• Proceedings of the Korean Society of Toxicology Conference
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• 2006.11a
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• pp.80-86
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• 2006

Bioequivalence is a term in pharmacokinetics used to access the expected in vivo biological equivalence of two proprietary preparations of a drug. Bioequivalence studies are usually performed for generic drugs. Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilioes after administration in the same molar dose are similar. Bioequivalence is usually accessed by single dose in vivo studies in healthy volunteers and the reference product is usually the innovator product that is marketed. Regulatory definition of bioequivalence is based on the statistical analysis of thebioavailability of the reference and test product. In general, two products are evaluated as bioequivalent if the 90% confidence interval of the relative mean Cmaxand AUC of the test to reference product are within 80.00% to 125.00% in the fasting state. Key process in bioequivalence study is development and validation of bioanalytical method, determination of the drug concentration in the biosamples (usually plasma or serum) obtained from volunteers, calculation of the pharmacokinetic parameters and statistical analysis of the pharmacokinetic parameters. Although current guidelines and regulations do not require the bioequivalence studies to be done under good laboratory practice (CLP), the issues to perform the bioequivalence studies under GLP environment is emerged both from the regulatory and industry side. GLP perspectives of bioequivalence studiesare needed to be discussed in respect to achieve quality assurance in bioequivalence studies.

• Analytical Science and Technology
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• v.29 no.6
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• pp.255-260
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• 2016

Based on the Korean Health Functional Food Act, health functional foods are dietary supplements containing nutrients or other substances that have nutritional or physiological effects. Since generic health functional food items have been expanded, this project was performed to develop a standardized analytical method of examining such sale items. The method exhibited high linearity in the quercetin calibration curve ($R^2$ > 0.999) over concentrations of $0-40{\mu}g/mL$. The limits of detection and quantitation for quercetin were $0.12{\mu}g/mL$ and $0.36{\mu}g/mL$, respectively, while quercetin recovery was 97.1-105.4 % with standard deviations of 1.15-3.11 %. To verify the accuracy of the analytical methods, the labeled amounts of purchased health functional foods were monitored. The recovery rate for multiple quercetin concentrations ranged from 82.5-105.1 % of the labeled amounts. Thus, the new method was suitable for all cases.

• Natural Product Sciences
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• v.25 no.4
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• pp.293-297
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• 2019

Policosanol extracted from sugarcane wax is a generic term used for total fatty alcohols obtained from esterification of fatty acids. It has been approved as a health functional food by the Ministry of Food and Drug Safety of Korea in 2006. Policosanol is well-known to aid in lowering blood cholesterol level. Recently, several studies have reported the physiological activities of policosanol, such as anti-inflammatory effects, antioxidant effects, and lowering of the incidence of ageing-related diseases, for example, hypertension, stroke, among others. This review describes the physiological activities of policosanol and its applications in the field of health functional foods.

• Proceedings of the PSK Conference
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• 2003.04a
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• pp.315.1-315.1
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• 2003

After beginning the new medical system separating the prescription from the drug dispensary, the demand of bioequivalence test significantly increases to show the equivalence between the test and reference drugs as a result of amendment of the pharmaceutical affairs law which allows a generic substitution. Accordingly the standard protocols provided by the government are required for reducing the period andthe cost to perform the bioequivalence study. (omitted)

• Journal of Food Hygiene and Safety
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• v.33 no.1
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• pp.44-49
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• 2018

As generic health functional food items have been expanded, this research project has been conducted to prepare a scientific and systematic standardized analytical method of relevant food item and examine the suitability of the method for health/functional foods on sale. Total polyphenol was necessary for development and verification of standardized analytical method. The method exhibited high linearity in the tannic acid calibration curve ($r^2$ > 0.999) over concentrations of $5-50{\mu}g/mL$. The limits of detection and quantitation for tannic acid were $5{\mu}g/mL$ and $15{\mu}g/mL$, respectively, while tannic acid recovery was 102.3-112.4% with standard deviations of 0.8-3.2%. To verify the accuracy of the analytical method, the labeled amounts of purchased health functional foods were monitored. The recovery for tannic acid was 105.6% of the labeled amounts. Thus, the new method was suitable for all cases.

• Korean Journal of Clinical Pharmacy
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• v.9 no.2
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• pp.109-118
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• 1999

The need for and components of a contemporary community pharmacy externship for pharmacy students have not been clearly identified in Korea. Mail survey was performed among 20 college of pharmacy deans and 800 community pharmacists to analyze the current status and develop a consensus regarding major focus area and criteria of community pharmacy externship to be implemented under the separation of dispensary from medical practice in year 2000. Mail survey yielded $80\%\;and\;23.5\%$ response rate for pharmacy school deans and community pharmacists, respectively. Of the 16 pharmacy schools that responded 14 said they have externship program in hospital pharmacy, and only 8 pharmacy schools responded of having externship program for community pharmacy. However, these community pharmacy programs lacked criteria and standard guideline for the externship. The results of survey revealed that community pharmacy externship program for students should be organized and directed toward developing expert knowledge and skills in pharmacy practice activities, clinical services, communications, pharmacy management, and professionalism. Pharmacy practice components should include competencies and skills in computer application, prescription processing, dispensing, pharmaceutical compounding, Narcotics Control Law application, maintenance and provision of drug information, and laws and regulations. Clinical service components should include the ability to identify patient's drug-related problems, provide long-term patient care and appreciate drug therapy services. Communication skills should be taught to effectively express his/her professional opinion, deduce the needs of others, utilize appropriate techniques and media to communicate ideas and conduct a patient interview and to obtain patient drug history. Pharmacy management skills should be taught to be efficient in medical insurance and drug control process. It was found that professionalism, morality, pharmacy practice experience, ability to provide clinical services, collect and provide drug information and regality are important criteria of preceptors. Externship sites should possess the ability to stock various drugs, access and provide diverse pharmacy services and should have private patient counseling area. Most pharmacists agreed that top 200 drugs' generic and brand name, indications, dosage, side effects, and contraindication should be instructed during the externship. It was also found that student and preceptor should be evaluated for their performances during the externship. This information will be incorporated into teaming objectives for students and to develop Academic Extemship Program Guidelines.

