• Title/Summary/Keyword: Pre-clinical strategy

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Case Study on the Effect of IPO on the Technology Commercialization Performance of the New Drug Development Bio Venture Company (증권시장 상장이 신약개발 바이오벤처기업의 기술사업화 성과에 미치는 사례연구)

  • Kim, Ju Young;Ha, Kyu Soo
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.14 no.1
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    • pp.151-166
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    • 2019
  • New drug development requires 10 to 15 years of long time and more than $ 1 billion in funding, ranging from basic research${\rightarrow}$preclinical medicine${\rightarrow}$clinical medicine${\rightarrow}$product approval${\rightarrow}$sales. Many new drug development bio-venture companies will continue to pursue new drug development with funds secured through listing on the securities market. This study focuses on the impact of the listing on the market of bio-venture companies in the development of new drugs. It is necessary to determine whether the increase in registered patent, preclinical, clinical and technology transfer contracts at the time of listing (D) The results of this study are as follows. We also analyzed whether the registered patent, preclinical, and clinical effects had significant effect on technology transfer contracts at two years after listing and listing. The results of the analysis are as follows. First, Korea's new drug development bio-venture firms increased their registered patents but did not increase their pre-clinical, clinical and technology transfer contracts. Second, at the time of listing and two years after listing, pre-employment has a significant effect on Korea's technology transfer contracts and has a significant effect on overseas technology transfer contracts. However, registered patents and clinics have significant influence on technology transfer contracts. Korea 's new drug development bio-venture firms showed patent increase despite the stock market listing, but pre-clinical, clinical and technology transfer contracts did not increase. In order to strengthen technological commercialization of new drug development bio-venture companies in the future, it is required to establish R & D strategy for efficient use of IPO subscription funds, open innovation through strengthening industry-academia-partnerships, and more sophisticated preclinical and clinical strategy establishment.

A comparative study Program Outcome between nursing college students before and After Integrated Clinical Practice (간호대학생의 통합임상실습 전·후 학습성과의 차이)

  • Lee Oi Sun;Noh Yoon Goo
    • The Journal of the Convergence on Culture Technology
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    • v.9 no.4
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    • pp.23-30
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    • 2023
  • This study was attempted to be used as basic data for efficient clinical practice education operation by identifying differences in program outcomes before and after integrated clinical practice of nursing students. Data collection was conducted before and after 6 weeks of integrated clinical practice for 38 nursing college students from July 19 to September 10, 2021 with a single group pre- and post-design. The collected data were analyzed by frequency, Wilcoxon sign rank, and Pearson correlation using SPSS/Win 23.0. After the integrated clinical practice, 1st program outcomes(Care integration)(Z=-4.63, p<.001), 2nd(Core practice)(Z=-3.99, p<.001), 6th(Critical thinking)(Z=-3.60, p<.001) and 11th(Research practice)(Z=-2.76, p=.005) increased significantly compared to before practice. Since integrated clinical practice was found to be an effective practice to improve program outcomes, it is suggested to actively utilize it as a strategy for improving program outcomes.

Implementing Best Practice in Critically Ill Organophosphate Poisoned Patient Through Simulation-Based Learning Program (중환임상중독환자의 상황 인지와 대처 방법에 대한 시뮬레이션 교육의 효과 연구)

  • Lee, Ji Hwan;Chung, Sung Phil;Chung, Hyun Soo
    • Journal of The Korean Society of Clinical Toxicology
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    • v.15 no.1
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    • pp.31-39
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    • 2017
  • Purpose: Despite the clinical and socio-economic impact of acute poisoned patients, many of the treatments are not standardized in Korea. Moreover, no formal training that is specifically focused on clinical toxicology exists. Rather, training and education are conducted case by case in various institutions. This study was conducted to develop a standardized simulation-based clinical toxicology training curriculum for healthcare providers. This program will focus on specific assessment and treatment of critical toxicology patients, specifically those who have been poisoned with organophosphate. Methods: The study was performed using a pre- and post-design to determine the effects of implementation of this program. The study was conducted at eight different urban teaching hospitals in a simulated room in the clinical area. The study was targeted to 19 groups composed of emergency residents and nurses. Simulation-based learning was conducted for each group. Results: All 19 groups achieved the minimum passing score of 75%. Implementation of the program led to improved performance rates for overall management and cooperative moods competency (p<0.01). Inter-rater agreement between the two evaluators was excellent. In general, the participants thought the program was realistic and were able to recognize and improve the competencies needed to care for organophosphate poisoned patients. Conclusion: Simulation-based learning is an effective educational strategy that can be applied to improving and understanding proper care for rare but critical patients. This program was effective at improving team performance and cooperative moods when managing an organophosphate poisoned patient in the Emergency Department.

