Korea Food And Drug Administration Research Articles

Single Oral Dose Toxicity Study of Water Extracts of Polygalae Radix in ICR Mice

The objective of this study was to evaluate the single oral dose toxicity of Polygalae Radix (PR) in male and female mice. PR extract (yield = 18.6%) was administered to ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines (2009-116, 2009). Animals were monitored for the mortality and the changes in body weight, clinical signs and gross observation during 14 days after dosing. Upon necropsy, organ weight and histopathology of 14 principal organs were examined. It was observed that there were no mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations against 14 principal organs related to PR extract up to 2,000 mg/kg. Therefore, 50% lethal dose (LD50) and approximate LD of PR aqueous extracts after single oral treatment in female and male mice were considered over 2000 mg/kg the limited dosages recommended by KFDA Guidelines, respectively.

Single Oral Dose Toxicity Test of Areca catechu Aqueous Extracts in Mice

This study was to evaluate the single dose toxicity of Arecae Semen (AS) in male and female ICR mice. Aqueous extracts of AS (Yield = 13.15%) were administered as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 12 principle organs were examined. We could not find any mortality, clinical signs, and changes in the body and organ weight except for diarrhea. Diarrhea were observed in all three different dosage groups of male mice, and in 2000 mg/kg groups of female mice within 48hrs after administration. In addition, no AS extract related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. Although the 50% lethal dose and approximate lethal dose of AS aqueous extracts in female and male mice were detected as over 2,000 mg/kg ? the limited highest dosage recommended by KFDA guidelines. It should be carefully used in clinics because AS may be induced severe digestive tract disorders.

Single Oral Dose Toxicity Test of Persicae Semen Aqueous Extracts in Mice

Objectives : This study was to evaluate the single dose toxicity of Persicae Semen (PS) in ICR mice. Methods : Aqueous extracts of PS (Yield = 18.60%) were administered as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) guidelines (2009-116, 2009). Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 12 principle organs were examined. Results : Amygdalin contents in PS aqueous extracts were detected as <TEX>$32.50{\pm}5.96{\mu}g/ml$</TEX>. We could not find any PS extracts treatment related mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations up to 2,000 mg/kg in both female and male mice, except for transient and slight loss of locomotion detected in female and male mice treated with 2,000 mg/kg. In addition, pharmacological immunomodulatory effects related findings were also demonstrated in 2,000mg/kg treated female and male mice as hypertrophy and hyperplasia of lymphoid cells in the submandibular lymph nodes. Conclusions : Based on the results of this experiment, the approximate lethal dose (ALD) of PS extracts after single oral treatment in female and male mice were considered above 2,000 mg/kg, respectively. It should be carefully used in clinics because the possibilities of respiratory or neurological disorders were observed when administered over 2,000 mg/kg of PS extract related to amygdalin.

Bioequivalence of Samchundang Berastolin tablet to Jeil Berasil tablet (beraprost sodium 20 μg)

Beraprost sodium, sodium (±)-(1R*,2R*,3aS*,8bS*)-2,3,3a,8b-tetrahydro-2-hydroxy-1-[(E)-(3S*)-3-hydroxy-4-methyl-1-octen-6-ynyl]-1H-cyclopenta[b]benzofuran-5-butyrate), an orally absorbable prostacyclin derivative (PGI2), has marked ischemic symptom treatments like ulcer and pain with chronic arterial occlusion. The purpose of the present study was to evaluate the bioequivalence of two beraprost sodium tablets, Samchundang Berastolin tablet (Samchundang Pharm. Co., Ltd.) and Jeil Berasil tablet (Jeil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of beraprost from the two beraprost sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Thirty-two healthy Korean male volunteers, 23.44 ± 1.48 years in age and 65.95 ± 8.94 kg in body weight, were divided into two groups and a randomized 2 × 2 crossover study was employed. After single administration, three tablets containing 20 μg as beraprost sodium, blood samples were taken at predetermined time intervals and the concentrations of beraprost in serum were determined using a LC/MS/MS method with multiple reaction-monitoring. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as AUCt, Cmax and Tmax were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed AUCt, Cmax and un-transformed Tmax. The results showed that the differences between two formulations based on the reference drug, Jeil Berasil tablet, were 2.12, 0.15 and 4 % for AUCt, Cmax, and Tmax, respectively. There were no sequence effects between two formulations in these parameters. The 90 % confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8–log 1.25 (e.g., log 0.9114–log 1.0912 and log 0.8471–log 1.1253 for AUCt and Cmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Samchundang Berastolin tablet was bioequivalent to Jeil Berasil tablet.

