We would like to correct the affiliation for the first author.

No abstract available.
Esophagus*

Along with the enactment of a law separating the prescribing and dispensing of drugs in Korea in 2000, attempts at reducing medical expenses by generic substitution have been allowed since August 2001 so long as generic products are bioequivalent to the original products. In the pharmaceutical industry, the required development and investment to make generic products are much less in terms of time and money. Thus, the number of bioequivalence studies in Korea has increased. This has resulted in the need for bioequivalence recommendations (guidelines), taking into account the circumstances of the Korean pharmaceutical industry. In this paper, we provide procedures for making bioequivalence determinations for individual products acting on the circulatory system (30 drugs, 2011), the components of which are widely accepted for the development of generic products in Korea. These recommendations correspond with international guidelines, such as those of the US FDA and EMEA. For the 30 drugs that act on the circulatory system, we examined each in terms of subject selection (healthy volunteers vs. patients), dosage strength, dosage route, analytes to measure, and evaluation parameters, and prepared bioequivalence recommendations for individual products through an analysis of many published papers, US FDA and EMEA guidelines, and clinical trial websites. Based on the bioequivalence recommendations for individual products, we had several meetings in which KFDA officers (members of the New Drug Research team and the Office of Generic Drugs), three pharmacy professors with expertise in drug analysis and pharmacokinetics, and three professors of medicine with extensive experience in clinical trials participated to confirm and discuss the contents. Finally, the bioequivalence recommendations for individual products were provided on the KFDA website. The individual bioequivalence recommendations have been used by KFDA officers in drug evaluations and bioequivalency testing to improve consistency, clarity, and professionalism in the drug evaluation process. These recommendations will be useful for domestic pharmaceutical companies by shortening the time and cost associated with bioequivalence studies, especially in terms of standardized trial designs, dosage forms, and analytical methods.
Dosage Forms ; Drug Evaluation ; Drug Industry ; Drug Substitution ; Drugs, Generic ; Investments ; Jurisprudence ; Korea ; Pharmacy ; Therapeutic Equivalency

PURPOSE: To determine the locations and incidences of sesamoids and accessory bones of the forefoot in normal Korean adults. MATERIALS AND METHODS: The plain radiographs of the forefoot of 400 volunteers, 200 males and 200 females, were taken. The three orthopedic surgeons participated in the radiographic evaluation independently. Persons who had history of foot problem or injury were excluded. RESULTS: Sesamoids of first metatarsophalangeal joint were nearly always present; medial 99% and lateral 100%. The bipartite sesamoid was more common in medial (9.8%) and in female (17.0%) than in lateral (0.3%) and in male (2.5%). Sesamoids of the interphalangeal joint of the first toe were seen in 35.8%. Sesamoids of metatarsophalangeal joints in other four toes were rarely observed. Their incidences were 5% in second toe, 0.8% in third, 0% in fourth, and 2.8% (lateral) and 7.5% (medial) in fifth. Sesamoids of interphalangeal joint in four lesser toes were not observed except two cases (0.5%) in the fifth toe. Accessory bone was very rarely observed. Os vesalianum was observed in five feet (1.3%), Os intermetatarseum in 14 feet (3.5%), and Os cuneo-metatarsal I tibiale in none. CONCLUSION: We determined the location and incidences of sesamoids and accessory bones of the forefoot, and we expected this to help to diagnose the forefoot problem.
Adult* ; Female ; Foot ; Humans ; Incidence ; Joints ; Male ; Metatarsophalangeal Joint ; Orthopedics ; Toes ; Volunteers

PURPOSE: To determine the locations and incidences of sesamoids and accessory bones of the forefoot in normal Korean adults. MATERIALS AND METHODS: The plain radiographs of the forefoot of 400 volunteers, 200 males and 200 females, were taken. The three orthopedic surgeons participated in the radiographic evaluation independently. Persons who had history of foot problem or injury were excluded. RESULTS: Sesamoids of first metatarsophalangeal joint were nearly always present; medial 99% and lateral 100%. The bipartite sesamoid was more common in medial (9.8%) and in female (17.0%) than in lateral (0.3%) and in male (2.5%). Sesamoids of the interphalangeal joint of the first toe were seen in 35.8%. Sesamoids of metatarsophalangeal joints in other four toes were rarely observed. Their incidences were 5% in second toe, 0.8% in third, 0% in fourth, and 2.8% (lateral) and 7.5% (medial) in fifth. Sesamoids of interphalangeal joint in four lesser toes were not observed except two cases (0.5%) in the fifth toe. Accessory bone was very rarely observed. Os vesalianum was observed in five feet (1.3%), Os intermetatarseum in 14 feet (3.5%), and Os cuneo-metatarsal I tibiale in none. CONCLUSION: We determined the location and incidences of sesamoids and accessory bones of the forefoot, and we expected this to help to diagnose the forefoot problem.
Adult* ; Female ; Foot ; Humans ; Incidence ; Joints ; Male ; Metatarsophalangeal Joint ; Orthopedics ; Toes ; Volunteers

BACKGROUND: The treatment goal for patients with chronic hepatitis B infection is to prevent progression of the disease to cirrhosis and hepatocellular carcinoma. Current therapies include standard and pegylated interferon-alfa and nucleoside/nucleotide analogues: lamivudine, adefovir, entecavir, telbivudine, clevudine, and tenofovir. This study aims to analyze changes in the prescribing patterns of chronic hepatitis B (CHB) medications in South Korea between 2013 and 2014. METHODS: A cross-sectional study was conducted using National Patients Sample data compiled by the Health Insurance Review and Assessment Service from 2013 and 2014. Patients with CHB were identified with Korean Standard Classification of Diseases code-6 (B18.0 and B18.1) and those who were maintaining active prescriptions with CHB medications covering the index date (December 1(st), each year) were included. The utilization of antiviral therapy was investigated during 2013 and 2014. RESULTS: A total of 4,204 and 4,552 patients in 2013 and 2014 respectively, were included in the analysis. The proportion of male patients was two of third and the patients 41-60 years old accounted for 60% of all analyzed patients. The most utilized drug was entecavir (55.1% in 2013 and 44.8% in 2014) and the second most utilized drug was tenofovir in both years (18.8% in 2013 and 29.0% in 2014). The percentage of combination therapy was 13.6% and 13.1% in 2013 and 2014, respectively. The proportion of tenofovir prescriptions was increased in 2014 compared with 2013. CONCLUSION: With the development of new drugs and the changes in clinical practice guidelines, the prescription pattern of the antiviral agents for patients with CHB has changed. The rate of utilization of tenofovir has increased.
Antiviral Agents ; Carcinoma, Hepatocellular ; Classification ; Cross-Sectional Studies ; Drug Utilization* ; Fibrosis ; Hepatitis B, Chronic* ; Hepatitis, Chronic* ; Humans ; Insurance, Health ; Korea ; Lamivudine ; Male ; Prescriptions ; Tenofovir