• Communications for Statistical Applications and Methods
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• 제13권2호
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• pp.285-295
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• 2006

As more generic drugs become available, the quality, safety, and efficacy of generic drugs have become a public concern. Specifically, drug interchangeability among generic copies of the same brand-name drug is a safety concern. This research proposes a Bayesian method for assessing bioequivalence between two generic copies of the same brand-name drug from two independent $2{\times}2$ crossover design experiments. Uninformative priors are considered for general use and the posterior distribution of the difference of two generic drug effects is derived from which the highest probability density interval can be evaluated. Examples are presented for illustration.

• 한국의류학회지
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• 제23권7호
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• pp.953-964
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• 1999

The purpose of this study was to analyze the effectiveness of negative appeal ads taking social problems as their themes. Two social problem ad themes concerning abortion and drug addiction were selected as stimulus. Questionnaires consisted of questions about affective response cognitive evaluation consumer's characteristics(sex, clothing involvement social problem involvement) and the ad and brand attitudes They were distributed to 200 high school students in Seoul. Results were : 1 The affective response consisted of 4 dimensions(negative inactivating activating positive) and the cognitive evaluation had 3 dimensions(utility·persuasive power creativity awareness) 2. Creativity and awareness dimensions and the ad attitude had positive influence on the brand attitude for the abortion theme ad,. Creativity dimension and consumer's clothing involvement had positive influence on the brand attitude for the drug addiction theme ad . Especially the affective response had no significant influence on the brand attitude. This result suggests that in case of negative appeal ads the affective response does not necessarily degrade the brand attitude while positive cognitive evaluation on creativity and awareness of the could influence the brand attitude favorably through raising attention to the brand resulting in high effectiveness of the ad.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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• pp.91-92
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• 2003

Virtually every state in US has adopted laws and regulations that mandate the generic substitution of brand-named prescription drugs in order to reduce sky-rocketing drug costs. In the late 1970s, many state governments began to recognize the need of generic substitution and requested Food and Drug Administration (FDA) to consult with this issue. FDA did consult which drugs were interchangeable each other based upon the available scientific and experimental evidences given to the agency along with New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). (omitted)

• 약학회지
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• 제49권4호
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• pp.255-259
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• 2005

Financial standing of National Health Insurance has been experiencing a grave deterioration during the last 4-5 years, and the yearly amount paid by the insurance for drug expense rose up to 4 trillion won recently. Furthermore, the ratio of drug expenses in the total expenditure of the insurance reached about $25\%$, showing the tendency to be levelled off. As a measure to improve the financial deterioration of the insurance and to encourage generic substitution among the health professionals, we compared pharmacokinetic parameters of brand name drug (Lamisil) and generic drug (Muzonal) containing terbinafine HCl in healthy volunteers. The area under the curve (AUC) of the two drugs showed $2220.4\pm784.7\;and\;2143.1\pm861.6hr{\cdot}ng/ml$ in the corresponding order and no statistically significant difference was identified. The peak concentration $(C_{max})$ of the generic drug demonstrated $566.6\pm246.2 ng/ml$ compared to $550.8\pm204.0$ of brand name drug, which was not significantly different either. Time to reach peak concentration showed about 6 minutes difference between the drugs, which has no clinical significance to the treatment of dermatomycosis and dermatophytosis.

• 한국임상약학회지
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• 제27권2호
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• pp.105-112
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• 2017

Background: Generic medications are approved on the basis of bioequivalence with brand medications in healthy volunteers rather than the target population, there remains a substantial uncertainty regarding their clinical effectiveness and safety. The object of this paper is to compare the clinical equivalence of generic statin drugs in patients. Methods: Literature published before September 2016, which is indexed in PubMed, EMBASE, RISS, comparing generic to brand products in statins. Outcomes included blood lipid level, proportion of days covered (adherence), hospitalization and mortality. Results: 511 citations were screened, of which 11 studies met eligibility criteria (6 randomized clinical trials, 5 observational studies). Generic atorvastatin was clinical equivalent with brand drugs in blood lipid level (3 RCTs) and generic simvastatin was also clinical equivalent with brand drugs (2 RCTs). 2 of 3 studies reported no significant difference in proportion of days covered except 1 study which reported generic statin significantly enhance proportion of days covered (p<0.001). Hospitalization was no significant difference in all studies (p>0.05). 1 study reported that all cause of mortality was significantly low in generic drugs (p<0.0001). Conclusion: Published data on comparing clinical efficacy of generic and brand statins were insufficient in both quantity and quality. This systematic review suggests that additional studies on clinical equivalence and safety of generic medications in patients would be needed.

• 응용통계연구
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• 제24권3호
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• pp.495-503
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• 2011

When a patent of an innovative (brand-name) small-molecule drug expires, generic copies of the innovative drug may be marketed if their therapeutic equivalence to the innovative drug has been shown. The small-molecule drugs are considered therapeutically equivalent and can be used interchangeably if two drugs are shown to be pharmaceutically equivalent with identical active substance and bioequivalent with comparable pharmacokinetics in a crossover clinical trial. However, the therapeutic equivalence paradigm cannot be applied to biosimilars since the active ingredients of biosimilars are huge molecules with complex and heterogeneous structures, and these molecules are difficult to replicate in every detail. The European Medicine Agency(EMEA) has introduced a regulatory biosimilar pathway which mandates clinical trials to show therapeutic equivalence. In this paper, we discuss statistical considerations in the design and analysis of biosimilar cancer clinical trials.