Bioequivalence of Torad tablet 5 mg to Torem tablet 5 mg (torasemide 5 mg)

The purpose of the present study was to evaluate the bioequivalence of two torasemide tablets, Torem (Roche Korea Co., Ltd., Korea, reference drug) and Torad (Samchundang Pharmaceutical Co., Ltd., Korea, test drug) tablet, according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-eight healthy male Korean volunteers, 23.68 ± 1.79 years in age and 67.59 ± 9.87 kg in body weight, were divided into two groups and received each medicine at the torasemide dose of 10 mg in a randomized 2 × 2 crossover study. After a single administration, blood samples were taken at predetermined time intervals and the serum concentrations of torasemide were monitored by an HPLC–UV. The in vitro dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as AUCt (the area under the serum concentration–time curve from time zero to 12 h), Cmax (maximum serum drug concentration), and Tmax (time to reach Cmax) were calculated, and computer programs (equiv test and K-BE test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed AUCt and Cmax. The results showed that the differences between two formulation based on the reference drug, −2.84, −1.22 and 15.91 % for AUCt, Cmax, and Tmax, respectively. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90 % confidence intervals using logarithmically transformed data were within the acceptance range of log0.80 to log1.25 (e.g., log0.9305−log1.0043 and log0.9422−log1.0903 for AUCt and Cmax, respectively). Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Torad tablet and Torem tablet are bioequivalent.

Clinical trials for vaccine development in registry of Korea Food and Drug Administration

Based on the action plan "Ensuring a stable supply of National Immunization Program vaccines and sovereignty of biopharmaceutical products," Korea Food and Drug Administration (KFDA) has made efforts to develop vaccines in the context of self reliance and to protect public health. Along with the recognized infrastructures for clinical trials, clinical trials for vaccines have also gradually been conducted at multinational sites as well as at local sites. KFDA will support to expand six to eleven kinds of vaccines by 2017. In accordance with integrated regulatory system, KFDA has promoted clinical trials, established national lot release procedure, and strengthened good manufacturing practices inspection and post marketing surveillance. Against this backdrop, KFDA will support the vaccine development and promote excellent public health protection.

Systematic review of the effect of coenzyme Q10 on antioxidant capacity while focused on evaluation of claims for health functional food

Although the functional ingredient has been evaluated by the Korea Food and Drug Administration (KFDA) based on scientific evidence, the levels of scientific evidence and consistency of the results might vary according to emerging data. Therefore, periodic re-evaluation may be needed for some functional ingredients. In this study, we re-evaluated scientific evidence for the antioxidant activity of coenzyme Q10 as a functional ingredient in health functional food. Literature searches were conducted using the Medline and Cochrane, KISS, and IBIDS databases for the years 1955-2010 with the search term of coenzyme Q10 in combination with antioxidant. The search was limited to human studies published in Korean, English, and Japanese. Using the KFDA’s evidence based evaluation system for scientific evaluation of health claims, 33 human studies were identified and reviewed in order to evaluate the strength of the evidence supporting a relation between coenzyme Q10 and antioxidant activity. Among 33 studies, significant effects for antioxidant activities were reported in 22 studies and their daily intake amount was 60 to 300 mg. Based on this systematic review, we concluded that there was possible evidence to support a relation between coenzyme Q10 intake and antioxidant activities. However, because inconsistent results have recently been reported, future studies should be monitored.

