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National statistical data for diagnostic radiation exposure in Republic of Korea were collected from four public institutes and government agencies during the period 2006-2013. The data were pooled, reclassified and analysed. A total of 1574 million exposures occurred during the study period. To evaluate the effective diagnostic radiation exposure dose, the dose conversion factors developed by the Korea Food and Drug Administration were applied. The number of diagnostic radiation exposures was 197 million per year. The collective effective dose averaged 64 043 man Sv y-1, and the annual per caput effective dose averaged 1.27 mSv-1. The annual per caput effective dose in 2013 was 1.54 mSv compared with 0.89 mSv in 2006, a marked increase of 73.9 % over the study period. These research data, compiled from reliable sources within the public health system of Republic of Korea, demonstrate a trend of increasing diagnostic radiation exposure and provide valuable information for further research. [ABSTRACT FROM AUTHOR]

This study was conducted to investigate the toxic metal content (Pb, As, Cd and Hg) of 52 frequently prescribed herbal medicines and to identify herbal medicines that exceed the Korea Food and Drug Administration (KFDA) maximum limits. A total of 3534 samples, including 1966 domestic samples and 1568 imported samples, were analysed using an Inductively Coupled Plasma-Mass Spectrometer (ICP-MS). Total amounts of Pb, As, Cd and Hg were significantly different between domestic (0.63 mg kg−1) and imported (0.81 mg kg−1) medicines (p < 0.05). Among the 52 kinds of samples, 4 kinds of herbs required quality control for Pb and 12 kinds of herbs required quality control for Cd. No sample contained As and Hg above the limits. [ABSTRACT FROM AUTHOR]

Objective: As per the requirement of Korean Food and Drug Administration, this post-marketing surveillance was conducted in Korea to evaluate the safety and reactogenicity of Poliorix™ following its introduction in 2006. Methods: In this open, multicenter study, the vaccine was administered as per the current practice of Korean doctors and in reference to the guidebook by the Korean Pediatric Society and as indicated in the Korean label which was as follows - for primary vaccination three doses were given to infants at ages 2, 4 and 6 months whereas, for the booster dose a single dose was given to children aged 4-6 years. Safety data during this six year surveillance was collected using diary cards which were distributed to the parents to record adverse events. Results: A total of 639 subjects were enrolled into the study. Of these, 617 subjects and 22 subjects received the vaccine as a primary and booster dose, respectively. At least one unsolicited symptom was reported in 11.4% (73/639) of the subjects during the 7-day follow-up period; upper respiratory tract infection (2.5%;16/639) was the most frequently reported unsolicited symptom. One subject reported at least one unsolicited symptom (gastroenteritis) of grade 3 intensity within the 31-day post-vaccination period. Approximately 1.7% (11/639) of subjects reported 13 serious adverse events (SAEs). All SAEs were resolved by the end of the study. Conclusion: In Korea, primary and booster vaccination with Poliorix™ was well-tolerated in healthy subjects when administered according to the prescribing information as part of routine clinical practice. [ABSTRACT FROM AUTHOR]

Background To establish the consensus about the conditions for undertaking clinical trials in xenocorneal transplantation in Korea, specific issues regarding the xenocorneal transplantation on ethical and regulatory aspects are addressed, and the guidelines to conduct clinical trial of the xenocorneal transplantation are proposed. Method and Results Chapter 1 reviews the key ethical requirements and progress of a Korean regulatory framework for clinical trials of xenocorneal transplantation. Chapters 2-7 provide recommendations on source pigs, quality control of porcine corneal procurement, preclinical efficacy required to justify a clinical trial, strategies to prevent transmission of porcine endogenous retrovirus ( PERV), patient selection for clinical trials, and informed consent in xenocorneal transplantation using either cellularized or decellularized porcine graft, which are essentially based on the International Xenotransplantation Association ( IXA) islet xenotransplantation consensus statement. The consensus statement of the inclusion criteria for the patients' selection has been made by the executive board members in Korean External Eye Disease Society. Conclusions This consensus statement will be a good initiative for Korean Food and Drug Administration to discuss final regulatory guidelines in conducting clinical trials of xenocorneal transplantation in Korea and for International Xenotransplantation Association to develop International Consensus Standards of Xenocorneal Transplantation. [ABSTRACT FROM AUTHOR]

Abstract: Soy products are primarily composed of proteins, phytochemicals such as isoflavones, soy lipids, and carbohydrates. Recently, soy isoflavones with l-carnitine were reported to exhibit anti-obesity effects in mice. FCD, a combination of soybean extract and l-carnitine, is a newly developed food substance. As a part of its safety assessment, acute and 13-week subchronic toxicity studies were performed in a total of 100 Sprague–Dawley (SD) rats. In the acute study, a single limit dose of 2000mg/kg was orally administered to five male and five female rats. No adverse effects or mortality was observed during a 14-day period or upon gross pathological examination. In the subchronic study, FCD was orally administered in daily doses of 500, 1000, and 2000mg/kg for 13weeks, resulting in no mortality, and no changes in hematological and serum biochemistry parameters, gross pathology or histopathology. However, body weights of females were significantly decreased 10weeks after treatment at an average of 2000mg/kg. In addition, a slight decrease in mean food and water consumption was observed at the same dose level for 13weeks. Therefore, the no-observed-adverse-effect-level (NOAEL) of FCD was considered to be 2000mg/kg for male and 1000mg/kg for female SD rats. [Copyright &y& Elsevier]

