• Journal of Korean Society for Quality Management
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• v.22 no.4
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• pp.102-110
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• 1994

We investigate the small-sample behavior of the probability of rejection curves and its performance for a equivalence testing procedure based on confidence intervals which was developed with a motivation from bioequivalence studies. This type of equivalence studies are conducted frequently in pharmaceutical industries to compare the relative bioavailabilty of two formulations of a drug and can be applied various fields where assurance of quality equivalence is needed. From the Monte-Carlo simulation results we suggest proper sample sizes for the equivalence testing procedure.

• Proceedings of the PSK Conference
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• 2005.04a
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• pp.147-147
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• 2005

• Herbal Formula Science
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• v.24 no.2
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• pp.71-79
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• 2016

Objectives : To verify the equivalence between Atractylodis Rhizoma Alba herbal prescription(HP-ARA) and Atractylodis Rhizoma Alba herbal sub stance(HS-ARA). Methods : Safety tests by microbial regulation and heavy metal analysis (total heavy metal, Pb, As) and a stability test by long term shelf test for HP-ARA according to notification of the Ministry of Food and Drug Safety were carried out. Then, multi component profile of HP-ARA and HS -ARA were analyzed by HPLC. Results : The safety and stability of HP-ARA confirmed by several tests. Correlation coefficient of equivalence of HP-ARA and ARA-HS showed 0.992. Conclusion : Based on this result of equivalence between HP-ARA and HS-ARA, HP-ARA can substitute HS-ARA used to make herbal medicines (herbal decoction, pills and powder).

• Proceedings of the PSK Conference
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• 2005.11a
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• pp.113-113
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• 2005

• 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 Korean Society for Quality Management
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• v.50 no.4
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• pp.831-842
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• 2022

Purpose: This study carried out the Quality by Design (QbD)6σ process to verify the effectiveness and equivalence of the finished D-antigen quantitative test method, and compared the OFAT-based method validation and test result acceptance criteria with the Analytical Quality by Design (AQbD)-based method validation and test method. This is a study on how to reduce the risk of delay in permit change by increasing the reliability of permit data in the existing method by statistically analyzing the results. Methods: With the QbD6σ process, the effectiveness and equivalence of the D-antigen quantitative test method were verified with the data of the existing test method and the new test method. Results: Method validation tests are performed based on AQbD. Critical Method Parameters are identified through risk assessment, and single/combined actions are verified by designing and performing tests for Critical Method Parameters (analysis of variance, full factorial design method). Method validation can be effectively accomplished with the QbD6σ process. Conclusion: The use of QbD6σ can be used to achieve satisfactory results for both pharmaceutical companies and regulators by using appropriate statistical analytical methods for method validation as required by regulatory agencies.

• The Korean Journal of Applied Statistics
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• v.21 no.5
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• pp.867-873
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• 2008

It is a convention to use 5% significance level when a statistical test is employed for clinical data. But when a confidence interval is used for testing equivalence, 90% confidence interval has often been used. When $1-{\alpha}$ confidence interval is used for hypothesis testing, its significance level is often ${\alpha}$. So it makes a confusion that the significance level is 10% if 90% confidence interval is employed for testing equivalence. In this paper I will clarify this issue by reviewing relevant papers and conducting simulation studies. I hope that it will be beneficial to statisticians in pharmaceutical companies, CROs, university hospitals.

• YAKHAK HOEJI
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• v.39 no.2
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• pp.205-209
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• 1995

Methylene protons of benzyl and ethyl ester in ethyl 1-benzyl-2, 3-dioxo-cyclopenta[b]-pyrrole-3a-carboxylate (A) exhibited opposite$^{1}$H-NMR spectral patterns mutually between magnetic equivalence and nonequivalence depending on concentration and temperature. The diastereotopic spectral data of compound A were reported with brief interpretation.

• 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 Pharmaceutical Investigation
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• v.35 no.3
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• pp.157-163
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• 2005

The pellets with multiple drug release system (MDRS) of Diltiazem. HCl which consist of immediate drug release layer, drug reservoir layer and controlled release rate membrane, were prepared by using CF-Coater. As main factors for more effective MDRS of Diltiazem. HCl, ethylcellulose was used for the controlling drug release rate, and diethylphthalate was used for plasticizer, respectively. In vitro evaluation study was performed by comparative dissolution test between our test MDRS and reference Diltiazem. HCl preparation. The physical tests were performed using FT-IR and SEM. In vivo evaluation was also performed by observing the behavior of a plasma drug concentration after oral administration. The bioavailability was determined by analyzing the blood sample after oral administration to healthy, male volunteers once a day. As a result, there were no significant differences in bioequivalence parameters $(AUC_{\infty},\;C_{max},\;t_{1/2})$ between two systems. It might be concluded that our MDRS of Diltiazem. HCl could be an alternative delivery system to reference drug preparation.