Systematic review of the effect of omega-3 fatty acids on improvement of blood flow while focused on evaluation of claims for health functional food

Omega-3 polyunsaturated fatty acids are essential fatty acids because humans cannot synthesize them de novo and must obtain them in their diet. Fish and fish oil are rich sources of omega-3 fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Significant evidence of the beneficial role of dietary intake of omega-3 fatty acids in blood flow has been reported and putative mechanisms for improvement of blood flow include anti-thrombotic effects, lowered blood pressure, improved endothelial function, and anti-atherogenic effects. Edible oils containing omega-3 fatty acids were registered as functional ingredients in the Korea Health Functional Food Code. Although omega-3 fatty acids have been evaluated by the Korea Food and Drug Administration (KFDA) based on scientific evidence, periodic re-evaluation may be needed because emerging data related to omega-3 fatty acids have accumulated. Therefore, in this study, we re-evaluated scientific evidence for the effect of omega-3 fatty acids as a functional ingredient in health functional food on improvement of blood flow. A comprehensive literature search was conducted for collection of relevant human studies using the Medline and Cochrane, KISS, and IBIDS databases for the years 1955-2012. Search keywords were used by combination of terms related to omega-3 fatty acids and blood flow. The search was limited to human studies published in Korean, English, and Japanese. Using the KFDA’s evidence based evaluation system for scientific evaluation of health claims, 112 human studies were identified and reviewed in order to evaluate the strength of the evidence supporting a relation between omega-3 fatty acids and blood flow. Among 112 studies, significant effects on improvement of blood flow were reported in 84 studies and the daily intake amount was ranged from 0.1 to 15 g. According to this methodology of systematic review, we concluded that there was possible evidence to support a relation between omega-3 fatty acid intake and blood flow. However, because inconsistent results have recently been reported, future studies should be monitored.

Risk Assessment Principle for Engineered Nanotechnology in Food and Drug

While the ability to develop nanomaterials and incorporate them into products is advancing rapidly worldwide, understanding of the potential health safety effects of nanomaterials has proceeded at a much slower pace. Since 2008, Korea Food and Drug Administration (KFDA) started an investigation to prepare “Strategic Action Plan” to evaluate safety and nano risk management associated with foods, drugs, medical devices and cosmetics using nano-scale materials. Although there are some studies related to potential risk of nanomaterials, physical-chemical characterization of nanomaterials is not clear yet and these do not offer enough information due to their limitations. Their uncertainties make it impossible to determine whether nanomaterials are actually hazardous to human. According to the above mention, we have some problems to conduct the human exposure risk assessment currently. On the other hand, uncertainty about safety may lead to polarized public debate and to businesses unwillingness for further nanotechnology investigation. Therefore, the criteria and methods to assess possible adverse effects of nanomaterials have been vigorously taken into consideration by many international organizations: the World Health Organization, the Organization for Economic and Commercial Development and the European Commission. The object of this study was to develop risk assessment principles for safety management of future nanoproducts and also to identify areas of research to strengthen risk assessment for nanomaterials. The research roadmaps which were proposed in this study will be helpful to fill up the current gaps in knowledge relevant nano risk assessment.

Analysis of cardiovascular events or diabetes mellitus during androgen deprivation therapy in Korean prostate cancer patients

BackgroundADT (Androgen Deprivation Therapy) is widely used as prostate cancer treatment which suppresses serum testosterone and inhibits the cancer cell growth. Since people with prostate cancer have relatively high 5-year...

The Safety Evaluation of a Potent Angiogenic Activator, Synthetic Peptide (SFKLRY-NH2) for the Skin Application

A novel synthetic hexapeptide (SFKLRY-NH2) that displays angiogenic activity has been identified by positional scanning of a synthetic peptide combinatorial library (PS-SPCL). This study was carried out to investigate the irritation of the SFKLRY-NH2 on the skin. The tests were performed on the basis of Korea Food and Drug Administration (KFDA) guidelines. In results, cell toxicity is not appeared for SFKLRY-NH2 in HaCaT cells and B16F10 cells. SFKLRY-NH2 induced no skin irritation at low concentration (10 μM), mild irritation at high concentration (10mM). We consider that this result is helpful for saying about the safety of SFKLRY-NH2 in clinical use.

