• /
• pp.41-49
• /
• 2010

Statins are competitive inhibitors of hydroxy-3-methyl glutaryl coenzyme A (HMG-CoA) reductase and used most frequently to reduce plasma cholesterol levels and to decrease cardiovascular events. However, statins also have been reported to have undesirable side effects such as myotoxicity and hepatotoxicity associated with their intrinsic efficacy mechanisms. Clinical studies recurrently reported that statin therapy elevated the level of liver enzymes such as ALT and AST in patients suggesting possible liver toxicity due to statins. This observation has been drawn great attention since statins are the most prescribed drugs and statin-therapy was extended to a larger number of high-risk patients. Here we employed rat primary hepatocytes and microarray technique to understand underlying mechanism responsible for statin-induced liver toxicity on cell level. We isolated genes whose expressions were commonly modulated by statin treatments and examined their biological functions. It is of interest that those genes have function related to response to stress in particular immunity and defense in cells. Our study provided the basic information on cellular mechanism of statin-induced cytotoxicity and may serve for finding indicator genes of statin -induced toxicity in rat primary hepatocytes.

• 지역사회간호학회지
• /
• 제17권3호
• /
• pp.387-396
• /
• 2006

Purpose: This cross-sectional study was conducted to investigate the prevalence of health risk behaviors by gender and grade and to examine the correlation between health risk behaviors and self-efficacy in early adolescents. Method: The sample of this study consisted of 1.693 early adolescents recruited from 7 middle schools in S-Gu, Seoul, Korea. Health risk behaviors were measured by the Youth Risk Behavior Surveillance Survey (YRBS). Self-Efficacy was assessed by General Self-Efficacy (GSE). Results: About a third of the subjects had experience in drinking behavior about 19.4% in cigarette smoking (including cases of just one or two puffs), 25.9% in physical fight, 29.1% in thought about killing themselves (suicide-related behavior), 1.5% in drug. More than a half (60.5%) experienced at least one health risk behavior. Female students were more likely to report drinking experience and suicide-related experience. Health risk behaviors were not significantly correlated with self-efficacy in early adolescents. Conclusions: Many early adolescents had experience in health risk behaviors in the past. The findings of this research suggest the necessity of intensive prevention programs in middle school to motivate and prepare students to avoid these behaviors. In addition, these results may help health professionals plan appropriate screening and counselling for health problems in early adolescents.

• 대한치과의사협회지
• /
• 제9권10호
• /
• pp.601-605
• /
• 1971

The authors have reported on the evaluation of remarkable therapeutic results from the use of chymoral against postextracted and post operative swelling, pain, 2nd hemorrhage and muscle spasm. The drug was administered to 8 tablets per day in the oral method and to 47 cases of 9 different kinds of oral diseases. The following are the results of the clinical efficacy of the drugs. 1) As results of the use of chymoral preparation, marked efficacy was observed in 30 cases(70%), moderate efficacy in 14 cases(24%), total efficacy in 47 cases (94%) and obscure efficacy in 3 cases(6%). 2) Postoperative infection by extraction and its complications were nearly all cured within a short time by use of chymoral. 3) The comparatively satisfactory results obtained from the use of antibiotic drugs (especially, penbritin or tetracycline) combined with chymoral.

• 대한본초학회지
• /
• 제22권4호
• /
• pp.1-8
• /
• 2007

Objectives : There are many causes that may affect efficacy of a drug but the time of administration for the Herbal Medicine is among the most important factors. Traditionally, administration of medicine was prohibited during the meal time along with food and the time of administration has been highly regarded in medical practitioners. The rules of administration time are stated in a book titled, "Materia Medica" but it lacked the details and index. Thus, the systemized administration rules for Herbal Medicine were prepared. Methods : The rules were drawn from both ancient teachings and the experiences from modern clinics. Ancient teachings about the administration are focused on treatment of a disease by utilizing biorhythm of the body in accordance of changes in Yin and Yang and Day and Night. Results : It means the medicine should be prepared and administered at the appropriate time of the day and this type of administration method is thought to be superior to the western method such as "once a day" or "twice a day in the morning and evening" that does not take consideration of cold, hot, warm and cool properties of the medicine. If the prescription is assigning appropriate medicine, administration time is an important method of maximizing drug efficacy. Conclusion : With the ancient teaching in mind, it was concluded that, the drug administration time must be determined with regard to properties of the drug and the condition of the patient.

• 한국산학기술학회논문지
• /
• 제14권5호
• /
• pp.2251-2261
• /
• 2013

본 연구는 간호 대학생들의 약물용량계산 능력을 개발, 증진하기 위해 학습용 스마트폰 어플리케이션을 개발하고 평가하기 위한 것이다. 충분한 자료를 근거로 콘텐츠를 구성한 후에 교육용 시스템으로 구현하는 과정으로 개발하였고, 전문가 집단에 의해 평가받았다. 간호대학생 37명을 대상으로 4주간의 중재 후, 참여도에 따른 자료를 SPSS WIN 18.0을 활용하여 분석하였다. 그 결과 어플리케이션의 사용정도에 따라 학습목표의 성취도(${\chi}^2$=10.90, p=.004), 업무 적용도(Z=2.86, p=.004), 수학적 자신감은 유의하게 증진(Z=3.07, p=.002)되었으나, 학업적 효능감에는 차이가 없었다. 본 연구에서 개발된 어플리케이션은 간호 대학생들의 약물용량계산 능력을 강화하는 데 도움을 줄 수 있는 교육용 프로그램이라 여겨지나, 보다 효과적으로 약물계산역량을 향상시키기 위해서는 학업적 효능감을 높이고, 참여를 적극적으로 격려하는 어플리케이션이 개발되어야 할 것이다.

• Journal of Pharmaceutical Investigation
• /
• 제26권4호
• /
• pp.245-256
• /
• 1996

Solid lipid nanoparticles (SLN) have been developed as a new drug delivery system. Although many particulate drug carriers, such as microsphere, liposome, niosome, emulsion, etc. have been introduced, they have some disadvantage; low efficiency of incorporation and stability, lack of reproducibility, and so on. Meanwhile, SLN as a new drug delivery system is known to entrap rugs with a high efficiency and a good reproducibility. Moreover, small size SLN can circulate in blood for a prolonged time. Although many preparation methods were introduced, microfluidization method is recommended to be the most useful. This study was attempted to prepare and evaluate ketoprofen-incorporated SLNs (keto-SLN), which were prepared by two methods, ultrasonication and microfluidization. Keto-SLN was evaluated by measurement of particle size and zeta potential, efficacy of entrapment, sedimentation volume, in virto release pattern. The mean particle size was about $0.1\;{\mu}m$, and the size was dependent on the type and the amount of emulsifier. Zeta potential was negative, $-9{\sim}-13mV$ and entrapment efficacy was very high and stability was good for at least 60 days in the respect of particle size and sedimentation volume ratio. Analgesic effect was also determined as well as pharmacokinetic parameters. The former was comparable to that of that of ketoprofen loaded suspension (keto-sus) and the latter revealed that consistent with the delayed release of keto-SLN. $T_{max}$ was longer than keto-sus. Therefore, keto-SLN was favourable dosage forms in the field of drug delivery system such as anti-cancer, analgesics and anti-inflammatory agents.