• The Korean Journal of Applied Statistics
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• v.24 no.3
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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.

• 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.

• 한국임상약학회:학술대회논문집
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• 2007.12a
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• pp.170-170
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• 2007

• 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.

• Korean Journal of Clinical Pharmacy
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• v.16 no.2
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• pp.139-146
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• 2006

Objectives: Bio-equivalence(BE) test is important not only to ensure the quality of generic drugs, but also to promote drug substitution under the separation of prescribing and dispensing practice(SPD). This study was intended to investigate the perception of consumers, doctors, and pharmacists on the confidence of bio-equivalence(BE) assured drugs. Methods: Nation-wide telephone interview survey was conducted for 1,018 consumers, 800 doctors, and 806 pharmacists from September to October in 2003. Descriptive analysis and ${\chi}^2$ analysis were conducted. Results: Even though people showed higher confidence level for the Bioequivalent drugs compared with Bio-inequivalent drugs, the confidence was generally low. Among those asked about the therapeutic substitutability of original drugs by BE versions, 95.78% of pharmacists responded "positive", while only 39.33% of consumers and 31.13% of doctors said so. The elderly, the less educated, who takes chronic disease medicine, pays high cost of prescription drugs, and are in the low income responded less aware of that. Also most consumers got information such as effect of drugs from either media or doctors. Conclusions: In order for people to believe that BE drugs and original drugs are equivalent, we need to strengthen health education, and to clarify any misunderstanding. It is also necessary for the national policy to provide accurate information about drugs to the public.

• Therapeutic Science for Rehabilitation
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• v.9 no.1
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• pp.56-68
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• 2020

Objective : This study introduces domestic and overseas systematic assessment tools that can identify eating problems of dementia patients based on abnormal behavior observations and turns them into Korean through the verification of content placement by expert groups. Methods : Three types of assessment tools were selected for final development in Korean version through several meetings based on a wide range of relevant literature searches. The 3 selected assessment tools were first translated by the researchers, and a 9-person expert team was used to verify the Content Validity Index. Results : The EBS content equivalence calculation shows that all 6 questions and 1 response item had a CVI value 0.9, and all items were included in Korean EBS without modification. The EdFED content equivalence calculation showed that all 11 questions had CVI value 0.9, which was included in the Korean edition of EdFED without modification. The content equivalence calculation of the FDI showed that all 19 questions had a CVI of 0.8 or higher, and all items were included in the Korean version of the FDI without modification of the item. Conclusion : Korean versions of the EBS, EdFED and FDI, which are based on behavioral observation and diet tools for people with dementia, have been developed. Early determination of problems related to diet in dementia patients and providing proper intervention through observational Korean version assessment tools is vital in terms of strengthening patient nutrition and reducing caregivers' burden.

• Archives of Pharmacal Research
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• v.13 no.2
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• pp.180-186
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• 1990

A bioequivalence study of ranitidine tablets was conducted according to the Korean Guidine for the Bioequivalence Test using twelve healthy male subjects. The plasma concentration-timecurves of ranitidine from the test and reference tablets showed profound multiple peak phenomenon in each subject as reported earlier. However, the area under the plasma concentration-time curve (AUC) and the maximum ploasma concentration at the first peak ($C_{max1}$) of the two preparations was proven to be equal when analyzed satistically according to the criteria of the guidline;i. e., statistical power (1-$\beta$)was calculated to be over 0.8 under the condition of $\alpha$ = 5% and $\Delta$(minimum detectable difference) = 20%, and the confidence interval of the difference in AUC at 95% confidence level was in the range of $\pm$ 20%, which statisfied the criteria of bioequivalence. Equivalence of the peak concentration of ranitidine at the second peak ($C_{max2}$), and the time to reach the first ($T_{max1}$) and second verify the bioequivalence of $c_{max2}$ , $T_{max1}$ and $T_{max2}$ between the two tablets. However, we conclude that the test and reference tablets are bioequivalent taking the therapeutic characteristics of the ranitidine preparations into consideration.

• Therapeutic Science for Rehabilitation
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• v.8 no.4
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• pp.77-92
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• 2019

Objective : This study aims to obtain the validation of Korean version of HOME FAST using the translation-back translation process and to evaluate the reliability. Methods : Total three stages were conducted which includes forward translation to Korean, test for degree of understanding of translated version, back translation to English, and then review and proof reading process. 21 occupational therapists were participated in the evaluation of understanding of Korean-translated HOME FAST, then some of expressions were modified for better understanding. Korean version was went through back-translation to English. Similarity between the original version and re-translated version were evaluated. Total 75 data from community dwelling elderly group were collected to assess internal consistency. Two occupational therapists simultaneously evaluated for the inter-rater reliability. Results : 11 items of Korean-translated scale were responded as having confused meaning by occupational therapists. There was some modification on expression. In the evaluation of similarity between original version and re-translated version, 3 items were selected as dissimilar items in terms of syntax and 6 items were selected in terms of semantic similarity. After the repetitive modification process, items were obtained conceptual equivalence between two different languages. Internal consistency was .62(KR20) (p<.01) and inter-rater reliability was .97(ICC) (p<.01). Conclusion : Korean version of HOME FAST was finalized through translation-retranslation process. The conceptual equivalence was established and Korean version showed highly reliable. In further study, The modification of items reflecting Korean house and life style should be conducted.

• The Journal of the Acoustical Society of Korea
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• v.42 no.5
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• pp.469-490
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• 2023

Survey was carried out on the acoustic outputs from 12 shock wave fields produced by the 10 extracorporeal shock wave lithotriptors whose technical documents are available, among the 33 devices approved by the Ministry of Food & Drug Safety (MFDS).The results show that the acoustic outputs (P+, P-, efd, and E), critical to the therapeutic efficacy and the patient safety, are largely different between the devices. The maximum values of P+, P-, efd, and E vary up to 2.08, 3.72, 3.89, and 15.98 times, respectively. The acoustic output parameters are not thoroughly provided in the technical documents, and some of data (eg. efd) are suspected to be abnormal outside usual ranges. The large device to device differences in the shock wave outputs are likely to undermine equivalence between the ESWL devices approved for the same indication. To verify the reliability of the data in the technical documents of the approved devices and to confirm if the acoustic outputs from the devices in clinical use are the same as those in their technical documents, an authorized test laboratory should be available. A postapproval monitoring led by the regulatory agency is suggested to maintain the acoustic outputs from the ESWL devices that suffer from degrading in performance due to aging.

• 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.