Mouse Single Oral Dose Toxicity Test of Bupleuri Radix Aqueous Extracts

The aim of this study was to evaluate the single oral dose toxicity of Bupleuri Radix (BR) aqueous extracts, it has been traditionally used as anti-inflammatory agent, in male and female mice. BR extracts (yield = 16.52%) was administered to female and male ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 14 principal organs were examined. As the results, no BR extracts treatment related mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations against 14 principal organs were detected up to 2,000 mg/kg in both female and male mice, except for soft feces and related body weight decrease detected in male mice treated with 2,000 mg/kg. Therefore, LD50 (50% lethal dose) and approximate LD of BR aqueous extracts after single oral treatment in female and male mice were considered over 2000 mg/kg, respectively. Although it was also observed that the possibilities of digestive disorders, like soft feces when administered over 2,000 mg/kg of BR extracts in the present study, these possibilities of digestive disorders can be disregard in clinical use because they are transient in the highest dosages male only.

Propofol Abuse in Professionals

Propofol Abuse in Professionals

Bioequivalence Evaluation of Two Brands of Lisinopril Tablets by in vitro Comparative Dissolution Test and in vivo Bioequivalence Test

The bioequivalence of a test formulation (Nanopril, "test") and a reference formulation ("reference") of lisinopril (CAS 83915-83-7) was demonstrated by in vivo and in vitro tests. The in vivo bioequivalence study in 26 healthy volunteers was designed as a single dose, randomized, double-blind trial with a 2-week washout period between the doses. Prior to the in vivo study, an in vitro comparative dissolution test was performed by the paddle method following the bioequivalence guidance of the Korea Food and Drug Administration (KFDA). By the results of the dissolution test it was demonstrated from the similar and rapidly dissolving patterns of the two lisinopril tablets that the two formulations were pharmaceutically equivalent. However, the in vivo bioequivalence study was required to fully evaluate the bioequivalence of the two drug products. In the in vivo bioequivalence study, the plasma samples drawn from the volunteers were analyzed utilizing a sensitive LC-MS-MS analysis method and the bioequivalence between the two drug products was assessed by statistical analysis of the log transformed mean ratios of Cmax,AUC(0-t) and AUC(0-infinity). The mean maximum concentration (Cmax) of the test and reference were found to be 60.41 +/- 20.07 ng/mL and 61.11 +/- 19.36 ng/mL, respectively. The 90% confidence intervals (C.I.) of Cmax were in the range from 0.91 to 1.08. As for the AUC(0-t) and the AUC(0-infinity), test values were 792.73 +/- 273.41 ng x mL(-1) x h, 862.74 +/- 303.81 ng x mL(-1) x h and the reference values were 841.66 +/- 286.07 ng . mL(-1) x h, 906.97 +/- 318.72 ng x mL(-1) x h, respectively. The 90% C. I. of AUC(0-t) were 0.86 to 1.01 and of AUC(0-infinity), 0.87 to 1.02 and thus were within the 80-125% interval proposed by the FDA. In addition to the 90% C.I. of the pharmaceutical parameters, a two-way ANOVA showed no significant difference between the two formulations. Based upon these statistical analyses, it was concluded that the test formulation is bioequivalent to the reference.

In vitro Dissolution and in vivo Bioequivalence Evaluation of Two Brands of Cefuroxime Axetil Tablets

The bioequivalence of two brands of 250 mg cefuroxime axetil (CAS 64544-07-6) tablets was evaluated by in vitro dissolution tests and in vivo bioequivalence tests. The in vitro dissolution test was performed by the paddle method following the guidance of the Korea Food and Drug Administration (KFDA). The in vivo bioequivalence study was designed to be a single dose, randomized, double-blind trial with a 1-week washout period between the doses in 26 healthy volunteers. The results of the dissolution test showed comparable and rapidly dissolving profiles of the two cefuroxime axetil tablets, which were pharmaceutically equivalent. The in vivo study was conducted to evaluate the bioequivalence of the two drug products in humans. In the in vivo bioequivalence study, the plasma samples drawn from the volunteers were analyzed utilizing a sensitive HPLC analysis method with ultraviolet detection. The evaluation of bioequivalence between test and reference products was accomplished by statistical analysis of the log transformed mean ratios of Cmax, AUC0–t and AUC0–8. The mean maximum concentration (Cmax) of the test and the reference were found to be 8.5 ± 2.0 µg/mL and 8.6 ± 2.1 µg/mL, respectively. The 90% C. I. of Cmax was 0.95 to 1.03. As for the AUC0–t and the AUC0–8, test values were 22.6 ± 5.7 µg mL−1 h, 23.5 ± 6.3 µg mL−1 h and the reference values were 25.6 ± 6.6 µg mL−1 h, 26.7 ± 6.8 µg mL−1 h, respectively. The 90% C. I. of AUC0–t was 0.83 to 0.94 and AUC0–8, 0.82 to 0.94. Consequently, all the results fulfilled the standard criteria of bioequivalence, being within the 0.80 to 1.25% range. In addition to the 90% C. I. of the parameters, a two-way ANOVA showed that there was no significant difference between the two products. Based on these statistical analyses, it is concluded that the test product is bioequivalent to the reference product.