• YAKHAK HOEJI
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• v.56 no.5
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• pp.288-292
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• 2012

The aim of the paper is to ameliorate old research methods of Korean Pharmaceutical Codex to adjust the newest scientistic level which is necessary to maintain quality of medical supplies effectively. After reviewing result of Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph, there are two items chosen for the methods - Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph which KFDA researched in 2010, arranged new measuring standard by having an experiment to set measuring method after obtaining each item. According to the result, The experiment includes a measuring method of two items; Nafronyl Oxalate Capsules, and Ticlopidine Hydrochloride Tablets. The research is ameliorated by research methods through several experiments such as High Performance Liquid Chromatography validation, preparing items, implement of trial-experiment and authentic experiment, and experiment on measuring method of regulations of Korea Pharmaceutical Codex. The experiments are taken opinions of experts in KFDA into consideration and wrote out a report of the new measuring method on each last item. The report is combined as each two experiment sections of analyzing method to maintain the quality on the basis of the research in 2010 on setting of dissolution specifications for oral solid dosage forms. The result of measuring method of medical supplies through modernizing trial method of oral solid dosage forms is available to be accurate. In conclusion, this study could contribute to promotion of public health by organizing a basis for safe and high quality of medical supplies in domestic market.

• Korean Journal of Clinical Pharmacy
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• v.7 no.1
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• pp.17-21
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• 1997

Cefaclor is a second generation cephalosporin antibiotic that shows a potent antibacterial activity against both Gram-positive and Gram-negative bacteria, when it is orally administered. Due to its patent expiration, a number of generic drugs have been marketed, but not yet elucidated to ensure therapeutic equivalence. In this study, cefaclor capsules manufactured by Chong Kun Dang were bioequivallently assessed by comparing with $Ceclor^{TM}$ introduced originally by Daewoong Lilly. A total of 16 healthy male volunteers were evaluated in a randomized crossover manner with a 2-week washout period. Concentrations of cefaclor in plasma were measured upto 6 hours following a single oral administration of two capsules (500 mg of cefaclor) by high-performance liquid chromatography with UV detection. Although the plasma concentration at 6 hours was not detected, the computed half-life of cefaclor was approximately 0.5 hours. The area under the concentration-vs-time curve from 0 to 4 hours $(AUC_{0-4h})$ was calculated by the trapezoidal summation method. The differences in mean values of $AUC_{0-4h}$, peak plasma concentration $(C_{max})$, and time to peak concentration $(T_{max})$ between the two products were $4.63\%,\;1.84\%,\;and\3.28\%$, respectively. The least significant differences at $\alpha4= 0.05 for $AUC_{0-4h},\;C_{max},\;and\;T_{max}\;were\;6,53\%,\;4.05\%,\;and\;6.47\%$, respectively. In conclusion, the test drug was bioequivalent with the reference drug.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.11
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• pp.4951-4957
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• 2016

Background: Apart from reducing occupational exposure to cytotoxic hazards, the PhaSeal(R) closed-system transfer device (CSTD) can extend the beyond-use dates (BUDs) of unfinished vials of antineoplastic drugs for up to 168 hours (seven days). In this study, the total material cost incurred by its use in a Malaysian government-funded hospital was calculated. Methods: A list of vial stability following initial needle punctures of 29 commonly-used antineoplastic drugs was compiled. The amount of the materials used, including drugs, infusion bottles, the PhaSeal(R) CSTD and other consumables, was recorded on a daily basis for three months in 2015. The total cost was calculated based on the actual acquisition costs, and was compared with that of a hypothetical scenario, whereby conventional syringe-needle sets were used for the same amounts of preparations. Results: The use of the PhaSeal(R) CSTD incurred a cost of MYR 383,634.52 (USD 92,072.28) in three months, representing an average of MYR 170.5 (USD 40.92) per preparation or an estimated annual cost of MYR 1,534,538.08 (USD 368,289.14). Compared with conventional syringe-needle approach, it is estimated to lead to an additional spending of MYR 148,627.68 (USD 35,670.64) yearly. Conclusion: Although there was a reduction of drug wastage achieved by extending BUDs of unfinished vials using the PhaSeal(R) CSTD, cost saving was not observed, likely attributable to the wide use of lower-priced generic drugs in Malaysia. Future studies should further evaluate the possibility of cost saving, especially in health settings where branded and high-cost antineoplastic drugs are more commonly used.

• The Korean Journal of Applied Statistics
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• v.18 no.1
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• pp.159-171
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• 2005

The US Food and Drug Administration(FDA) recommends that population bioequivalence and individual bioequivalence would be assessed to address the prescribability and switchability between a brand-name drug and its new formulation or generic copy in its 2001 guidance document. The test for population bioequivalence in the latest FDA guidance is recommended in 2 x 4 crossover design, but it turns out to be very conservative. Recently Lee, Shao & Chow(2002), Chow, Shao & Wang(2003) and McNally, Iyer & Mathew(2002) proposed new statistical methods for assessing population bioequivalence between drugs to correct the biasness of current FDA method. Since 2 x 2 crossover experiment is most welcomed design in bioequivalence testing, we adopt their methods to 2 x 2 crossover designs and compare their methodologies with FDA one through the simulation study.