Primary health care providers play a critical role in maintaining public health, and the appropriate use of pharmaceutical products is one of the major parts of their practice. This series of articles, entitled 'Clinical Pharmacology Review for Primary Health Care Providers,' is intended to help primary health care providers select more appropriate prescriptions for frequently used drugs based on up-to-date information. We expect that this effort will contribute to improvements in public health and diminish unnecessary drug use.
Histamine Antagonists* ; Pharmaceutical Preparations ; Pharmacology ; Pharmacology, Clinical* ; Prescriptions ; Primary Health Care* ; Public Health

In the published version of this article, the contents of Table 1 (‘Demographic characteristics of subjects’) are incorrect.

The number of clinical trials sponsored by global pharmaceutical companies performed in countries other than the U.S. and Western Europe has been steadily increasing over the past decade. Among those emerging countries, Korea deserves attention for its rapid growth in the number of trials and sites. As of 2009, Korea was ranked the tenth country in the number of clinical trials registered at http://clinicaltrials.gov. This is remarkable growth given that it was not included in the top 30 countries in 2005. High population density, qualified medical professionals, regulatory changes including Investigational New Drug-New Drug Application (IND/NDA) separation, acceptance of International Conferences on Harmonization-Good Clinical Practices (ICH-GCP) by Korea Food&Drug Administration (KFDA), and governmental policies to boost clinical trials were the most influential factors that caused such an outstanding achievement. The Korean National Enterprise for Clinical Trials (KoNECT), an organization founded to lead initiatives to improve the milieu for clinical trials, has been playing a pivotal role in the steering of 15 regional clinical centers designated by the government. Based upon improvements in infrastructure so far, diversity in therapeutic areas and the proportion of early phase trials are expected to grow. Korea has grown to be one of the major countries in the clinical trial market, which was made possible by the cooperation of industry, academia and government. Further investment and efforts to solve current challenges will allow such growth to continue into the next decade.
Achievement ; Congresses as Topic ; Europe ; Investments ; Korea ; Population Density

More than 60 antiviral agents for various infectious diseases such as herpes, hepatitis, influenza, and AIDS are currently prescribed worldwide. Among the viral infections, hepatitis B and influenza are those frequently seen in primary care situations in Korea. This review discusses the anti-hepatitis B (HBV) drugs entecavir and adefovir, and the anti-influenza drugs oseltamivir and zanamivir. In addition, the pharmacology and therapeutic guidance suggested by the Korean Association for the Study of the Liver were reviewed for entecavir and adepovir, the most frequently prescribed anti-HBV drugs. For influenza, oseltamivir is commonly used despite debates on neuropsychiatric safety issues and zanamivir may be used when an inhalation form is necessary. Although currently used drugs show considerable clinical efficacy, efforts to optimize their use and further research to find new molecules that may overcome their limitations are necessary.
Adenine ; Antiviral Agents ; Communicable Diseases ; Guanine ; Hepatitis ; Hepatitis B ; Influenza, Human ; Inhalation ; Korea ; Liver ; Organophosphonates ; Oseltamivir ; Primary Health Care ; Zanamivir

Vaccination is regarded as one of the biggest triumphs in the history of medicine. We are living in the most successful period of vaccine development. The accumulation of multidisciplinary knowledge and the investment of massive funding have enabled the development of vaccines against many infectious diseases as well as other diseases including malignant tumors. The paradigm of clinical vaccine evaluation and licensure has also been modernized based on scientific improvements and historical experience. However, there remain a number of hurdles to overcome. Continuous efforts are focused on increasing the efficacy and reducing the risks related to vaccine use. Cutting-edge knowledge about immunology and microbiology is being rapidly translated to vaccine development. Thus, physicians and others involved in the clinical development of vaccines should have sufficient understanding of the recent developmental trends in vaccination and the diseases of interest.
Allergy and Immunology ; Communicable Diseases ; Financial Management ; History of Medicine ; Investments ; Licensure ; Vaccination ; Vaccines

No abstract available.

Despite long-term research achievements, the development of cell therapy (CT) products remains challenging. This is because the risks experienced by the subject and therapeutic effects in the clinical trial stage are unclear due to the various uncertainties of CT when administered to humans. Nevertheless, as autologous cell products for systemic administration have recently been approved for marketing, CT product development is accelerating, particularly in the field of unmet medical needs. The human experience of CT remains insufficient compared with other classes of pharmaceuticals, while there are countless products for clinical development. Therefore, for many sponsors, understanding the rationale of human application of an investigational product based on the consensus and improving the ability to apply it appropriately for CT are necessary. Thus, defining the level of evidence for safety and efficacy fundamentally required for initiating the clinical development and preparing it using a reliable method for CT. Furthermore, the expertise should be strengthened in the design of the first-in-human trial, such as the starting dose and dose-escalation plan, based on a sufficiently acceptable rationale. Cultivating development professionals with these skills will increase the opportunity for more candidates to enter the clinical development phase.

The importance of precise information and knowledge on the initial estimates (IEs) in modeling has not been paid its due attention so far. By focusing on the IE, this tutorial may serve as a practical guide for beginners in pharmacometrics. A 'good' set of IEs rather than arbitrary values is required because the IEs where NONMEM kicks off its estimation may influence the subsequent objective function minimization. To provide NONMEM with acceptable IEs, modelers should understand the exact meaning of THETA, OMEGA and SIGMA based on physiology. In practice, problems related to the value of the IE are more likely to occur for THETAs rather than the random-effect terms. Because it is almost impossible for a modeler to give a precise IE for OMEGAs at the beginning, it may be a good practice to start at relatively small IEs for them. NONMEM may fail to converge when too small IEs are provided for residual error parameters; thus, it is recommended to give sufficiently large values for them. The understandings on the roles, meanings and implications of IEs even help modelers in troubleshooting situations which frequently occur over the whole modeling process.
Physiology

Primary health care providers play a critical role in maintaining public health, and the appropriate prescription of pharmaceutical products is a major component of their practice. This series of articles entitled 'Clinical Pharmacology Review for Primary Health Care Providers' is intended to help primary health care providers select more appropriate prescriptions for frequently used drugs based on up-to-date information. We expect that this effort will contribute to improvements in public health and diminish unnecessary drug use.
Drug Interactions ; Pharmaceutical Preparations ; Pharmacology ; Pharmacology, Clinical* ; Prescriptions ; Primary Health Care* ; Public Health ; Steroids*

PURPOSE: A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea. MATERIALS AND METHODS: The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers were excluded in a screening step. Immune response was measured by a hemagglutination inhibition (HI) assay. RESULTS: The seroprotection rates against A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2009 were 74.42% [95% confidence interval (CI): 61.38–87.46], 72.09% (95% CI: 58.69–85.50), and 86.05% (95% CI: 75.69–96.40), respectively. Calculated seroconversion rates were 74.42% (95% CI: 61.38–87.46), 74.42% (95% CI: 61.38–87.46), and 79.07% (95% CI: 66.91–91.23), respectively. There were 25 episodes of solicited local adverse events in 21 subjects (47.73%), 21 episodes of solicited general adverse events in 16 subjects (36.36%) and 5 episodes of unsolicited adverse events in 5 subjects (11.36%). All adverse events were grade 1 or 2 and disappeared within three days. CONCLUSION: The immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial.
Adult* ; Hemagglutination ; Humans ; Influenza Vaccines* ; Influenza, Human* ; Korea ; Male ; Mass Screening ; Seroconversion