ANALYSIS OF THE CLINICAL SYMPTOMS AND THE TEMPOROMANDIBULAR JOINT DISK BY MAGNETIC RESONANCE IMAGING AFTER CONSERVATIVE TREATMENT WITH ANTERIOR REPOSITIONING SPLINT (측두하악관절 환자의 전방재위치장치 치료 전후의 임상증상 및 자기공명영상을 이용한 관절원판 변화의 분석)

  • Myoung, Shin-Won;Park, Je-Uk
    • Maxillofacial Plastic and Reconstructive Surgery
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    • v.28 no.2
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    • pp.136-142
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    • 2006
  • Temporomandibular joint(TMJ) disorders have characteristic clinical findings such as pain, joint sound, and abnormal jaw function. With the rapid progress in TMJ imaging techniques, magnetic resonance imaging(MRI) especially provides the clinician and researcher with the ability to evaluate TMJ disorders(effusion, anterior disk displacement) and the hard and soft tissue of the TMJ. In order to manage the internal derangement of TMJ such as anterior disk displacement, the so-called appliance therapy is commonly used. This technique became the treatment of choice before surgical intervention by many practitioners. The purpose of the present study was to evaluate and determine the efficacy of anterior repositioning splint by means of the change of the position of the disk through pre- and post-treatment MRI. MRI and clinical symptom were carefully recorded in TMJ disorder patients. The relationship between TMJ symptoms such as pain, clicking sound, and disk displacement and effusion in MRI were analyzed. Then, splint therapy was applied for 3 months according to our protocol; at day 1, patients should wear 24 hours, in order to accomodate the splint and then, wearing time is reduced to 12 hours per day for one month. During next 2 months, it is tapered to 8 hours per day according to the evaluation of the clinical symptoms. Post-treatment MRI was obtained after 3 month protocol. This treatment strategy improved the clinical symptoms of TMJ disorder, and effusion and articular disk position showed a significant change. In conclusion, a treatment modality using an anterior repositioning splint therapy is an appropriate method for temporomandibular disorder patients.

Natural Products for Cancer-Targeted Therapy: Citrus Flavonoids as Potent Chemopreventive Agents

  • Meiyanto, Edy;Hermawan, Adam;Anindyajati, Anindyajati
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.2
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    • pp.427-436
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    • 2012
  • Targeted therapy has been a very promising strategy of drug development research. Many molecular mechanims of diseases have been known to be regulated by abundance of proteins, such as receptors and hormones. Chemoprevention for treatment and prevention of diseases are continuously developed. Pre-clinical and clinical studies in chemoprevention field yielded many valuable data in preventing the onset of disease and suppressing the progress of their growth, making chemoprevention a challenging and a very rational strategy in future researches. Natural products being rich of flavonoids are those fruits belong to the genus citrus. Ethanolic extract of Citrus reticulata and Citrus aurantiifolia peels showed anticarcinogenic, antiproliferative, co-chemotherapeutic and estrogenic effects. Several examples of citrus flavonoids that are potential as chemotherapeutic agents are tangeretin, nobiletin, hesperetin, hesperidin, naringenin, and naringin. Those flavonoids have been shown to possess inhibition activity on certain cancer cells' growth through various mechanisms. Moreover, citrus flavonoids also perform promising effect in combination with several chemotherapeutic agents against the growth of cancer cells. Some mechanisms involved in those activities are through cell cycle modulation, antiangiogenic effect, and apoptosis induction.Previous studies showed that tangeretin suppressed the growth of T47D breast cancer cells by inhibiting ERK phosphorylation. While in combination with tamoxifen, doxorubicin, and 5-FU, respectively, it was proven to be synergist on several cancer cells. Hesperidin and naringenin increased cytotoxicitity of doxorubicin on MCF-7 cells and HeLa cells. Besides, citrus flavonoids also performed estrogenic effect in vivo. One example is hesperidin having the ability to decrease the concentration of serum and hepatic lipid and reduce osteoporosis of ovariectomized rats. Those studies showed the great potential of citrus fruits as natural product to be developed as not only the source of co-chemotherapeutic agents, but also phyto-estrogens. Therefore, further study needs to be conducted to explore the potential of citrus fruits in overcoming cancer.

