No abstract available.
Blood Donors* ; Female ; Humans ; Pregnancy ; Pregnancy Trimester, Third* ; Pregnancy*

The equivalence margin is the largest difference that is clinically acceptable between the test (or experimental) drug and the active control (or reference) drug. This paper discusses the scientific principles, along with the regulatory issues, that need to be addressed when determining the equivalence margin for the biosimilar product. The concept of assay sensitivity is introduced, and the ways to ensure assay sensitivity in the equivalence trial are emphasized. A hypothetical example is presented to show how an equivalence margin is determined. The regulatory agency should carefully assess if the equivalence margin of the biosimilar product was determined using a scientifically valid and clinically relevant approach, not subject to selection bias. This is important because the consumer risk of erroneously declaring equivalence when in fact it is not must be controlled conservatively low in the approval of any biosimilar products.
Dietary Sucrose ; Selection Bias

Forty-one Korean immigrants in Washington, D.C. (of the United States) metropolitan area over age 60 were interviewed using the Diagnostic Interview Schedule (Korean version) with additional questions about culture-specific somatic symptoms identified in previous research with Korean populations. The lifetime and current prevalence were 29.27 percent and 14.63 percent, respectively, for major depression; 9.76 percent and 2.44 percent for generalized anxiety disorder; and 9.76 percent and 7.32 percent for somatization disorder. The lifetime and current rates of co-occurrence of major depression and somatization disorder were 25 percent and 33.33 percent. Subjects who met criteria for depression were more likely to experience culture-specific Korean somatic symptoms than subjects who did not meet those criteria.
Aged ; Aged, 80 and over ; Depression/*epidemiology ; District of Columbia/epidemiology ; *Emigration and Immigration ; Female ; Human ; Korea/ethnology ; Male ; Middle Age ; Prevalence ; Psychophysiologic Disorders/*epidemiology

Sinking skin flap syndrome is defined by a series of neurological symptoms with skin depression at the site of cranial defect. We experienced neurological improvement in a patient with markedly sunken craniectomy site after ventriculoperitoneal shunt (V-P shunt) clamping operation. A 17-year old female patient was in vegetative state and spastic quadriplegia after traumatic brain injury. She was suffered from frequent vomiting. To evaluate central nervous system problem we checked brain computed tomography which showed that right frontotemporoparietal craniectomy area was markedly sunken and midline was shifting to the left. After V-P shunt clamping operation, craniectomy site was elevated and midline shifting was improved. Vomiting was disappeared. Coma Recovery Scale-revised (CRS-R) score was improved from 3 to 6.

The ‘equivalent-or-more-but-not-the-same-data’ provision in the Regulation on the Safety and Efficacy Evaluation of New Drug in Korea has served as the de facto data exclusivity term for any drug identical to a product subject to new drug reexamination. The legal debate that occurred between Abbott Korea and Hanmi in association with the approval of their sibutramine products, i.e., Reductil® vs. Slimmer®, showed why data exclusivity plays an important role to protect intellectual property of the innovator drug when incrementally modified drugs had to rely on the safety and efficacy data of the innovator drug for approval. The regulatory science and legal issues regarding the case of Reductil® vs Slimmer® were discussed, and the importance of data exclusivity was emphasized as a useful tool to protect intellectual property besides patent.
Intellectual Property ; Korea ; Mesylates

Objective: This study aimed to overview and assess the effectiveness of the policies and regulations that have governed new drug access in Korea, and to propose policies to enhance patient access to drugs, particularly for new innovative medicines. Methods: We approached drug access issues in two perspectives: approval lag (or availability) and reimbursement lag (or affordability). The issues were identified and evaluated through the review of literature, public documents, reports published by the government agencies and private organizations, and news articles. Results: To shorten approval lag, it is recommended to hire and train more reviewers at the Ministry of Food and Drug Safety. Increasing user fees to a realistic level can facilitate this process. To reduce reimbursement lag, flexible incremental cost-effectiveness ratio threshold, alternative cost-effectiveness evaluation, and establishment of funding source other than the national health insurance are identified as the areas to be improved. Conclusion The current policies and regulations had to be supplemented by new systems to drastically promote patient accessibility to new drugs, consequently in order to promote national public health.

Objective: This study aimed to overview and assess the effectiveness of the policies and regulations that have governed new drug access in Korea, and to propose policies to enhance patient access to drugs, particularly for new innovative medicines. Methods: We approached drug access issues in two perspectives: approval lag (or availability) and reimbursement lag (or affordability). The issues were identified and evaluated through the review of literature, public documents, reports published by the government agencies and private organizations, and news articles. Results: To shorten approval lag, it is recommended to hire and train more reviewers at the Ministry of Food and Drug Safety. Increasing user fees to a realistic level can facilitate this process. To reduce reimbursement lag, flexible incremental cost-effectiveness ratio threshold, alternative cost-effectiveness evaluation, and establishment of funding source other than the national health insurance are identified as the areas to be improved. Conclusion The current policies and regulations had to be supplemented by new systems to drastically promote patient accessibility to new drugs, consequently in order to promote national public health.

BACKGROUND: Little knowledge is available on the characteristic differences between patients with atopic dermatitis (AD) with and without atopic march after childhood. OBJECTIVE: To observe and compare the phenotypes of patients with AD in regards to atopic march tendency at a single point. METHODS: We enrolled patients with AD aged between 10 and 30 years. The patients were divided into the atopic march and non-atopic march groups on the basis of an investigator-designed survey questionnaire, and their serum-specific immunoglobulin E (IgE) levels or results of the skin prick test were compared. RESULTS: In a total of 182 patients enrolled in the study, 93 patients with atopic march and 89 patients with non-atopic march were observed. When their serum-specific IgE levels or results of the skin prick test were compared between the two groups, there was no significant difference, except for a in the atopic march group. Analysis of AD severity, family history of allergic diseases, and total IgE levels between the two groups showed no statistically significant differences. CONCLUSION: Our findings suggest that although no apparent phenotype characteristics could differentiate the presence of atopic march, the history of the patient's allergic diseases should be revalidated, and clinicians should watch out for future developments of atopic march when a patient shows a high-class sensitization rate to dust mite.
Dermatitis, Atopic* ; Dust ; Humans ; Immunoglobulin E ; Immunoglobulins ; Mites ; Phenotype ; Skin

No abstract available.
Diagnostic Errors* ; Scleroderma, Localized* ; Vitiligo*