• Communications for Statistical Applications and Methods
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• v.13 no.2
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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.

• Proceedings of the PSK Conference
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• 2003.04a
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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)

• Journal of Pharmaceutical Investigation
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• v.34 no.4
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• pp.333-340
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• 2004

A new medical system of separation of dispensary from medical practice was started in 2000 in Korea. To expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are hot issues in Korea. The KFDA also has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drugs should be submitted to the KFDA in the application for drug approval. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. In this paper, we examined the recently published Japanese guideline, Guideline for Bioequivalence Studies of Generic Products For Topical Uses, and Q&A of the guideline, which will be references to make a guidance on bioequivalence studies of topical drug products in Korea.

• Proceedings of the PSK Conference
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• 2003.10a
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• pp.42-42
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• 2003

Recently, Korean Food and Drug Administration (KFDA) has been attempting to modernize the review processes for generic drug products. Obviously, the modernization effort will lead to harmonize the guidelines in the process to the internationally acceptable level. In general, the Korean version of abbreviated new drug application (ANDA) consisted of similarly to those in developed countries (viz, specifications for bulk drug/preparation, bioequivalence, and stability); However, there exists a significant gap in the sophistication of the guidelines between the Korean version and those in the other countries. (omitted)

• YAKHAK HOEJI
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• v.49 no.4
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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.

• Korean Journal of Clinical Pharmacy
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• v.15 no.2
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• pp.82-88
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• 2005

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies.

• Health Policy and Management
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• v.23 no.3
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• pp.210-223
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• 2013

Backgrounds: Escalating pharmaceutical expenditure has threatened the sustainability of National Health Insurance system in Korea. Generic medicines allow patients to access safe, effective, high-quality medicines at low cost, thus insurers could achieve significant financial savings by promotion of generics, if they are priced much lower than the originator. The purpose of this study was to review generic pricing as well as promotion policies in other countries and assess the implication of those policies. Methods: We reviewed the main measures adopted by the developed countries such as Austria, Belgium, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Sweden, United Kingdom, especially in countries where governments are the largest third-party payers or insurance finance resource is the national health insurance. Results: The foreign countries's experience with generic medicine policy shows that demand-side policies such as physician budgets, international nonproprietary name prescribing, generics substitution, patients co-payment as well as supply-side policies relating to pricing and reimbursement seems to play a critical role in developing the generic medicines market. Conclusion: Various strategy should be implemented to promote generic drug use.

• Korean Journal of Clinical Pharmacy
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• v.24 no.2
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• pp.126-134
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• 2014

Purpose: This study was aimed to examine the financial effect of 2-tiered copayment system on annual expenditure of pharmacy benefit in the National Health Insurance (NHI) of Korea, focusing on oral antidiabetic medications. Methods: 284 oral antidiabetic products with 14 different active single ingredients listed in the National Formulary of NHI (August 2009) were assigned to tier 1 or tier 2 according to the selected criteria. 10 different combinations of coinsurance rates were selected to estimate the changes in drug expenditure cost of NHI. Results: The annual drug cost was estimated based on the drug price per unit listed in the National Formulary and the used amount of products in 2009 from the IMS Health data of Korea. In the combinations of coinsurance rate of 20% for tier 1 and 40% for tier 2, the total annual drug cost was estimated to be reduced by 1.3% in the case of no change of generic and original drug consumptions, and to be reduced by 4.3% in the case of 10% increased generic drug consumptions. Conclusion: The tiered copayment system with optimal coinsurance rates appears to be a potential strategy to reduce the financial burden of NHI in Korea by promoting the use of generic products.

• Korean Journal of Clinical Pharmacy
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• v.16 no.2
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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.

• Journal of Pharmaceutical Investigation
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• v.34 no.3
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• pp.223-228
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• 2004

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to the drug products which are proven to be bioequivalent to the reference listed drugs. To expand the list of bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are the hot issues in Korea. Also, the KFDA has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drug products should be submitted to the KFDA for drug approval after July in 2004. Therefore, it is increasing the necessity to develop the bioequivalence-demonstrating methods for specific drug substances and preparations which require to conduct food-effect bioavailability or bioequivalence study. There are some differences between US and Japanese guidances of food-effect bioavailability and bioequivalence studies. In this paper, we examined the recently published US guidance about food-effect study and it will be a reference to make our own guidance about food-effect bioavailability and bioequivalence guidances in Korea.