Bioequivalence of Traline Tablet to Zoloft®Tablet (Sertraline HCI 50 mg)

Sertraline HCl, (1S-cis)-4-(3, 4-dichloro-phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-l-naphthalenamine hydro- chloride, is a potent and selective serotonin reuptake inhibitor which is used in the treatment of depression and obsessive- compulsive disorders. The purpose of the present study was to evaluate the bioequivalence of two sertraline HCl tablets, Traline tablet (Myungin Pharm. Co. Ltd.) and Zoloft ® tablet (Pfizer Inc.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of sertraline from the two sertraline HCl formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, 23.50± 1.74 years in age and 64.09±7.10 kg in body weight, were divided into two groups and a randomized 2 × 2 crossover study was employed. After a single tablet containing 50 mg as sertraline HCl was orally administered, blood samples were taken at predetermined time intervals and the concentrations of sertraline in serum were determined using an online column- switching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dis- solution media. The pharmacokinetic parameters such as AUCt, Cmax and Tmax were calculated, and computer programs (Equiv Test and K-BE Test) were utilized for the statistical analysis of the parameters using logarithmically transformed AUCt, Cmax and un-transformed Tmax. The results showed that the differences between two formulations based on the ref- erence drug, Zoloft ® tablet, were 0.04, 3.26 and -1.29% for AUCt, Cmax, and Tmax, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25. Thus, the criteria of the KFDA bioequivalence guideline were sat- isfied, indicating Traline tablet was bioequivalent to Zoloft ® tablet.

Rapid and Simple Method for the Determination of Pregabalin in Human Plasma using Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS): Application to a Bioequivalence Study of Daewoong Pregabalin Capsule To Lyrica®Capsule (Pregabalin 150 mg)

Method using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) was developed and validated for the determination of pregabalin in plasma samples. Acquisition was performed by monitoring the tran- sitions: m/z 160.1→142.2 for pregabalin and m/z 423.2→207.1 for losartan (as an internal standard). After cold acetonitrile- induced protein precipitation of the plasma samples, separation was performed with C18 column by isocratic mobile phase consisted of 10 mM ammonium acetate and acetonitrile (15:85, v/v). Results were linear over the concentration ranged from 0.1 to 10 µg/mL and the correlation coefficients (r) were ≥0.99. Intra- and inter-day precisions were ≤6.02 and ≤11.04%, respectively, and intra- and inter-day accuracies were 96.60-101.09 and 98.10-102.60%, respectively. This validated method was successfully applied to a bioequivalence study of two formulations of pregabalin, Daewoong pregabalin capsule (Dae- woong Pharm. Co., Ltd.) and Lyrica ® capsule (Pfizer Korea Ltd.) in twenty eight healthy Korean volunteers. The subjects received a single oral dose of each formulation (150 mg as pregabalin) in a randomized 2 × 2 crossover study and plasma samples were obtained from each subject at predetermined time intervals. Then, the pharmacokinetic parameters (AUC0-t, Cmax and Tmax) were calculated and statistically analyzed to assess the differences between two formulations. The 90% con- fidence intervals for the log-transformed data were acceptable range of log 0.8-log 1.25 (e.g., log 1.0048-log 1.0692 for AUC0-t, log 0.9142-log 1.0421 for Cmax). Thus, AUC0-t and Cmax met the criteria of the Korea Food and Drug Administration (KFDA) for bioequivalence test indicating that Daewoong pregabalin capsule was bioequivalent to Lyrica ® capsule.