The cadmium (Cd) content of rice grain grown in metal-contaminated paddy soils near abandoned metal mines in South Korea was found to exceed safety guidelines (0.2 mg Cd kg) set by the Korea Food and Drug Administration (KFDA). However, current remediation technologies for heavy metal-contaminated soils have limited application with respect to rice paddy soils. Laboratory and greenhouse experiments were conducted to assess the effects of amending contaminated rice paddy soils with zerovalent iron (ZVI), lime, humus, compost, and combinations of these compounds to immobilize Cd and inhibit Cd translocation to rice grain. Sequential extraction analysis revealed that treatment with the ameliorants induced a 50-90% decrease in the bioavailable Cd fractions when compared to the untreated control soil. When compared to the control, Cd uptake by rice was decreased in response to treatment with ZVI + humus (69%), lime (65%), ZVI + compost (61%), compost (46%), ZVI (42%), and humus (14%). In addition, ameliorants did not influence rice yield when compared to that of the control. Overall, the results of this study indicated that remediation technologies using ameliorants effectively reduce Cd bioavailability and uptake in contaminated rice paddy soils. [ABSTRACT FROM AUTHOR]

Opioids are widely used as painkillers and anesthetics. Though we use opioids to relieve pain, these drugs can induce mood elevation, dependency, and withdrawal symptoms. This is why opioids are controlled-substances. Most physicians think that some substances should be controlled if they have opioid-like pharmacological properties, especially a long duration, preservation of respiration, and dependency. It is noteworthy that short-acting substances, such as midazolam and thiopental, are included in controlled substances. Their abuse is very dangerous because they frequently induce severe respiratory depression due to a narrow therapeutic window. Teaching point of this article is that designation of a new drug as a controlled substance requires scientific evidence of its link to dependency and/or withdrawal symptoms. However, this does not require abusers' convenience (long duration) or safety (maintenance of respiration). The authors present the addiction and abuse patterns of propofol as an reasons for the Korean Food and Drug Administration to designate propofol as a controlled substance. As a future study, an animal and/or a clinical model for dependency is needed to identify addictive substances. Though several neurotransmitters and their loci in the central nervous system have been studied, the precise mechanism for addiction is unknown. Also, it should be recognized that the potential for drug addiction and abuse could be masked in the early marketing period of a new drug. Physicians should monitor patients' responses carefully when they deal with the drug. [ABSTRACT FROM AUTHOR]

The migration levels of bisphenol A (BPA) were analyzed in food samples by high-performance liquid chromatography (HPLC) from polycarbonate (PC) bottles subjected to simulated use by heating with microwave, heating in a boiling water bath, or filling them with boiling hot water (100°C). Migration testing performed in PC bottles filled with steamed rice or hot cooked pork, standing at room temperature, or heated in a boiling water bath (100°C) showed that BPA was not detected at the limit of detection (LOD) of 1 μg/L (ppb). In contrast, heating by microwaving to 100°C for 9 min increased BPA migration levels from 6 to 18 ppb and from 5 to 15 ppb for steamed rice or for cooked pork, respectively. In addition, 3 different PC bottles were tested by filling them with boiling hot water (100°C) and leaving them to stand at room temperature for up to 3 h. The mean BPA levels from the bottles increased in a time-dependent manner, with the range of not detected (ND) to 2.5 ppb after 60 min. However, none of the PC bottles released BPA at levels that exceed the recently established specific migration limits (SML) of 600 ppb established by European Union and Korea Food and Drug Administration (KFDA). Data suggest that the use of PC plastic bottles in our daily life is considered safe in Korea. [ABSTRACT FROM AUTHOR]

Chinese cabbage has long been consumed as a staple food by the Koreans in various forms of fresh, salted, or fermented as kimchi. To fulfill the off-season demand for this crop, it has become a common practice to be cultivated under greenhouse conditions. Since pesticide residues in/on leafy vegetables have strongly concerned with food safety in the Korean society, the changes of lufenuron residues, in/on Chinese cabbage applied by foliar spraying under greenhouse conditions was investigated. Lufenuron 5% emulsifiable concentrate (EC) was sprayed with diluted solution of recommended and double doses to the crop. The shoots of the cabbage were harvested immediately after spraying, and sequentially the harvests were conveyed to analyze the residual amounts. The deposited level of the analyte in/on Chinese cabbage under greenhouse conditions seemed to be difficult to produce the crop with 0.2 ppm of maximum residue limit (MRL) of the Korea Food and Drug Administration (KFDA). [ABSTRACT FROM AUTHOR]

The article reports that stem cell therapies have been approved by the Korea Food and Drug Administration (KFDA). According to Douglas Sipp, stem cell policy researcher at the RIKEN Center for Developmental Biology, the KFDA is willing to approve the treatment modalities despite limited peer-reviewed data. The stem cell-based drug Hearticellgram-AMI developed by Pharmicell Europe GmbH is highlighted which is used in the treatment of heart attacks.