• 한국임상약학회지
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• 제16권2호
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• pp.96-100
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• 2006

Korea Food and Drug Administration (KFDA) has been expediting the Biological Equivalence Examination (BEE) project to encourage generic substitution without expense of inappropriate therapeutic outcome. However, little is known about which considerations are most important in making the decision to prescribe a drug among many generic drugs. The purpose of this survey was to identify how strongly the KFDA certification of BEE influenced doctors when they make a choice between brand and generics of glimepiride preparations. Telephone survey was performed towards doctors working at local clinics by using a questionnaire. Most influential factor to doctors' decision was drug cost followed by pharmaceutical representatives, therapeutic efficacy, and review guideline for reimbursement. Advertisement of the drug was the least influential followed by KFDA certification of BEE. The meaning of BEE was best understood by relatively young doctors with specialty in surgical parts. This survey result further indicated that the doctors considered the therapeutic equivalence examination a preferred measure to expedite generic substitution.

• 한국임상약학회지
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• 제26권2호
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• pp.121-127
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• 2016

Objective: Until now, there is minimal number of research for overall domestic status of orphan drug use in Korea. The purpose of this study is to identify the list of orphan drugs available in Korea and to understand the status of orphan drug usage in tertiary Hospitals and rare incurable disease Hospital. Methods: We made domestic orphan drug lists based on available orphan drugs in Korea. Based on this lists, we conducted e-mail survey from August, 2014 to September, 2014 to identify domestic status of orphan drug usage including the availability and management of orphan drugs. Results: There are three hundred and eighteen orphan drugs (184 ingredients) registered in Ministry of Food and Drug Safety. Among the three hundred and eighteen orphan drugs, Two hundred and twenty-eight drugs (102 ingredients) were selected. Information on each item was collected and documented with generic and brand names, manufacturers, wholesalers, indications, FDA approval status and insurance coverage. Forty-three tertiary hospitals and thirty-two rare incurable hospitals responded to the survey questionnaire (57.3%). According to the survey result, the antineoplastics and immunomodulating agents group has the highest percentage (40%) usage in the hospital. Of fortythree tertiary hospitals, thirteen hospitals manage orphan drugs separately (30.2%). Based on the reply, most of the healthcare professionals commented the drug information related to efficacy and safety including medication counseling of orphan drugs is insufficient. Conclusion: Through this study we anticipate providing an understanding of orphan drug usage status in Korea. We found the limited resources to the information on orphan drugs and this information requires updating on a regular basis. This can be the basis for further studies about preparing drug information, educational resources for rare disease patients.

• Journal of Pharmaceutical Investigation
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• 제19권2호
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• pp.93-98
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• 1989

The study was performed to compare the dissolution, diffusion and absorption characteristics using Sartorius dissolution and absorption simulator and in vivo bioavailability of commercially available rifampicin capsules. Both brands C and F showed similar dissolution patterns and absorption properties through artificial gastric barrier in Sartorius simulator. Diffusion rate constants through the membrane of brands C and F were $3.04\;{\times}40^{-3}$ and $2.88\;{\times}\;10^{-3}cm/min$, respectively. Rifampicin capsules were administered orally to six fasted healthy volunteers according to cross-over design. The pharmacokinetic parameters between brands C and F, maximum plasma drug concentration$(C_{max})$, the time to reach $C_{max}$, absorption rate constant and area under the curve $(AUC_{0-24hr})$, elimination rate constant, and amount of drug excreted in urine were 6.11 and $7.27\;{\mu}g/ml$, 2.71 and 1.52 hr, 0.6371 and $1.6456 hr^{-1}$, 57.84 and $57.28\;{\mu}g\;{\cdot}\;hr/ml$, 0.1891 and $0.1734 hr^{-l}$, 119.98 and 119.93 mg, respectively. On the basis of experimental results, it was concluded that the bioavailability of brand C rifampicin capsules was almost the same as that of brand F rifampicin capsules.

• 한국임상약학회지
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• 제30권4호
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• pp.226-233
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• 2020

Background: Currently, the over-the-counter (OTC) drug market is flooded with series OTC products. The pharmacist must follow the OTC product's indication, given that the most critical role of a pharmacist is the right selection and recommendation of an OTC drug for a patient's symptoms in a dynamic pharmacy environment. Therefore, pharmacists must know each OTC product information precisely to avoid any ambiguity due to several OTC series brand names. Objective: We evaluated the risk and effectiveness of OTC series medicines. Methods: From December 5 to December 18, 2019, an online survey was conducted among 145 community pharmacists. Results: A total of 51.0% of pharmacists knew the difference between products named in a series and could explain it spontaneously. Only 0.7% of the pharmacists admitted to not knowing the difference between products named in a series. While 42.9% of pharmacists who owned a pharmacy opined that the OTC medicines named in a series have health benefits for patients, 50.0% of employee pharmacists admitted that they were rather confused because there are several OTC series medicines. In contrast, 69.2% of pharmacists who owned pharmacies and 72.2% of employee pharmacists admitted that OTC series drugs with names similar to popular OTC drugs sell better. Conclusion: While pharmacists had different opinions regarding OTC series drugs per employment status, they opined that OTC series are more helpful in pharmacy management than completely new brand names. Further studies in this regard are needed.