Bioequivalence of Hana Loxoprofen Sodium Tablet to Dongwha Loxonin®Tablet (Loxoprofen Sodium 60 mg)

Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin(R) tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, 22.83±1.86 years in age and 69.92±9.14 kg in body weight, were divided into two groups and a randomized 2×2 crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as AUCt, Cmax and Tmax were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed AUCt, Cmax and un-transformed Tmax. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin(R) tablet, were 2.03, 2.99 and -9.49% for AUCt, Cmax, and Tmax, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for AUCt and Cmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin(R) tablet.

A study of consumers' perceptions and prediction of consumption patterns for generic health functional foods

The Korea Food and Drug Administration (KFDA) revised the Health Functional Food Act in 2008 and extended the form of health functional foods to general food types. Therefore, this study was performed to investigate consumers' perceptions of the expanded form of health functional food and to predict consumption patterns. For this study, 1,006 male and female adults aged 19 years and older were selected nationwide by multi-stage stratified random sampling and were surveyed in 1:1 interviews. The questionnaire survey was conducted by Korea Gallup. The subjects consisted of 497 (49.4%) males and 509 (50.6%) females. About 57.9% of the subjects recognized the KFDA's permission procedures for health functional foods. Regarding the health functional foods that the subjects had consumed, red ginseng products were the highest (45.3%), followed by nutritional supplements (34.9%), ginseng products (27.9%), lactobacillus-containing products (21.0%), aloe products (20.3%), and Japanese apricot extract products (18.4%). Opinions on expanding the form of health functional foods to general food types scored 4.7 points on a 7-point scale, showing positive responses. In terms of the effects of medicine-type health functional foods versus generic health functional foods, the highest response was 'same effects if the same ingredients are contained' at a rate of 34.7%. For intake frequency by food type, the response of 'daily consistent intake' was 31.7% for capsules, tablets, and pills, and 21.7% for extracts. For general food types, 'daily consistent intake' was 44.5% for rice and 22.8% for beverages, which were higher rates than those for medicine types. From the above results, consumers had positive opinions of the expansion of health functional foods to generic forms but are not expected to maintain accurate intake frequencies or amounts. Thus, continuous promotion and education are needed for proper intake of generic health functional foods.

Artificial Sweetener Intake of Korean Children is Insignificant

PP-30-127 Background/Aims: With a recent increase in intake of sweetened beverage among going school children, we attempted to assess dietary intake of artificial sweeteners (AS: aspartame, acesulfame-K, saccharin sodium). Because the previously estimated intake of AS among children was minimal, we focused on intake in consumer (C) group. Methods: A food frequency questionnaire was developed to estimate the intake of artificially sweetened beverages and snacks on the basis of the result of AS monitoring by Korea Food and Drug Administration (KFDA). In all, 28 schools each were selected for elementary, junior high, and high schools in Seoul, Korea, using a stratified multistage sampling method. Students in a class from second and fifth grades at elementary school, and second grade at junior high school and high school were surveyed for the frequency and amount of artificially sweetened beverages and snacks during 1 week before the survey. The survey was repeated for 3 seasons, from June through December 2009, to compensate for any possible seasonal effect. Sweetener intake was estimated by using AS database of KFDA and compared with the acceptable daily intake (ADI). Results: A total of 10,099 children responded to the survey. The mean AS intake of group C children was 0.25 ± 0.48 mg/kg bw/d, 0.18 ± 0.44 mg/kg bw/d, and 0.22 ± 0.25 mg/kg bw/d for aspartame, acesulfame-K, and saccharin sodium, respectively. Although these values were 1.5–5.5 times higher than those of all children, the corresponding values of ADI were only 0.63%, 1.23%, and 4.42% of respective ADI values set by JECFA. Even the 95th percentile values of ADI were far lower than the safety limit: 2.48%, 4.86%, and 15.59% for aspartame, acesulfame-K, and saccharin sodium, respectively. Conclusion: This study revealed that the AS intake through beverages and snacks among children in Korea is insignificant and very safe. This study was supported by R&D fund of KFDA (0808KFDA999-101).