Toxicoinformatics: The Master Key for Toxicogenomics

  • Lee, Wan-Sun;Kim, Yang-Seok
    • Molecular & Cellular Toxicology
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    • v.1 no.1
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    • pp.13-16
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    • 2005
  • The current vision of toxicogenomics is the development of methods or platforms to predict toxicity of un characterized chemicals by using '-omics' information in pre-clinical stage. Because each chemical has different ADME (absorption, distribution, mechanism, excretion) and experimental animals have lots of variation, precise prediction of chemical's toxicity based on '-omics' information and toxicity data of known chemicals is very difficult problem. So, the importance of bioinformatics is more emphasized on toxicogenomics than other functional genomics studies because these problems can not be solved only with experiments. Thus, toxicoinformatics covers all information-based analytical methods from gene expression (bioinformatics) to chemical structures (cheminformatics) and it also deals with the integration of wide range of experimental data for further extensive analyses. In this review, the overall strategy to toxicoinformatics is discussed.

The Development and Effects of a Tailored Simulation Learning Program for New Nursing Staffs in Intensive Care Units and Emergency Rooms (중환자실과 응급실 초보간호사를 위한 맞춤형 시뮬레이션 학습프로그램 개발 및 효과)

  • Kim, Eun Jung;Kang, Hee-Young
    • The Journal of Korean Academic Society of Nursing Education
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    • v.21 no.1
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    • pp.95-107
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    • 2015
  • Purpose: The purpose of this study was to develop a tailored simulation learning (SL) program and to evaluate the effects of the program on the clinical competency, clinical decision-making competency, and communicative competency of new nursing staffs in intensive care units (ICU) and emergency rooms (ER). Methods: In this quasi-experimental study, fifteen nurses were assigned to the experimental group and fifteen to the control group. The experimental group was given the SL program of four sessions, whereas the lectures of four sessions were given to the control group. Data were analyzed using a $x^2$-test, Mann-Whitney U test, and Kruskal-Wallis test with an SPSS program. Analysis of covariance was used to treat the covariate of pre communicative competency between the experimental and control groups. Results: Based on the education needs of new nursing staffs in ICUs and ERs, three learning scenarios and one evaluating scenario were developed for the SL program. The score for clinical competency, clinical decision-making competency, and communicative competency were significantly higher in the experimental group compared with the control group. Conclusion: The SL program is an effective learning strategy for new nursing staffs in ICUs and ERs. These findings suggest that an SL program be offered as an alternative for new nurse orientation and continuing nurse education.

The Effects of Video-based Peer assisted Learning in Standardized Patients Simulation: Pre and Post Operative Care (표준화 환자 시뮬레이션 실습교육에서 동영상을 활용한 동료학습의 효과: 수술 전후 간호를 중심으로)

  • Park, In-Hee;Shin, Sujin
    • Korean Journal of Adult Nursing
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    • v.27 no.1
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    • pp.73-82
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    • 2015
  • Purpose: This study examined the effects of peer assisted learning (PAL) using video recordings in standardized patients (SP) simulation. Methods: A mixed-method approach was adopted, in which quantitative data were supplemented with qualitative data. Research participants consisted of 49 nursing students, 24 of whom were assigned to the experimental group, and 25 to the control group. The 12 item instrument was used to measure perioperative care knowledge, while performance confidence was assessed with the 10 item questionnaire, and clinical critical thinking skills with the Clinical Critical Thinking Skill Test (CCTS). Qualitative data were collected using a reflective journaling and in-depth interviews. Results: Participants in the experimental group exhibited significantly higher levels of knowledge than those in the control group (t=5.43, p<.001), and were significantly more confident in their performances (F=52.33, p<.001). However, no significant differences were found between the experimental and the control groups with regard to CCTS (t=0.72, p=.477). A qualitative content analysis was conducted using the interview and reflective journaling data, in which six major themes were elicited from three codes. Conclusion: PAL employing video recordings is expected to be utilized as a teaching and learning strategy in simulation-based nursing practicum with greater frequency and longer period, given the positive effects observed in this study.

Endovascular Treatment of Vertebral Artery Dissecting Aneurysms That Cause Subarachnoid Hemorrhage : Consideration of Therapeutic Approaches Relevant to the Angioarchitecture

  • Lim, Seung Hoon;Shin, Hee Sup;Lee, Seung Hwan;Koh, Jun Seok
    • Journal of Korean Neurosurgical Society
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    • v.58 no.3
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    • pp.175-183
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    • 2015
  • Objective : Intracranial ruptured vertebral artery dissecting aneurysms (VADAns) are associated with high morbidity and mortality when left untreated due to the high likelihood of rebleeding. The present study aimed to establish an endovascular therapeutic strategy that focuses specifically on the angioarchitecture of ruptured VADAns. Methods : Twenty-three patients with ruptured VADAn received endovascular treatment (EVT) over 7 years. The patient group included 14 women (60.9%) and 9 men (39.1%) between the ages of 39 and 72 years (mean age 54.2 years). Clinical data and radiologic findings were retrospectively analyzed. Results : Four patients had aneurysms on the dominant vertebral artery. Fourteen (61%) aneurysms were located distal to the posterior inferior cerebellar artery (PICA). Six (26%) patients had an extracranial origin of the PICA on the ruptured VA, and 2 patients (9%) had bilateral VADAns. Eighteen patients (78%) were treated with internal coil trapping. Two patients (9%) required an adjunctive bypass procedure. Seven patients (30%) required stent-supported endovascular procedures. Two patients experienced intra-procedural rupture during EVT, one of which was associated with a focal medullary infarction. Two patients (9%) exhibited recanalization of the VADAn during follow-up, which required additional coiling. No recurrent hemorrhage was observed during the follow-up period. Conclusion : EVT of ruptured VADAns based on angioarchitecture is a feasible and effective armamentarium to prevent fatal hemorrhage recurrence with an acceptable low risk of procedural complications. Clinical outcomes depend mainly on the pre-procedural clinical state of the patient. Radiologic follow-up is necessary to prevent hemorrhage recurrence after EVT.

Pulmonary stenosis and pulmonary regurgitation: both ends of the spectrum in residual hemodynamic impairment after tetralogy of Fallot repair

  • Yoo, Byung Won;Park, Han Ki
    • Clinical and Experimental Pediatrics
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    • v.56 no.6
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    • pp.235-241
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    • 2013
  • Repair of tetralogy of Fallot (TOF) has shown excellent outcomes. However it leaves varying degrees of residual hemodynamic impairment, with severe pulmonary stenosis (PS) and free pulmonary regurgitation (PR) at both ends of the spectrum. Since the 1980s, studies evaluating late outcomes after TOF repair revealed the adverse impacts of residual chronic PR on RV volume and function; thus, a turnaround of operational strategies has occurred from aggressive RV outflow tract (RVOT) reconstruction for complete relief of RVOT obstruction to conservative RVOT reconstruction for limiting PR. This transformation has raised the question of how much residual PS after conservative RVOT reconstruction is acceptable. Besides, as pulmonary valve replacement (PVR) increases in patients with RV deterioration from residual PR, there is concern regarding when it should be performed. Regarding residual PS, several studies revealed that PS in addition to PR was associated with less PR and a small RV volume. This suggests that PS combined with PR makes RV diastolic property to protect against dilatation through RV hypertrophy and supports conservative RVOT enlargement despite residual PS. Also, several studies have revealed the pre-PVR threshold of RV parameters for the normalization of RV volume and function after PVR, and based on these results, the indications for PVR have been revised. Although there is no established strategy, better understanding of RV mechanics, development of new surgical and interventional techniques, and evidence for the effect of PVR on RV reverse remodeling and its late outcome will aid us to optimize the management of TOF.